The Food and Drug Law Institute (“FDLI”) will host an intensive one-day, must-attend conference on June 24, 2011, at the Westin City Center in Washington, DC, titled “Brands, Generics and Hatch-Waxman: New Challenges; Unabated Controversy.”  The conference will cover myriad Hatch-Waxman issues, including 180-Day Exclusivity, New Drug Application Exclusivities and Patent Term Extensions, Patent Certification/Litigation, and Regulatory Strategies and Conundrums, and boasts a virtual who’s who of presenters from the Hatch-Waxman legal community.  Among other presenters are FDA’s Elizabeth H. Dickinson, Associate Chief Counsel for Drugs, Office of the Commissioner, Caroline Holland, Chief Counsel and Staff Director, Subcommittee on Antitrust, Competition Policy, and Consumer Rights, Judiciary Committee, U.S. Senate, and C. Scott Hemphill, Professor of Law, Columbia Law School.

According to the program description:

The constant array of lawsuits, petitions, and administrative challenges regarding 180-day exclusivity, patent listings, and patent-term extensions have addressed important issues during the last year, resolving some but further complicating others.  This program will provide an in-depth analysis of these ongoing issues.  The Program will also address antitrust considerations associated with Hatch-Waxman patent and administrative challenges and the interplay between Hatch-Waxman and the newly authorized biosimilars approval pathway.

Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst, a member of the conference planning committee, is a speaker on the 180-Day Exclusivity panel.  Others on that panel moderated by David G. Adams, Partner, Chairman, FDA Group, Venable LLP, are Ms. Dickinson, Mr. Hemphill, and Michael D. Shumsky, Partner, Kirkland & Ellis LLP.

You can register for the event on FDLI’s website here, or by contacting FDLI’s Customer Service at (202) 371-1420.  We look forward to seeing you at the conference.

By Nisha P. Shah & Kurt R. Karst –

The U.S. Government Accountability Office (“GAO”) recently issued a report required by the FDA Amendments Act of 2007 (“FDAAA”) concerning the effects of the Pediatric Research Equity Act (“PREA”) (FDC Act § 505B) and the Best Pharmaceuticals for Children Act (“BPCA”) (FDC Act § 505A) on the study and labeling of drug and biological products for pediatric use.   The GAO found that at least 130 products (80 products under PREA and 50 under the BPCA) have been studied for use in children since FDAAA’s enactment on September 27, 2007.  Despite this success, the GAO says in its report that “FDA lacks an important internal control that would allow it to manage its review process to ensure that the agency and sponsors are meeting the law’s requirements and that FDA is meeting its own mission, goals, and objectives during the period of its review of the application.”

The BPCA and PREA are sometimes referred to as the “carrot and stick” approach to obtaining pediatric labeling.  PREA (the stick) requires sponsors to conduct pediatric studies in various pediatric age groups for certain drug and biological products, and to submit the results and proposed labeling changes to FDA with a marketing application.  FDA may waive (partially or fully) the PREA requirement or defer the submission pediatric study results until after product approval.  Under the BPCA (the carrot), FDA issues a written request to a sponsor to conduct pediatric studies for products that may have important health benefits in children.  A sponsor can decline FDA’s request; however, if the sponsor completed the requested studies, FDA grants six months of marketing exclusivity for the drug or biological product.  Additionally, a sponsor can request that a product that must be studied under PREA to be studied also under the BPCA to allow the sponsor to be eligible for six-months of  pediatric exclusivity. 

For drugs approved under the FDC Act, pediatric exclusivity attaches to any unexpired patent and non-patent marketing exclusivities listed in the Orange Book for any of the sponsor’s approved drug products (including certain combination products) that contain the active moiety for which pediatric exclusivity was granted.  For biological products licensed under the PHS Act, pediatric exclusivity extends by six months the 12- and 4-year reference product exclusivity periods described at PHS Act § 351(k)(7).  Pediatric exclusivity also extends by six months the 7-year period of orphan drug exclusivity applicable to a biological product.  For both drug and biological products, the law contains a similar exception with respect to the applicability of pediatric exclusivity.  Specifically, for post-September 2007 written requests, pediatric exclusivity will not apply to a particular period of patent or non-patent exclusivity if FDA grants pediatric exclusivity “later than 9 months prior to the expiration of such period.” 

