With a nod to the immortal phrase, “Bring out your dead!  Bring out your dead!” uttered by body collector Eric Idle, and to the Knights Who Say “Ni!,” from the 1975 comedy romp, Monty Python and the Holy Grail, in calling attention to Drug Enforcement Administration’s 27th National Prescription Drug Take Back Day, we say “Bring out your meds!  To the Feds!” to you.

Unwanted and expired controlled prescription medication languishing in medicine cabinets are prime candidates for theft, misuse and abuse.  DEA and its law enforcement partners will once again host local drop-off locations nationwide for safe disposal of unneeded medication on Saturday, April 26, 2025, from 10:00 a.m. to 2:00 p.m. local time.

DEA holds the ever-popular drug take back event each spring and autumn.  Last October’s Take Back Day collected almost 620,000 pounds, or 314 tons, of unneeded medication at over 4,600 collection sites nationwide.  DEA has collected over 19.2 million pounds, or 9,600 tons, of unneeded medication since 2010.  Additional information about National Prescription Drug Take Back Day, including disposal locations, can be found at: https://www.deadiversion.usdoj.gov/drug_disposal/takeback/takeback.html.  DEA’s Diversion Control website also lists permanent year-round drug disposal locations and provides other disposal information.

So, gather the kids and tell the neighbors, “Bring out your meds!  To the Feds!”

Hyman, Phelps & McNamara, P.C. is hosting a free webinar on recent and forward-looking enforcement under the Federal Food, Drug & Cosmetic Act on Thursday, May 1, 2025, from 12:00 p.m. to 1:30 p.m. (ET) (register here).

Join us as HPM’s Anne Walsh moderates a panel discussion with three former DOJ attorneys who all litigated extensively under the FDCA.  The panel will include J.P. Ellison, a former trial attorney at DOJ’s Consumer Protection Branch (CPB), John Claud, a recent Assistant Director at CPB, and Andrew Hull, a former Assistant U.S. Attorney.

Equipped with significant FDC Act prosecution experience from their years as federal prosecutors, the panelists will address questions about how an FDC Act case is prosecuted, recent FDC Act enforcement cases, and what to expect under the new administration.  The panelists will also share their predictions on the increased role of state agencies and other prosecutions in the FDA space.

We hope you will join us for this exciting and relevant discussion.  Click here to register.

In January 2025, FDA posted the 2024 Annual Report concerning the Accreditation Scheme for Conformity Assessment (ASCA) program as required by Medical Device User Fee Amendments of 2017 (MDUFA IV).   As we previously blogged, under the FDA Reauthorization Act of 2017 (FDARA), FDA committed to establish an ASCA Program using FDA-recognized consensus standards.  The ASCA pilot program concluded in 2023 after seven (7) years based on data demonstrating the pilot’s objectives were met or surpassed.

Under the ASCA program, FDA grants ASCA Recognition to qualified accreditation bodies to accredit testing laboratories, thereby granting the laboratories ASCA Accreditation.  The ASCA accredited testing laboratories perform testing for medical device companies to include in premarket submissions.   A Sponsor can choose to use an ASCA accredited laboratory for basic safety and essential performance and/or biocompatibility testing.

ASCA is designed to

• Enhance confidence in medical device testing;
• Promote consistency and predictability in the premarket review process;
• Encourage effective use of FDA resources;
• Enhance regulatory efficiency; and
• Support international harmonization.

When using ASCA, Summary Test Reports are included in a premarket submission using the format provided in the ASCA standards-specific guidance documents. Summary Test Reports and Declarations of Conformity include all critical data and testing conditions so that full test reports are not needed, making FDA’s review of the data during the submission more efficient.  FDA has stated by including ASCA Summary Test Reports in submissions,  they “will have confidence in the testing laboratories’ test methods and results.”

According to the ASCA 2024 Annual Report, the FDA received seventy-one (71) device submissions that contained ASCA accredited laboratory Summary Test Reports, a significant increase over the five (5) submissions received in 2022. While the number of submissions containing ASCA Summary Test Reports is growing, the numbers still appear to be low given the number of submissions FDA receives for devices that are required to include basic safety and essential performance or biocompatibility  documentation.

The majority of device submissions that included ASCA Summary Test Reports were for basic safety and essential performance, with only 25% for biocompatibility.  The good news is that out of the seventy-one (71) submissions noted in the 2024 Annual Report, only one (1) submission had deficiencies and only one (1) submission required FDA to request a full test report.  The fact that the majority of submissions that included ASCA Summary Test Reports successfully met biocompatibility and basic safety and essential performance requirements—which are areas Sponsors typically receive Additional Information requests—suggests the training provided by ASCA to both laboratories and Sponsors is paying off.  Prior to November 2023, FDA identified administrative and technical deficiencies in approximately 37% of submissions with ASCA Summary Test Reports during the pilot phase of the program.

As of December 2024, there are now 107 testing laboratories under ASCA Accreditation (102 for basic safety and essential performance and five (5) for biocompatibility), which gives Sponsors seeking to avail themselves of the ASCA program many options.  It should be noted, however, six (6) laboratories did request to withdraw from the program, for reasons not disclosed in FDA’s Annual Report.

As FDA’s concerns related to unreliable device biocompatibility testing data continue (see our blog post here), Sponsors may want to consider evaluating if an ASCA accredited testing laboratory could be a means to ensure the quality of their biocompatibility test data. In addition, Sponsors seeking to improve their device submission predictability, may want to consider an ASCA accredited testing laboratory for basic safety and essential performance and biocompatibility testing.

FDA’s Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter of 2025 to Taiho Oncology (Taiho) for a healthcare provider branded website for its drug LYTGOBI (futibatinib). This letter, dated March 21, 2025, cites Taiho’s false or misleading representations about the benefits of the drug, which is considered misbranding under the Federal Food, Drug, and Cosmetic Act. The letter is notable as it is the second OPDP enforcement letter describing violative promotion about an accelerated approval drug within the last six months. Join us as we break down what went wrong this time.

What Happened?

LYTGOBI was granted accelerated approval for the treatment of adult patients with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma (iCCA) with FGFR2 gene fusions or rearrangements. The FDA’s accelerated approval pathway can allow for earlier approval of drugs intended to treat serious conditions and fill an unmet medical need where approval is based on an effect on a surrogate or intermediate clinical endpoint that is reasonably likely to predict clinical benefit and the predicted clinical benefit is subsequently verified in a post-approval confirmatory trial(s). The Untitled Letter notes that the confirmatory trial for LYTGOBI is currently ongoing and has not been completed; therefore, clinical benefit of LYTGOBI has not yet been confirmed.