According to the GAO report, FDA claimed that about 830 applications subject to PREA were submitted to FDA from September 27, 2007 to June 30, 2010, but FDA could not provide an exact number.  The Pediatric Review Committee (“PeRC”), a FDA committee responsible for assisting in the review of pediatric study results, completed reviews for 449 applications, 80 of which contained the results of pediatric studies (59 were drug applications and 21 were biological product applications).  The GAO claims that FDA could not provide information on the remaining 381 applications.  The GAO also found that FDA granted a full or partial waiver or deferral to more than half of the applications it received under PREA (237 waivers and 131 deferrals).  Under the BPCA, 50 products have been studied between the 2007 reauthorization through June 30, 2010, all of which were for drug products.  According to FDA officials, FDA granted pediatric exclusivity to 44 of the 50 drugs.  The report indicated that sponsors for five of the six drugs that did not receive exclusivity submitted only partial responses to FDA’s requests. 

Since the 2007 reauthorization of PREA and the BPCA, all of the 130 drug and biological products with studies completed and applications reviewed by FDA had labeling changes.  In comparison, in the prior nine years, 256 products had pediatric study-related labeling changes agreed upon by FDA and the sponsor.  According to the report, the top three categories of labeling changes are: (1) expansion of pediatric age groups approved in the label, (2) safety and effectiveness were not established in pediatric populations and a description of the study conducted was added, and (3) new and enhanced pediatric safety information was included. 

The GAO interviewed stakeholders, including drug and biological product sponsors, concerning challenges to conducting pediatric studies, which include:

• “confusion about how to comply with PREA and BPCA due to a lack of current guidance from FDA … [since] the most recent PREA guidance is draft guidance from 2005 and that the most recent BPCA guidance was revised in 1999;”
• “since PREA and BPCA are subject to reauthorization every 5 years, some of the statutory requirements for studies could change while studies are under way or as they are being planned; therefore, there is uncertainty as to the requirements that will apply when they conduct the studies;”
• “complying simultaneously with … PREA and BPCA, and the [EU] Paediatric Regulation;” and
• “the lack of economic incentives presents a challenge to sponsors’ willingness to conduct pediatric studies voluntarily, as under BPCA,” particularly for products that are nearing the end of their market exclusivity or are off-patent because of the lack of economic benefit associated with conducting pediatric studies.  This is because once a drug or biological product is off-patent, the sponsor cannot receive pediatric exclusivity for conducting such studies. 

The GAO recommended that FDA implement a system “to track applications upon their submission and throughout its review process and maintain aggregate data, including the total number of applications that are subject to PREA and whether those applications include pediatric studies.”  HHS officials stated that an update to a tracking system, which was completed in May 2011, will allow FDA to track applications subject to PREA.  Although the GAO acknowledged the benefits of an improved tracking system, the GAO also responded that it was unclear whether the data system would allow FDA to track and aggregate data about applications that are currently under review.

Separate from the GAO report, the Institute of Medicine (“IOM”) has convened an ad hoc committee to examine pediatric studies conducted under the BPCA and PREA.  Among other things, the committee is reviewing and assessing a representative sample of PREA and BPCA studies and related labeling changes, and is supposed to issue a report offering “recommendations for ensuring pediatric testing of biological products.”

ADDITIONAL READING:

• FDA Pediatric Drug Development Website
• PhRMA Statement on Tremendous Success of BPCA and PREA
• IOM Meeting Materials on Pediatric Studies Conducted under the BPCA and PREA

By Carmelina G. Allis –

The “Menaflex” is a collagen meniscus implant intended to reinforce damaged meniscal soft tissue.  ReGen Biologics, Inc. obtained 510(k) clearance for the Menaflex in 2008 as a Class II device.  On March 30, 2011, FDA rescinded this clearance.  Last week, ReGen filed suit based upon the theory that FDA lacks authority under the Food, Drug, and Cosmetic Act (“FDCA”) to rescind a 510(k) clearance.  ReGen seeks a declaratory judgment that the Menaflex may be legally marketed in the U.S. as a Class II device.  The lawsuit was brought in the U.S. District Court for the District of Columbia and follows a petition ReGen filed last month with the U.S. Court of Appeals for the District of Columbia Circuit – see our previous post here – seeking review of the March 30, 2011 order.  ReGen has presumably filed two lawsuits to eliminate any argument by the government that the suit was filed in the wrong court.  Over the years, FDA has challenged suits filed in district courts or alternatively in a court of appeals by claiming that the plaintiff sued in the wrong court.  Filing in both courts, as ReGen did, should eliminate that potential argument in one of the courts.

The review of ReGen’s Menaflex 510(k) resulted from allegations that the agency’s review of the submission had departed from “FDA processes, procedures and practices.” Those allegations apparently stemmed, in part, from documents sent to U.S. Congressmen by FDA reviewers that raised questions about the integrity of the 510(k) review process for the Menaflex device.

In October 2010, FDA rescinded the 510(k) substantial equivalence determination alleging that the device does not have the same intended use as predicate surgical meshes.  ReGen’s complaint alleges that the agency’s determination is inconsistent with the findings of two Advisory Panels, and contrary to the conclusions of Dr. Daniel Schultz, the CDRH Director who granted 510(k) clearance.  The product is now subject to the more burdensome Class III, premarket application (“PMA”) approval requirements.

According to the complaint, counsel for the company asked FDA counsel “to identify the statutory or regulatory basis” for the rescission order, to which agency counsel declined to answer “stating that disclosure of the statutory basis for the order would be the equivalent of providing ‘legal advice,’ and that it is FDA’s policy not do so.”

The complaint alleges that FDA’s actions forced the company into bankruptcy, and have “create[d] substantial uncertainty in the device industry because the FDA could decide to revisit other products that were legally classified through the 510(k) premarket notification process without observing lawful processes.”

FDA has not yet responded to the complaint.  FDA has always asserted that the FDCA grants the agency authority to rescind 510(k)s, but that interpretation is not explicitly provided in the FDCA.  In contrast, there is a provision expressly granting FDA authority to withdraw a PMA approval (section 515).  FDA also has authority to ban devices that are unsafe (section 516) or to reclassify a device from Class II to Class III if information emerges that warrants reclassification (section 513).  FDA did not invoke those explicit procedures in this case.  The agency issued a proposed rule setting forth a procedure for rescission in 2001, but it was never finalized. 

It may be true that at least one court has ruled that FDA has implicit statutory authority generally claimed by administrative agencies to undo a decision based upon outright fraud or clear administrative error.  But the ReGen case seems to involve rescission of a 510(k) because a new set of agency officials arrived at a different judgment than their predecessors.

By Jamie K. Wolszon & Jeffrey N. Gibbs –

FDA has issued a draft guidance that would limit the sale and distribution of “Research Use Only” (RUO) and “Investigational Use Only” (IUO) products.  (A copy of the Federal Register notice announcing the guidance is available here.) While most of the restrictions set out in the policy are consistent with the current practices of many companies, in several key areas the agency’s proposals would substantially curb the sale of RUO and IUO labeled products. 

Most significantly, FDA has departed from the well-established practice of determining intended use based on the manufacturer’s conduct, rather than how a customer uses a product.  FDA states in the draft guidance that a manufacturer must stop sales of its RUO or IUO product to a customer once the manufacturer knows – “or has reason to know” – that the customer is using the product for a diagnostic use, even if the manufacturer makes no diagnostic claims or statements. 

Long-standing Requirements for both RUOs and IUOs Retained
 
Several of the basic requirements to qualify as an RUO or an IUO have not changed.  To be IUO, all labeling for “a product being shipped or delivered for product testing prior to full commercial marketing (for example, for use on specimens derived from humans to compare the usefulness of the product with other products or procedures which are in current use or recognized as useful)” must bear the statement, prominently placed: “For Investigational Use Only. The performance characteristics of this product have not been established.’’