OPDP’s concerns center on Taiho’s “Efficacy Results” webpage, which highlights Kaplan-Meier survival curves for progression-free survival (PFS) and overall survival (OS), along with data from additional endpoints, from Taiho’s Phase 2 study, FOENIX-CCA2. The problem? As a single-arm trial (i.e., no comparator arm), FOENIX-CCA2 was not capable of establishing improvement on time-to-event efficacy endpoints such as PFS or OS and, without an appropriate comparator, “it is not possible to determine if the observed effect is attributable to LYTGOBI or to other factor(s), such as the natural history of the disease.” The website also reports a disease control rate (DCR) of 83% based on a non-prespecified follow-up analysis conducted 8 months after the primary analysis. DCR is defined as “the sum of complete response (CR), partial response (PR) and stable disease (SD).” However, the Untitled Letter describes the single-arm FOENIX-CCA2 trial could not establish that the observed SD was attributable to the effect of the drug so the webpage misleadingly suggests that LYTGOBI improves DCR in patients with locally advanced or metastatic iCCA based on a composite of CR, PR, and SD. The Untitled Letter states that a randomized controlled trial would be needed to assess delay in time to disease progression.

Taiho’s website also featured (less prominently) a number of disclaimers such as, “This data presentation is neither intended to draw conclusions regarding the efficacy of LYTGOBI nor to imply that there is a treatment effect of LYTGOBI on these time-to-event endpoints and the results should be interpreted with caution,” and “The extended follow-up data were collected after the primary analysis and are descriptive in nature, and results should be interpreted with caution.”

Not surprisingly, these disclaimers were simply not enough. The FDA emphasizes that intrahepatic bile duct cancers have an estimated 5-year relative survival rate and unresectable, locally advanced or metastatic iCCAs, such as those for which LYTGOBI is conditionally approved, is a serious public health concern where surgery is not an option and treatment for the condition involves serious risks. In such serious cancers, survival data is one of the most critical factors influencing treatment decisions and disclosures of the FOENIX-CCA2 trial’s limitations on the webpage do not correct or mitigate the misleading representations or suggestions of LYTGOBI’s efficacy.

Echoes from Past Warnings

The disclaimers included on the website were likely derived from FDA commentary on previously submitted marketing pieces. According to the Untitled Letter, the FDA previously pointed out concerns about Taiho’s marketing messages, particularly regarding the selective presentation of efficacy data. With this latest Untitled Letter, the Agency is sending another strong signal that failure to correct misleading claims could lead to harsher consequences.

But, where have we heard this all before? The Taiho Letter has almost identical observations to those cited in the 2024 Untitled Letter to Mirati Therapeutics Inc. (Mirati) about a healthcare professional branded website for KRAZATI (adagrasib). Promotion for KRAZATI, which was granted accelerated approval for patients with certain types of non-small cell lung cancer, was objectionable because of claims about DCR, OS and PFS based on a single-arm study. In that case, as in this instance, the inclusion of disclaimers did not mitigate the misleading impression left by the claims.

Both cases involve oncology drugs granted accelerated approval. Accelerated approval requires companies to submit all promotional materials for their product thirty (30) days in advance of the material being used. FDA did not object to the timing of the respective submissions in either letter.

Promoting Accelerated Approval Drugs

Taiho now faces a choice: revise its marketing approach or risk further regulatory action from the FDA.

Separately, these bloggers wonder whether the Untitled Letter to Taiho signals a specific focus on accelerated approval product promotion. Unlike the Untitled Letter to Mirati, the Taiho Letter includes no reference to FDA’s Bad Ad program – indicating that Taiho’s materials were on OPDP’s radar for other reasons. This newest letter makes 1/3 of the letters issued by OPDP over the past 12 months directed toward promotion of accelerated approval drugs. (Lest we be accused of overstating, in absolute numbers this means two out of the six Untitled Letters OPDP has issued.)

Marketing an accelerated approval drug can be messy. Marketers are often put in the difficult position of submitting materials 30 days in advance of use and then having to decide whether to “go live” with those materials when comments have not been received from FDA within that time frame. As readers of enforcement letters, we have the benefit of 20/20 hindsight when looking at promotional material, seeing study limitations disclosures and knowing they were insufficient to contextualize the representations. However, companies oftentimes need to make risk/benefit decisions about how to proceed with messaging and including disclosures/disclaimers is critical to ensuring presentations can be defended as truthful and non-misleading.

While it is our understanding OPDP staff responsible for reviewing advertising and promotional materials were not subject to the April 1 reduction-in-force, other areas of OPDP were impacted, which may lead to longer promotional material review timelines. Given these recent changes, these bloggers wonder whether the Taiho Letter may be the last Untitled Letter we see for some time, as the remaining FDA staff continue to navigate these unprecedented times. While we don’t always see eye-to-eye with OPDP reviewers when determining whether a communication is false or misleading, we’ve always appreciated that their perspective is grounded in FDA’s mission to protect the public health.

Last month, we blogged on the Department of Justice’s (DOJ) abrupt announcement that it had determined that removal restrictions protecting administrative law judges (ALJs) were “unconstitutional” and that DOJ would no longer defend those removal restrictions in court.  We opined that while the impact of this statement was unclear, it was likely that this position would make it more difficult for litigants challenging the constitutionality of a proceeding presided by an ALJ.

That’s precisely what happened in a recent decision out of the U.S. District Court for the District of Rhode Island in a case challenging a DEA ALJ’s authority to preside over a hearing as to whether the plaintiff’s application for a DEA registration should be granted or denied.  In MMJ BioPharma Cultivation, Inc. v. Bondi, No. 24-CA-127 (D.R.I.), the plaintiff—a company seeking to obtain a DEA registration to cultivate marijuana for research purposes—applied for a DEA registration, and then received an order to show cause from DEA as to why the agency should not deny its application.  The plaintiff requested a hearing before an ALJ, but then filed the lawsuit in federal court seeking injunctive relief and arguing that the constraints on the President’s power to remove DEA ALJs are “unconstitutional.”

The Court granted DOJ’s motion to dismiss.  Specifically, the Court held that the plaintiff failed to state a claim for injunctive relief because it did not demonstrate that it would suffer “irreparable harm” absent the requested relief, a key requirement for granting injunctive relief.  The Court noted the difference between “appointment” challenges—contesting the constitutional validity of the appointment of the officer adjudicating a case—and “removal” challenges, which address whether an officer is improperly protected from removal by the President.  The Court explained that just “because an officer is unconstitutionally protected from removal does not mean that they lack constitutional authority to carry out the role for which they were appointed.”  Id. at 5.  Instead, “there must be a showing that the unconstitutional [removal] provision affected or likely will affect the decision.”  Id. at 6.