Meanwhile, to be RUO, product must be in the laboratory research phase of development, and not represented as an effective in vitro diagnostic product.  In addition, all labeling must bear the statement, prominently placed: “For Research Use Only. Not for use in diagnostic procedures.’’

The existing regulation has left the category “RUO” ill-defined.  In the draft guidance, FDA explains that “the focus of manufacturer-initiated studies is typically to evaluate design, limited-scale performance, and issues such as usability of the test.” FDA provided the following examples of RUO products:

• Tests that are in development to identify test kit methodology, necessary components, and analytes to be measured;
• Instrumentation or other electrical/mechanical components under development to determine correct settings, subcomponents, subassemblies, basic operational characteristics, and possible use methods;
• Reagents under development to determine production methods, purification
  levels, packaging needs, shelf and storage life, etc.

FDA also recognizes that products “intended for use in non-clinical laboratory research with goals unrelated to development of a commercial product, such as discovering and developing novel and fundamental medical knowledge related to human disease and conditions,” (emphasis added) could qualify as RUO. The guidance provides as examples “instruments and reagents intended for use in research attempting to isolate a gene linked with a particular disease when such instruments and reagents are not intended to produce results for clinical use.”

This is a narrower interpretation of “research” than is commonly understood.  It is not clear what is FDA’s basis in confining the category of research products to ones used to advance “novel and fundamental” objectives.  It is clear that this limitation will be both difficult to apply and controversial.

Defining Intended Use Based on Actual Use
 
FDA states that in determining whether a product is properly marketed as RUO or IUO, it will consider the manufacturer’s statements and claims about its product.  This is a well-established regulatory principle.  However, FDA also said it would consider the manufacturer’s knowledge of the customer’s intended use.

FDA may consider a manufacturer’s knowledge of the purposes for which its customers offer and use its IVD product, and the manufacturer’s provision of technical support for those activities, to be evidence that the IVD product is intended to be used for such purposes. The weight of this evidence will vary with the circumstances.

Specifically, in addition to promotion by the manufacturer, FDA says it will consider the following factors as indicating that a device is not RUO or IUO:

• “[S]tatements in any labeling, advertising, or promotion of the IVD product that suggest that clinical laboratories can validate the test through their own investigational procedures and subsequently offer it for clinical diagnostic use as a laboratory developed test;” 
• “Sales to clinical laboratories that the manufacturer knows, or has reason to know, use the IVD product in clinical diagnostic use in an investigation or otherwise, and support (including technical support) for those activities.” 
• assistance “in the validation or verification of the performance of a test that the manufacturer know is used in clinical diagnosis.”

FDA also advises manufacturers of products labeled as RUO or IUO that if they discover that a clinical laboratory to which it sells its IUO or RUO device is using these IUO or RUO labeled products for a non-investigational diagnostic use, “it should halt sales for such use or comply with FDA regulations for IVD products, including premarket review requirements.”  (Emphasis added).  This position that a company should discontinue sales to a customer because that customer is using the product in a manner outside the labeling may be unprecedented.  Significantly, the draft guidance includes no provision for manufacturers first to inform the customer that it must stop diagnostic use or take other measures to alter the manner of usage.  Rather, FDA is apparently saying that the manufacturer has no option but to cease sales immediately.

Import of RUOs

Although IVD products intended solely for research use are generally exempt from most regulatory requirements, foreign manufacturers who import RUO IVD products into the U.S. are not specifically exempt from establishment registration and device listing requirements. FDA states in the guidance that it intends to exercise enforcement discretion “with respect to establishment registration and device listing requirements for persons who manufacture, propagate, compound, or process imported IVD products intended solely for research use.”  The agency has established specific codes to use for import of RUO products.  This information will provide FDA with more specific insights into which RUO products are being imported.

Many aspects of the draft guidance are not surprising, and are consistent with the practices adopted by many companies.  However, FDA’s stance that RUO and IUO manufacturers must “halt” sales to a customer because its use of an RUO or IUO product for diagnosis is a major departure.  Moreover, FDA’s reliance on customer conduct to define intended use has implications for other products beyond those labeled RUO and IUO, by determining intended use through customer behavior, not manufacturer’s conduct.  In addition, the narrowed definition of RUO will be both difficult to apply and likely have unintended negative consequences.

Comments to this proposed draft guidance are due by August 30, 2011.

By Kurt R. Karst –      

Last week, in a seven-page response, FDA denied an October 18, 2010 Citizen Petition submitted on behalf of Lupin Limited (“Lupin”) requesting that FDA determine that Teva Pharmaceuticals USA, Inc.’s (“Teva’s”) ANDA No. 79-081 for a generic version of COMBIVIR (lamivudine and zidovudine) Capsules, and that contains the first Paragraph IV certification to an Orange Book-listed patent on the Reference Listed Drug (“RLD”), is not eligible for 180-day exclusivity.  In its response, FDA affirms that the plain language of the definition of a “first applicant” at FDC Act § 505(j)(5)(B)(iv)(II)(bb) as added by the 2003 Medicare Modernization Act (“MMA”) simply requires a Paragraph IV certification, regardless of what Orange Book-listed patent that certification concerns. 

COMBIVIR is listed in the Orange Book with two unexpired patents – U.S. Patent No. 5,859,021 (“the ‘021 Patent”), which expires on May 15, 2012, and U.S. Patent No. 5,905,082 (“the ‘082 Patent”), which expires on May 18, 2016 and is subject to a period of pediatric exclusivity that expires on November 18, 2016.  Teva submitted ANDA No. 79-081 to FDA on June 26, 2007 containing a Paragraph IV certification to the earlier-expiring ‘021 Patent, and a Paragraph III certification to the later-expiring ‘082 Patent.  In October 2008, Teva reportedly amended its ANDA to contain a Paragraph IV certification to the ‘082 Patent.  In the meantime, Lupin submitted an ANDA in January 2008 containing Paragraph IV certifications to both the ‘021 and ‘082 patents. 

Under the FDC Act as amended by the MMA, a “first applicant” qualifies for 180-day exclusivity.  The term “first applicant” is defined as “an applicant that, on the first day on which a substantially complete application containing a [Paragraph IV certification] is submitted for approval of a drug, submits a substantially complete application that contains and lawfully maintains a [Paragraph IV certification] for the drug.”  Lupin argues in its Citizen Petition that Teva is “not a lawful ‘first applicant’” based on its Paragraph IV certification to the earlier-expiring ‘021 Patent.   Instead, Lupin says that it is the correct “first applicant” based on its Paragraph IV certification to the later-expiring ‘082 Patent.  FDA’s petition response boils Lupin’s Citizen Petition arguments down to the following: “According to Petitioner, Teva fails to qualify as a first applicant because its ANDA (1) cannot be considered to have contained a valid paragraph IV certification, (2) cannot be considered to have been substantially complete, and (3) cannot be considered to have lawfully maintained a paragraph IV certification.”

Hewing close to the statutory language, FDA reasons in its petition response that:

Regardless of Teva’s reason for initially challenging only the ‘021 patent, its paragraph IV certification to that patent qualified it for exclusivity.  The statute provides that an applicant submitting a paragraph IV certification will be a “first applicant” (i.e., eligible for exclusivity) if on the first day any applicant submits a substantially complete application containing a paragraph IV certification, the applicant “submits a substantially complete application that contains and lawfully maintains a [paragraph IV certification]” (section 505(j)(5)(B)(iv)(II)(bb) of the Act (emphasis added)).  The plain language of the MMA requires “a” certification; it does not require a first applicant to be the first to challenge with a paragraph IV certification more than a single patent or even the latest expiring patent.  If Teva was the first to file a paragraph IV patent certification for a listed patent for Combivir (and otherwise meets the statutory requirements), that is adequate in these circumstances; we need not second guess the particular strategy Teva has employed in its patent challenge.

Given this reasoning, FDA concludes that Teva, not Lupin, is a “first applicant” eligible for 180-day exclusivity based on Teva’s Paragraph IV certification to the ‘021 Patent contained in ANDA No. 79-081 (which the Agency approved on May 25, 2011).  A similarly strict reading of the statute also appears to be reflected in another recent FDA decision in which the Agency interpreted the 30-month date under FDC Act § 505(j)(5)(D)(i)(IV) for purposes of 180-day exclusivity forfeiture.