Because the plaintiff solely pleaded that it was entitled to relief because the DEA ALJ presiding over its case was unconstitutionally protected from removal—and did not allege how these removal protections affected or were likely to affect DEA’s adjudication of its case—the Court dismissed the case.

We will continue monitoring other attempts to challenge the authority of DEA’s ALJs to preside over hearings, but, as we predicted, we expect that other attempts will face similar hurdles.

The recent and drastic Reduction In Force (RIF) at the U. S. Food and Drug Administration (FDA) is already having ripple effects not just internally, but across the broader regulatory and life sciences communities and the public at large. While much of the focus has been on how these cuts may impact application review timelines and industry engagement, see earlier post about the effect on generic drugs, another quieter consequence is emerging – a significant slowdown in the availability of information that FDA is required to produce under the Freedom of Information Act (FOIA).

FOIA is a U.S. federal law enacted in 1967 to promote transparency and accountability in the federal government by granting the public the right to request access to government records, subject to certain exemptions. As it relates to the FDA, FOIA serves as a vital tool for stakeholders – including patients, researchers, and regulated industry – to better understand the Agency’s scientific, policy and regulatory decision-making.

Documents that FDA discloses in response to FOIA requests can vary widely, from inspectional documents, like Form 483s and Establishment Inspection Reports, to correspondence between FDA and sponsors, and can be voluminous, such as 510(k) documents and other review memos. However, not all information contained in FDA records is disclosable. Under the law, FDA can redact or withhold information that falls under one of nine exemptions; the most commonly used exemptions are: information that describes FDA’s internal deliberative processes (Exemption 2), information that is prohibited from disclosure by other laws (Exemption 3), confidential commercial or financial information or trade secrets (Exemption 4), inter-agency and intra-agency communications (Exemption 5), information that could lead to an invasion of personal privacy of individuals (Exemption 6), and records or information compiled for law enforcement purposes (Exemption 7).

As a result of the RIF, stakeholders are now seeing longer wait times for both requested documents via FOIA and proactive disclosures, like approval packages routinely posted on Drugs@FDA which are required under the Food and Drug Administration Amendments Act (FDAAA)  to be posted within 30 calendar days of approval for new products or within 30 calendar days of the third FOIA request for the action package. In some cases, previously routine postings are delayed or going unpublished altogether. We also have heard from the remaining FDA FOIA staff that it could be at least a month before they can even provide a new estimate for when to expect responses under pending FOIA requests. For those requestors who already have been waiting months (or even years) for FDA to provide the documents that FDA put on a “complex” track, the staffing cuts are hugely disappointing.  Although there are avenues for escalating or litigating unreasonable delays for responding to FOIA requests, it is difficult to see how these approaches will be effective as no one may even be available to respond to an appeal until the dust settles.

Transparency has long been a cornerstone of FDA’s public health mission, and one that the new HHS Secretary and FDA Commissioner have reinforced as their priorities. But in these unprecedented times, as the Agency navigates the strain of recent workforce reductions, the ripple effects are increasingly hard to ignore. What began as a staffing challenge is quickly becoming an information bottleneck—one that threatens to erode the transparency that stakeholders rely on. If access to critical regulatory documents continues to slow or stall, the consequences could extend beyond inconvenience, ultimately impacting the ability of patients, providers, and developers to make informed decisions that affect public health.

The FDA Reduction-in-Force (Termination)—or “RIF(T)”—announced last week has resulted in countless stories in the press and on personal LinkedIn accounts from those RIF’d.  As the dust begins to settle and we all assess what this means for the future of FDA and the public health, generally, this blogger wanted to call out one particular division in the Office of Generic Drugs (OGD), funded by user fees under the Generic Drug User Fee Amendments (GDUFA), that was eradicated and what that might mean for the immediate future of generic drugs in America: the Division of Policy Development in the Office of Generic Drug Policy (OGDP), which was created in late 2013/early 2014 in part to implement the first iteration of GDUFA.

OGDP is one of several offices in OGD, and it was composed of three divisions: the Division of Legal and Regulatory Support, the Division of Orange Book Publication and Regulatory Assessment, and the Division of Policy Development (DPD).  As folks steeped in the world of generic drugs and Hatch-Waxman know, there’s a lot that happens before FDA can take action on an ANDA.  And DPD was a significant piece of that puzzle.

Among other things, DPD’s functions included:

• Facilitating the development, clearance, and publication of Product-Specific Guidances (PSGs). This included ensuring FDA consensus on the recommendations in the PSGs and working with the Office of the Commissioner to ensure their timely publication, either in “quarterly batches” of PSGs or as a “stand-alone” PSG when ANDA bioequivalence recommendations may be the subject of a pending Citizen Petition.  Indeed, since 2014, DPD facilitated the publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents (g., the ICH M13A batch), totaling more than 3,000 PSGs (including PSG revisions).  About one third of these PSGs are for complex products and many reflect what OGD and DPD learned about the science of equivalence from GDUFA-funded regulatory science research.
• Leading FDA’s implementation of the Drug Competition Action Plan (DCAP). The DCAP was an initiative launched in 2017 to remove barriers to generic drug development, approval, and market entry (see our previous post here).  Under DCAP, DPD published dozens of guidance documents and Manual of Policies and Procedures (MAPPs), and completed many other initiatives in support of increased drug competition (g., facilitating the twice annual updates to the Off-Patent, Off-Exclusivity List).

• Publishing virtually every GDUFA guidance and MAPP since 2014 to fulfill FDA’s GDUFA commitments. Under GDUFA III alone, DPD published 32 GDUFA guidance documents and MAPPs to ensure the successful implementation of GDUFA.  DPD met all of the GDUFA commitments to publish policy documents (Section IX of the GDUFA III Commitment Letter) and published many others the Division determined would provide clarity to the generic drug industry.

• Processing voluntary ANDA withdrawals under 21 C.F.R. § 314.150(c). These Federal Register notices help generic drug sponsors clean up their ANDA portfolios and sometimes lower their GDUFA program fees.  Since 2019, when DPD took over this process, the Division has published more than 600 ANDA withdrawals at the request of generic drug manufacturers.