By Ricardo Carvajal –

FDA issued a letter of enforcement discretion for the use of certain qualified health claims on the labeling of an infant formula marketed by Nestle Nutrition (Gerber).  The claims provided in FDA's letter are:

• Very little scientific evidence suggests that, for healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow's milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life and up to 3 years of age.
• Little scientific evidence suggests that, for healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow's milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life.
• For healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow's milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life and up to 3 years of age. FDA has concluded that the relationship between 100% Whey-Protein Partially Hydrolyzed infant formulas and the reduced risk of atopic dermatitis is uncertain, because there is very little scientific evidence for the relationship.
• For healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow's milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life. FDA has concluded that the relationship between 100% Whey-Protein Partially Hydrolyzed infant formulas and the reduced risk of atopic dermatitis is uncertain, because there is little scientific evidence for the relationship.

In addition, FDA expects any of the above claims to be followed by the paragraph below:

Partially hydrolyzed formulas should not be fed to infants who are allergic to milk or to infants with existing milk allergy symptoms. If you suspect your baby is already allergic to milk, or if your baby is on a special formula for the treatment of allergy, your baby's care and feeding choices should be under a doctor's supervision. [(Emphasis in original.)]

The claims appear to be “D” level claims – the weakest claims for which FDA has been willing to grant the exercise of enforcement discretion.  Conventional wisdom holds that such claims are of limited value to industry.  Nonetheless, Gerber promptly touted the third of the four claims listed above in a full page ad in the New York Times – perhaps evidence that a “D” level claim is better than no claim at all. 

By Jamie K. Wolszon –

Trade reports recently indicated that FDA intended to issue by the end of May a draft guidance outlining its policy for “Research Use Only” (“RUO”) and “Investigational Use Only” (“IUO”) products such as reagents and instruments.  Last week FDA posted on its website a draft guidance setting forth its vision on the appropriate sale and distribution of those products.  (A copy of that draft guidance is available here.)  FDA later removed the document from the website, but not before multiple companies had obtained and circulated the document widely.  It is unclear what will be in the draft RUO/IUO guidance if and when FDA issues the document.  The agency may make revisions to the document that was posted last week.   

However, if adopted in the form it was posted, the document is likely to generate some controversy regarding a number of aspects.  Two of the elements that are particularly likely to draw attention are: (1) FDA states that if a manufacturer is aware that a customer is using the RUO or IUO product for diagnostic purposes, that the manufacturer should “halt” selling the product to the customer; (2) FDA states that products “intended for use in non-clinical laboratory research with goals unrelated to development of a commercial product, such as discovering and developing novel and fundamental medical knowledge related to human disease and conditions,” could qualify as RUO, along with RUO products intended to further refine or develop the assay.  This caveat that RUO eligibility depends on being intended to develop “novel and fundamental medical knowledge” is a tightening of FDA’s definition of RUO.

By Kurt R. Karst –      

Last Friday, Nostrum Pharmaceuticals, LLC (“Nostrum”) lodged a Complaint against FDA in the U.S. District Court for the District of New Jersey seeking declaratory and injunctive relief arising from the Agency’s decisions on pre-Medicare Modernization Act (“MMA”) 180-day exclusivity with respect to Nostrum’s ANDA No. 76-697 for a generic version of CARBATROL (carbamazepine) Extended-release Capsules, 300 mg, which FDA approved on May 20, 2011.  On that same day, FDA approved two other strengths under Nostrum’s ANDA – 100 mg and 200 mg – after the Agency determined that another applicant, CorePharma, forfeited post-MMA 180-day exclusivity eligibility.  Those strengths are not at issue in the lawsuit.  At issue is FDA’s application of the so-called “holding-on-the merits” standard with respect to one Orange Book-listed patent on which Nostrum qualified for 180-day exclusivity (U.S. Patent No. 5,912,013 (“the '013 Patent”)), and FDA's interpretation that 180-day exclusivity terminates with the July 5, 2011 expiration of another patent on which Nostrum qualified for 180-day exclusivity (U.S. Patent No. 5,326,570 (“the ‘570 patent”)).  Lerner, David, Littenberg, Krumholz & Mentlik, LLP and Hyman, Phelps & McNamara, P.C. represent Nostrum in the lawsuit.