• Managing the process of issuing Covered Product Authorizations (CPAs) under the CREATES Act. This facilitated generic manufacturer’s access to samples of brand-name drugs not readily available through normal market channels for generic drug development.  Since the inception of the program, DPD reportedly met every GDUFA goal date for timely issuance of a CPA.

• Leading FDA’s policy implementation of the MODERN Labeling Act, the statutory authority allowing FDA to make certain generic drug labeling updates.

• Providing significant policy support to the annual update of the Orange Book Preface.

• Overseeing the development, clearance, and issuance of every policy document FDA issued on generic drugs. And, as you can see from FDA’s 2025 CDER Guidance Agenda, DPD was working on guidance documents from 180-day generic drug exclusivity, 3-year exclusivity, 30-month stays, pediatric exclusivity, comparative analyses for drug-device combination products, and many other guidance documents on generic drug “sameness” (including, we understand, a  revised version of the May 2021 guidance, titled “ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin” that  would have provided scientific and regulatory clarity for the development of ANDAs for generic versions of brand-name GLP-1 drugs.)

DPD also did quite a bit of additional behind-the-scenes work to support and facilitate ANDAs and OGD generally.  For example, DPD worked with subject matter experts from across FDA to clarify the scientific and regulatory pathway for the transition of generic metered-dose inhalers to different propellants, and presented publicly on this topic in December 2024.  But that’s all in the past now.  How these functions critical to the development and approval of generic drugs will now be handled (and by whom) is unclear.  But what seems quite clear is this: generic drug access, availability, and affordability will suffer without DPD.  We can only hope that the powers that be will promptly reconsider this move.

Promotional claims do not receive the most attention with respect to FDA enforcement these days, and veterinary promotion is no exception.  Indeed, most Center for Veterinary Medicine (CVM) Warning Letters arise because products advertised are actually new animal drugs.  But this year, CVM has issued two notable warning letters and one Untitled Letter concerning the promotion of animal drugs that caught our attention because of the level of detail and specificity included.  The detail with which CVM reviewed these promotions is reminiscent of OPDP/DDMAC letters of yore.

Let’s take a look at these letters:

Back in January 2025, CVM issued a Warning Letter to animal drug sponsor Elanco Animal Health.  Elanco is the manufacturer of recently approved Zenrelia (ilunocitinib tablets) (September 2024), which is indicated for “control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.”  Zenrelia comes with serious warnings, including a boxed warning against the use of Zenrelia during vaccination.  However, several of Zenrelia’s promotional materials—specifically, FDA looked at a consumer-directed website, a product brochure and risk tracker, and a slide deck—omitted the specific phrase “from modified live virus vaccines” from the boxed warning found in the Important Safety Information.   The omission of the one short phrase, the Warning Letter says, is “misleading” because fatalities in the vaccine safety study used to support the New Animal Drug Application “occurred after administration of a MLV DHPP vaccination, a core vaccination for all dogs.”  The omitted phrase therefore provided “material facts that may be relevant to prescribing veterinarians and dog owners.”   CVM also objected to the truncation of other information about the timing of vaccines in these promotional materials.

Zenrelia promotional materials also included claims about clinical data that the Agency found actionable.  The Warning Letter alleged that the veterinarian product website made claims about a Vaccine Safety Study relied upon for approval that directly conflict with the PI.  Further, information presented on the adverse reaction data was inconsistent with the PI.  And, going into detail about the primary effectiveness endpoint, FDA raised concerns about claims allegedly exaggerating the speed of action for Zenrelia (i.e. that it is effective on “Day 1”) and insinuating  misleading comparative claims.

Not long after, in February 2025, FDA raised similar objections to promotional materials for Aurora Pharmaceutical’s three products, Altren (altrenogest) for suppression of estrus in mares, SwineMate (altrenogest) for synchronization of estrus in pigs, and Barrier (imidacloprid and moxidectin) for the prevention of heartworm in dogs, the first two which have “serious user safety warnings” and the third a boxed warning regarding exposure.  Reviewing the company website, CVM determined that it included “false or misleading claims and representations about the safety and effectiveness of these products,” thereby misbranding the product.  With respect to Altren, the webpage fails to contain any risk information, and a Product Sheet presents benefits and effectiveness information in a large, bulleted format while the risk information is in a smaller font on the second page.  It also omits risk information about the handling of the product.  For SwineMate, CVM objected to omission of information related to risks to humans, as well as important animal safety warning language, creating “a misleading impression about the consequences associated with using the drug.” The website also fails to include adequate directions for use.  And its Product Sheet suffers from the same infirmities as the Altren Product Sheet.  Finally, the website for Barrier for Dogs fails to contain any risk information, including the boxed warning from the PI.  And the Barrier Product Sheet included seven pages of benefit information, but risk information is presented only on a single page, in a smaller font, at the end of the brochure.

Finally, CVM issued an Untitled Letter in February 2025 to Zoetis due to promotional claims found on its Petcare YouTube Channel about the Company’s Librela (bedinvetmab injection), Solensia (frunevetmab injection), and Revolution Plus (selamectin and sarolaner topical solution).  FDA here cited false and misleading claims and representations about the risks associated with these products.  Specifically, the Librela ads show before and after treatment with no risk information, thereby making efficacy claims without fair balance, particularly because the Important Safety Information is not visible unless the viewer clicks on the “more” button to expand the text box.  Additionally, a video for Librela and two videos for Solensia contain voice-overs that discuss risk information related solely to the potential for self-injection by veterinary professionals who administer the drug without identification of the risks to the animal.  CVM stated that the “videos are misleading because they are aimed at the pet owner, yet they omit important safety and risk information for the animal species the drug is approved to treat. While there is some animal-related risk information included in superimposed text at the bottom of the video screen for a portion of the video….”  The safety text that is included is also small and difficult to read compared to the effectiveness claims.  Finally, a video for Revolution Plus titled “How to Apply REVOLUTION PLUS to Your Cat” is misleading because pictures of a child hugging a cat to whom Revolution has been applied implies that there are no safety concerns regarding humans interacting with any part of the cat after application of Revolution Plus, which is in direct conflict with the information in the Human Warnings section.

Zoetis and Elanco have previously been the target of CVM complaints about their promotion: Of 10 ULs issued by CVM re advertising since 2014, Zoetis received 4 – one in 2025, 2023, 2018 and 2016 and Elanco received 2 ULs – 1 in 2018 and another in 2015.

The allegations in the Warning Letters are serious, but that’s not why they’re so interesting.  They are that interesting because it’s not every day that we see Warning Letters and Untitled Letters with this level of promotional scrutiny coming out of CVM.  FDA really delved into the claims and the support for the claims on a level typically reserved for human drugs.   FDA’s review here of the claims for these animal products is reflective of the high standards to which FDA holds all promotion—human or otherwise.   We note that CVM has issued even more enforcement actions in 2025 than on the human side: OPDP has issued 2 Untitled Letters so far in 2025 compared with CVM’s 3 enforcement actions.  While OPDP has been scaling back its enforcement, CVM might be stepping it up.

Let this serve as reminder to veterinary companies: FDA is watching.

Come together with leaders from the pharmaceutical, biotechnology, and diagnostic industries to unpack huge changes at the American Conference Institute’s 23rd Advanced Summit on Life Sciences Patents, which is scheduled to take place from May 19-20, 2025 at the New York Bar Association in New York, NY.  In a year of major change and outstanding questions, growing scrutiny on patent protection and drug pricing, and uncertainty around global price control measures and the Inflation Reduction Act, understanding the implications of new leadership and emerging mandates is critical.

Gain insights from leading in-house counsel, patent prosecutors, litigators, and the US Patent and Trademark Office.  In addition, attendees will explore strategies to maximize patent terms, navigate the Unified Patent Court, and address key prosecution challenges.

Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will speak at a session, titled “Hitting the Books: Examining Orange and Purple Book Delisting from a Patent Prosecutorial Perspective,” along with co-presenters Kim Braslow (Senior Director, IP and Government Affairs, AstraZeneca) and Nicole Woods (Associate Vice President, Assistant General Patent Counsel, Eli Lilly and Company).

FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount.  The discount code is: D10-999-FDA25.  You can access the conference brochure and sign up for the event here.  We look forward to seeing you at the conference!

Last week, the Supreme Court issued a unanimous decision in FDA v. Wages & White Lion Investments, LLC, No. 23-1038 (Apr. 2, 2025) that affirms FDA’s denial of authorization to market flavored vape products. This opinion, which overrules a Fifth Circuit decision that FDA had acted arbitrarily and capriciously in denying premarket tobacco product applications submitted by manufacturers of flavored e-liquids for open-system e-cigarettes, marks the latest development in the ongoing debate and FDA regulation of flavored vape products.

By way of background, when FDA issued its rule in 2016 that deemed e-cigarettes and e-liquids to be tobacco products subject to regulation under the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA), it required manufacturers of these products to obtain marketing authorization by submitting a premarket tobacco product application for their e-cigarette and e-liquid products (you can read more about the so-called “deeming rule” in our prior post here).

Following several years of delayed enforcement, FDA began reviewing a first wave of applications.  To the manufacturers’ chagrin, FDA squarely rejected approximately 1.2 million product applications belonging to 320 applicants—including the respondents—concluding that the manufacturers failed to provide sufficient product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth.  Specifically, FDA cited the lack of “evidence from a randomized controlled trial, longitudinal cohort study, or another reliable and robust method that desert-, candy-, and fruit-flavored products had benefits over an appropriate comparator tobacco-flavored product.”  Id. at 16.

The manufacturers called foul, asserting that they had relied on a number of statements from FDA officials and guidance that suggested such product-specific and comparative scientific evidence would not be necessary.  In a scathing decision, an en banc panel of the Fifth Circuit agreed with the respondents, holding that FDA acted arbitrarily and capriciously and performed a “surprise switch” by “unquestionably chang[ing] its position and then pretend[ing] otherwise.”  (See our prior post on the Fifth Circuit’s decision here).

The Supreme Court overruled the Fifth Circuit, holding that FDA had not acted in an arbitrary and capricious manner.  Noting that respondents challenged the agency’s pattern of seemingly changing requirements and positions, the Court applied its “change-in-position doctrine.”  The doctrine acknowledges that “agencies are free to change their existing policies as long as they provide a reasoned explanation for the change,” “display awareness that they are changing position,” and “consider serious reliance interests.”  Id. at 22.  As a first step, the Court ascertains whether the agency has actually changed an existing policy.

Here, the Court found that FDA had not, in fact, changed an existing policy.  Sorting through a litany of statutory provisions, regulations, guidance documents, and public statements, the Court found that FDA never laid out a clear test on the type of scientific evidence necessary to support the manufacturers’ applications, and that FDA had made no hard-and-fast commitment as to the minimum evidence required for authorization.  The Court held that it was a “fair summary” of FDA’s position that (a) it was not essential for manufacturers to submit evidence based on well-controlled investigations, but (b) if they did not do so, they would have to provide rigorous scientific evidence that the sale of their products would be appropriate for the protection of the public health.  Id. at 28.

In short, FDA had provided “largely noncommittal guidance.”  Id. at 29.  Frustrating as that may be for the manufacturers, FDA’s denial orders did not constitute a change in existing policy.  The Court similarly found that requirements for comparative efficacy studies (comparing the health effects of the manufacturers’ non-tobacco flavored products to those of tobacco-flavored products), and FDA’s general approach of treating “closed” and “open” system flavored e-cigarette products the same, did not constitute a change in policy.

The Court remanded the case to the Fifth Circuit to determine whether FDA had engaged in harmless error when it abandoned a prior requirement that manufacturers submit its marketing plans for their products.

The Court’s decision marks an end to the circuit split caused by the Fifth Circuit’s en banc panel on this specific issue, but we fully expect continued litigation and regulation over this hot topic.  We will continue to monitor these developments as they unfold.

Hyman, Phelps & McNamara (HPM) marks its 45th Anniversary year by welcoming three accomplished professionals who reinforce the depth and breadth of the firm’s FDA and DEA practices.

• Naomi Lowy joins HPM as a Principal Drug Regulatory Expert after 18 years at the FDA’s Center for Drug Evaluation and Research (CDER), most recently as the Deputy Director, Division of General Endocrinology. Dr. Lowy previously served as the Deputy Director, Division of Anesthesiology, Addition and Pain Medicine and the Associate Director for Regulatory Science, Office of Drug Evaluation 1, CDER.
• Andrew Hull rejoins the firm as a Director after 6 years as an Assistant United States Attorney in the Western District of Michigan.
• Julie Kim joins the firm as an Associate.

“In 1980, we set out to create a world-class law firm focused on FDA, and 45 years later, Naomi, Andrew and Julie continue that tradition,” said HPM founder Paul Hyman.

“Naomi’s insights and experience will solidify an already strong team of lawyers and regulatory experts helping our clients navigate the drug approval process,” noted Director James Valentine.  “We are excited by Naomi’s strong passion for solving complex regulatory issues and ensuring patient stakeholders have a voice in the drug development process.” For nearly two decades, Dr. Lowy provided leadership across a range of important therapeutic areas, including general endocrinology, pain/opioids, cardiology, neurology, and psychiatry. In her distinguished FDA career, Dr. Lowy provided thought leadership in drug policy and product development for rare endocrinologic diseases, opioids, sarcopenia, and cancer cachexia. She also has extensive experience in advisory committee preparation, authored numerous Guidances for Industry, and co-developed the current drug review process and template.

Andrew Hull brings his expertise to the firm’s enforcement, compliance, and litigation practice. Director Karla L. Palmer, commented.  “Andrew was a highly skilled, tenacious, and sought-after associate at the firm, working on DEA regulatory and litigation matters as well as internal investigations involving FDA-regulated products.  We were sad when he left to gain valued experience as a federal prosecutor but are absolutely thrilled and honored to welcome him back.”  Andrew draws on his government experience investigating and prosecuting violations of the FDC Act, the Controlled Substances Act, the False Claims Act, and other federal healthcare laws to now represent clients facing those issues.

Julie Kim’s 2022 law school graduation year belies her experience.  Julie joins HPM after working at an intellectual property law firm, where she prosecuted and counseled clients on patent portfolios in the medical device and biotechnology sectors.  During law school, Julie obtained practical litigation and transactional experience.  Before her legal career, Julie worked as a nurse practitioner specializing in neurosurgery and infectious diseases.  “Julie brings the type of energy and commitment to projects that has made HPM successful.  We look forward to her development and future success here,” said HPM Managing Director J.P. Ellison.

Last June, the United States Supreme Court issued four landmark decisions that curbed executive agency powers. Those decisions are changing the way agencies, including FDA, exercise their rulemaking and enforcement authorities. Regardless of your position on the correctness of the holdings or the reasoning behind them, Loper Bright, Jarkesy, EPA v. Ohio, and Corner Post have fundamentally altered the scope of agency authority. Last week, the U.S. Supreme Court heard oral arguments in a combined case that may add a fifth decision to the starting lineup of how we discuss agency limits—or, at least, litigation about agency limits—going forward.

FCC v. Consumers’ Research, consolidated with SHLB Coalition v. Consumers’ Research is a challenge concerning a constitutional legal principle called the nondelegation doctrine. According to its advocates, Congress cannot constitutionally delegate its authority to executive branch agencies without clear guidelines and limits. It’s born of Article I, Section 1, “All legislative Powers herein granted shall be vested in a Congress of the United States, which shall consist of a Senate and House of Representatives.” “All” means all, according to the doctrine’s advocates, and courts should view delegations with extreme prejudice, especially those dealing with the collection of money. Absent an “intelligible principle to which the person or body authorized to” act, the judiciary should forbid delegation. The precedent requiring an intelligible principle for delegation is almost a century old and little used, but legal groups are trying to revive it.

Here, Congress has charged the FCC with collecting fees from voice service providers to fund a nonprofit corporation that, in turn, subsidizes phone and internet services in underserved rural areas. The respondents challenged that law in several federal suits around the county, claiming it’s akin to an unconstitutional tax. The case comes to the Supreme Court after Consumers Research lost before panels in the Fifth, Sixth, and Eleventh Circuits. A win before an en banc rehearing in the Fifth Circuit provided the split needed to move their case to SCOTUS.

We note that in Loper Bright, SCOTUS overturned the Chevron doctrine in part because it ruled that the National Marine Fisheries Service lacked the Constitutional authority to impose financial burdens on fishing vessels. In Jarkesy, SCOTUS ruled that the SEC lacked the Constitutional authority to impose civil penalties on defendants absent a jury trial. Both arose from executive agencies collecting money. That common thread makes for a stronger challenge because taxation and revenue are not traditionally executive branch functions. To that point, last week’s oral argument focused largely on the manner in which FCC raised funds for the nonprofit at the center of the case, and how those funds were managed.

If SCOTUS brings back the nondelegation doctrine, perhaps the Court will limit its ruling to how agencies collect funds. That potentially implicates FDA’s user fee programs. As of now, though, it’s too soon to know if the Court would stop there, or if broader challenges are afoot. Either way, a revival of the nondelegation doctrine potentially introduces a number of constitutional issues for FDA, adding yet another limiting layer on agency authority. Loper Bright throttled how agencies like FDA can interpret their regulatory power; Consumers’ Research potentially allows future litigants to question whether they should even have the power in question in the first place.

Like FCC, FDA relies on broad statutory authority from Congress under a unique statute. The scientific and policy issues within FDA’s jurisdiction have long been thought of as so complex that delegations to FDA and other federal agencies were necessary to protect public safety. But combined with end of agency deference, the resurrection of the nondelegation doctrine may add another aspect to the shift in oversight we are navigating as a country.

We’ll have another post in June, after the decision is handed down.

That’s a play on an old acronym, in service of a point. A few weeks ago, HHS released a press release stating that FDA had been directed “to explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and related guidance to eliminate the self-affirmed GRAS pathway.” That seems like an unenviable task in light of the clear language of the statute and the agency’s prior concessions that it lacks explicit authority to require premarket approval or even notification of GRAS status.

Under § 201(s) of the Federal Food, Drug, and Cosmetic Act, GRAS is a state of being, based on expert consensus or on common use in food prior to January 1, 1958, not a status conferred by FDA.  If you never got around to reading Center for Food Safety v. Becerra, now would be a good time to catch up. In that pre-Loper Bright case, FDA successfully defended its 2016 GRAS final rule. FDA and the court agreed that “the law does not require manufacturers to get preapproval before using a substance the manufacturer believes to be GRAS.” Instead, FDA has the power to take enforcement action if it does not agree with a person’s GRAS determination. Some highlights from the opinion are quoted below (citations and internal quotations omitted):

• As the Government correctly points out, the FDCA does not impose mandatory GRAS notification on manufacturers or require FDA to review industry GRAS conclusions in advance of marketing.
• The Government argues that the FDCA is silent on whether the manufacturer must notify FDA of GRAS conclusions.
• [A]s amicus curiae SFIC points out in its brief, FDA has a long-standing record of interpreting the FDCA to exempt GRAS substances from premarket review. Indeed, the system in place before the GRAS Rule was also voluntary. Similarly, as the Government notes, Congress has amended the Food Additives Amendment but has never amended the language to require mandatory GRAS submissions.
• Plaintiffs argue that the statutory text specifically speaks on the issue because the Food Additives Amendment requires that in order to determine whether a food additive is safe, the FDA shall consider … the cumulative effect of such additive in the diet of man or animals, taking into account any chemically or pharmacologically related substance or substances in such diet, and the FDA cannot make this determination without information about current exposures to substances already present in food. Plaintiffs’ strained interpretation is unpersuasive—this language does not have an unambiguous meaning; it is dubious to think that Congress used such language to require manufacturers to inform FDA of GRAS determinations without explicitly saying so. Congress does not, one might say, hide elephants in mouseholes.

The court ultimately sided with FDA, based in part on a Chevron analysis that somehow proceeded to step two, at which the court deferred to FDA’s interpretation of the statute as reasonable. Cue Loper Bright, which we’ve blogged about here and here. Under the standard of review articulated in that decision, one can reasonably wonder how a regulation to eliminate GRAS self-affirmation could survive judicial review, given the underlying statutory text and the government’s concessions highlighted above.

In short, GRAS looks like it’s here to stay, absent an amendment to the FD&C Act. Pressure for such an amendment is building, in part because states are considering jumping into the fray (see, e.g., New York’s Senate Bill S1239A a/k/a the Food Safety and Chemical Disclosure Act, which would require reporting of GRAS substances). As they say, be careful what you wish for. Among the merits of the existing framework is its efficiency, and that merit now looms larger than ever. As the HFP continues to bleed personnel, it will become even harder for the program to maintain its core functions, let alone take on new ones.

Last week, U.S. Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) announced the introduction of two bills we’ve seen before: (1) S. 1096, the Preserve Access to Affordable Generics and Biosimilars Act; and (2) S. 1095, the Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (“Stop STALLING Act”).  While the focus of this post is S. 1096, we note that S. 1095 would authorize the Federal Trade Commission (“FTC”) to initiate a civil action against any person or entity that submits a baseless petition to FDA with the intent that the Agency’s review of the petition would delay the approval of a generic drug, a biosimilar biological product, or certain other new drugs (see here).

As we’ve discussed previously, the Preserve Access to Affordable Generics and Biosimilars Act, which addresses drug and biological product patent settlement agreements, has been floating around Congress in some form for about 20 years – since well before the U.S. Supreme Court declined to hold, in FTC v. Actavis, Inc., 133 S. Ct. 2233 (2013), that so-called reverse payment settlement agreements are presumptively unlawful.

The latest iteration of the bill would, like prior versions, amend the FTC Act to add new Section 27.  The latest iteration of proposed Section 27 in S. 1096 says that “[i]t shall be a violation of this section for a party to enter into, or be a participant to, an agreement, resolving or settling, on a final or interim basis, a patent claim in connection  with the sale of a drug product or biological product, that has anticompetitive effects,” and that an agreement “shall be presumed to have anticompetitive effects” if:

(i) an ANDA filer or a biosimilar biological product application filer receives anything of value, including an exclusive license; and

(ii) the ANDA filer or biosimilar biological product application filer agrees to limit or forgo research, development, manufacturing, marketing, or sales of the ANDA product or biosimilar biological product, as applicable, for any period of time.

And, as in prior versions there are, of course, some narrow exceptions and exclusions:

[I]f the parties to such agreement demonstrate by a preponderance of the evidence that—

(i) the value described in subparagraph (A)(i) is compensation solely for other goods or services that the ANDA filer or biosimilar biological product application filer has promised to provide; or

(ii) the procompetitive benefits of the transfer of value described in subparagraph (A)(i) and the agreement by the ANDA filer or biosimilar biological product application filer to limit or forgo research, development, manufacturing, marketing, or sales of the ANDA product or biosimilar biological product described in subparagraph (A)(ii) outweigh the anticompetitive effects of the transfer of value described in subparagraph (A)(i) and the agreement by the ANDA filer or biosimilar biological product application filer to limit or forgo research, development, manufacturing, marketing, or sales of the ANDA product  or biosimilar biological product described in subparagraph (A)(ii).

In addition, proposed Section 27 would not “prohibit a resolution or settlement of a patent infringement claim in which the consideration that the ANDA filer or biosimilar biological product application filer, respectively, receives as part of the resolution or settlement includes only one or more of” the items listed in the bill (e.g., payment of reasonable litigation expenses).

But then come the newly revised penalties provisions:

(4) CIVIL ACTION.—In addition to any proceeding under section 5, if the Commission has reason to believe that a party has violated this section, the Commission may bring, in its own name by any of its attorneys designated by it for such purpose, a  civil action against the party in a district court of the United States to seek to recover any of the remedies of civil penalty, mandatory injunctions, and such other and further equitable relief as the court deems appropriate.

(5) CIVIL PENALTY.—

(A) IN GENERAL.—Each party that violates or assists in the violation of paragraph (1) shall forfeit and pay to the United States a civil penalty sufficient to deter violations of paragraph (1), but in no event greater than 3 times the value received by the party that is reasonably attributable to the violation of paragraph  (1). If no such value has been received by the NDA holder, the biological product license holder, the ANDA filer, or the biosimilar biological product application filer, the penalty to the NDA holder, the biological product license holder, the ANDA filer, or the biosimilar biological product application filer shall be sufficient to deter violations, but in no event shall be greater than 3 times the value given to an ANDA filer or biosimilar biological product application filer reasonably attributable to the violation of this section.

(B) AMOUNT.—In determining the amount of the civil penalty described in subparagraph (A), the court shall take into account—

(i) the nature, circumstances, extent, and gravity of the violation;

(ii) with respect to the violator, the degree of culpability, any history of prior such conduct, including other agreements resolving or settling a patent infringement claim, the ability to pay, any effect on the ability to continue doing business, profits earned by the NDA holder, the biological product license holder, the ANDA filer, or the biosimilar biological product application filer, compensation received by the ANDA filer or biosimilar biological product application filer, and the amount of commerce affected; and

(iii) other matters that justice requires.

(C) REMEDIES IN ADDITION.—Remedies provided in this paragraph are in addition to, and not in lieu of, any other remedy provided by Federal law. Nothing in this section shall be construed to limit any authority of the Commission under any other provision of law.

These penalty provisions, like the penalty provisions we commented on in the 2024 version of the Preserve Access to Affordable Generics and Biosimilars Act, raise some pretty significant concerns in light of the U.S. Supreme Court’s decision in SEC v. Jarkesy, 144 S. Ct. 2117 (2024) (see our previous post here), as well as a recent Executive Order (EO 14215), titled “Ensuring Accountability for All Agencies.”  Let us count the ways . . . .

First, S. 1096 has some pretty significant Constiutionality concerns. The bill allows the FTC to proceed before an Administrative Law Judge, a process that implicates both the separation of powers and the Seventh Amendment.

In Jarkesy, the U.S. Supreme Court reemphasized that the Seventh Amendment to the U.S. Consitution protects the right to a jury trial in federal court.  That right extends to clams enforced by federal agencies, such as FTC.  Under the Seventh Amendment and Jarkesy, a jury trial must be provided on liability before civil monetary penalties that are legal in nature can be assessed.  S. 1096 permits the FTC to seek civil monetary penalties for purportedly anticompetitive patent settlements.  Those penalties are clearly legal in nature—and therefore trigger the Seventh Amendment under Jarkesy—because they are punitive treble penalties.  Further, S. 1096 specifically permits the FTC to continue to use its administrative process to determine that a company has violated the new rules on settlements.  When the FTC uses its administrative process, it is acting as the investigative body, prosecutor, administrative judge, and appellate body.  Under current law, the FTC Commissioners and its ALJs are insulated by statute from presidential removal, raising separation of powers concerns that are currently being litigated in the courts.  And whatever the outcome of those challenges, the use of the ALJ process to determine liability for civil penalties is plainly not permitted under Jarkesy.

S. 1096 contemplates that the FTC will file a civil action in district court.  But that process is still problematic constitutionally if it denies a right to a jury trial, especially if it comes after liability has been determined against the same company in an ALJ proceeding.  Indeed, S. 1096 does not mention a jury trial anywhere, and instead expressly assigns a number of findings to the judge in a bench trial.  It’s not unreasonable to assume that the FTC would oppose any request for jury trial given this language.

Second, S. 1096 contradicts EO 14215 by permitting the FTC to seek civil monetary penalties without sign-off by the U.S Attorney General (“USAG”).   EO 14215 requires employees of agencies, like the FTC, to consult with the USAG on interpretations of the law and removes any agency authority to advance its own legal positions without consultation.  The Department of Justice (“DOJ”) has an existing referral process whereby the FTC must first consult with the USAG before filing a case in federal court for civil penalties.  But despite EO 14215 and the existing referral process, S. 1096  permits the FTC to unilaterally proceed without consultation with DOJ or the USAG.  It also permits the FTC to sue using its own attorneys rather than DOJ attorneys, again in direct conflict with EO 14215.  (As an aside, this also raises separation of powers and constitutionality concerns because it allows penalties to be imposed by commissioners who are neither fully answerable to the President nor shielded from outside influence.)

Third, S. 1096 imposes an irrebuttable presumption that will likely severely chill procompetitive patent settlement agreements.  In Actavis, the FTC argued that pharmaceutical settlements should be subject to a presumption of anticompetitive effect.  The Supreme Court directly rejected the FTC’s argument, stating that “[t]he FTC urges us to hold that reverse payment settlement agreements are presumptively unlawful and that courts reviewing such agreements should proceed via a “quick look” approach, rather than applying a ‘rule of reason.’ . . . We decline to do so.”  But despite the U.S. Supreme Court’s rejection of a presumption, S. 1096 now includes a seemingly irrebuttable presumption.  Indeed, rather than looking at a patent settlement agreement as a whole in assessing procompetitive benefits, S. 1096 requires examining the procompetitive benefits of the “transfer of value” and the “agreement to limit or forgo” marketing.  No court has ever adopted this interpretation of patent settlements, and the U.S. Court of Appeals for the Fifth Circuit declined such an interpretation in 2021 in Impax Laboratories, Inc. v. FTC, 994 F.3d 484 (5th Cir. 2021).  By ignoring the patent settlement agreement as a whole, S. 1096 severely disincentivizes procompetitive patent settlements that include numerous procompetitive features, including waivers of regulatory exclusivity, that will now be ignored under the balancing test.

Fourth, S. 1096 contradicts longstanding statutory authority on the statute of limitations for civil monetary penalties.  Under 28 U.S.C. § 2462, the statute of limitations for civil monetary penalties is five years from the occurrence of the penalized conduct.  But S. 1096 imposes a new and longer statute of limitations for patent settlements.

Fifth, S. 1096 would significantly expand the universe of affected parties.  Here’s what the bill from the last Congress stated: “The Commission may initiate a proceeding to enforce the provisions of this section against the parties to any agreement resolving or settling, on a final or interim basis, a patent claim, in connection with the sale of a drug product or biological product” (emphasis added).  But the new version goes further: “It shall be a violation of this section for a party to enter into, or be a participant to, an agreement, resolving or settling, on a final or interim basis, a patent claim in connection  with the sale of a drug product or biological product, that has anticompetitive effects” (emphasis added).  That potentially creates personal liability and is not unlike California’s Preserving Access to Affordable Drugs law that respect.

Although we imagine that sponsors and co-sponsors of S. 1096 will continue to press on for passage of the legislation, the flaws above seem fatal to implementing any new Section 27 of the FTC Act.

Trade and national press have reported that recent changes in FDA staffing levels have already led to  slower responses to calls and emails.  According to reports, which were published before the most recent reports of HHS staff level reductions and tumultuous changes in leadership, FDA staff were missing minor deadlines.  This coupled with more recent reports raised the specter of FDA falling short of user fee goals.

Although reviews teams’ workload has not decreased, resources have. FDA leadership will inevitably need to make some difficult choices, including internal guidance on which assignments teams should prioritize and which can be temporarily or indefinitely delayed, or completely shelved.

A less robust schedule of external meetings and slower pace of publications of Guidance to Industry may further slow communication to sponsors who eagerly await information critical to inform their development programs.

While it may be hard to see the upside to less information from FDA, Albert Einstein famously stated, “In the middle of difficulty lies opportunity.”  As FDA itself navigates through turbulent times, companies will need to anticipate potential issues with what may be less direct, thorough, and prompt feedback from FDA. Just as important will be the need to respond expertly, efficiently and meaningfully to FDA concerns. Therein lies the opportunity.

While much may be in flux, the central tenet of drug development remains the same, develop drugs that are safe and effective drugs for patients, through streamlined, efficient, and cost-effective development programs. Key to achieving those goals is the ability to anticipate FDA feedback and concerns.

As we continue to closely follow inevitable additional changes, sponsors should consider how to best anticipate and adapt. Patients and their families are counting on it.