CARBATROL is listed in the Orange Book with two patents – the '013 Patent, which expires on June 15, 2016, and the ‘570 Patent, which expires on July 5, 2011.  Nostrum was the first company to submit an ANDA containing a Paragraph IV certification to each patent, thereby qualifying the company for 180-day exclusivity based on each patent.   Under the pre-MMA statute, 180-day exclusivity is patent-by-patent and is triggered by the earlier of: (1) the first commercial marketing of the drug by a first filer; or (2) “the date of a decision of a court in [a patent infringement action] holding the patent which is the subject of the certification to be invalid or not infringed.” 

With respect to the court decision trigger to pre-MMA 180-day exclusivity, FDA stated in an April 11, 2006 letter to ANDA applicants that the Agency:

interprets the language of the court decision trigger provision . . . to require a court decision with an actual “holding” on the merits that the patent is invalid, not infringed, or unenforceable.  The holding must be evidenced by language on the face of the court’s decision showing that the determination of invalidity, noninfringement, or unenforceability has been made by the court. 

FDA’s May 20, 2011 Letter Decision concerning 180-day exclusivity for Carbamazepine Extended-release Capsules says that Nostrum’s exclusivity with respect to the ‘013 patent was triggered by a June 14, 2009 ruling in Shire Labs, Inc. v. CorePharma, LLC, C.A. 06-2266 (D.N.J.), in which the court entered a final judgment of its previous order granting CorePharma's motion for summary judgment of non-infringement of the '013 patent.  According to FDA, this “holding is adequate as a basis to trigger the running of exclusivity as to the '013 patent,” and thus “Nostrum's exclusivity with respect to the '013 patent has expired.”

Nostrum says in its May 27, 2011 Complaint that the June 2009 order “did not qualify as the type of order that can trigger the start of Plaintiff's 180 day marketing exclusivity period with respect to the '013 Patent,” and that “FDA's determination denying Plaintiff its entitlement to 180 day exclusivity based on the '013 Patent is an arbitrary, capricious and unlawful decision that this Court should set aside.”  Instead, says Nostrum, the court should rule that Nostrum “is entitled to 180 day marketing exclusivity based on Plaintiff's paragraph IV certification to the '013 Patent because the referenced 2009 court decision did not, and could not, trigger the running of Plaintiff's exclusivity period for the '013 Patent.”

With respect to exclusivity stemming from the ‘570 patent, FDA ruled that Nostrum is eligible for 180-day exclusivity, which was triggered on May 20, 2011 when Nostrum began commercial marketing.  The ‘570 patent, however, expires on July 5, 2011.  Nostrum says in its Complaint that:

Based on FDA's past decisions and on its publicly announced policy, FDA, upon expiration of the '570 Patent on July 5, 2011, will likely unlawfully approve pending ANDAs for Carbamazepine Extended release Capsules 300 mg in violation of 21 U.S.C. § 355(j).  FDA's approval of other ANDAs for extended release 300 mg Carbamazepine will deny Plaintiff, by more than four months, its right to exclusively market its 300 mg Carbamazepine drug product for the entire 180 day exclusivity period to which Plaintiff is entitled, causing Plaintiff to suffer irreparable harm.

Nostrum seeks declaratory judgments with respect to 180-day exclusivity for both the ‘013 and ‘570 patents, as well as a preliminary and permanent injunction prohibiting FDA from approving another ANDAs for Carbamazepine Extended release Capsules, 300 mg, “until the expiration of Plaintiff's full 180 days of marketing exclusivity based on either the '013 Patent or the '570 Patent.”

By Kurt R. Karst –

A group of nonprofit organizations has filed a Complaint seeking to compel FDA, by a court-ordered deadline, to withdraw approval for subtherapeutic uses of penicillin and tetracyclines in animal feed and to issue a final response to two Citizen Petitions submitted to the Agency – one on March 9, 1999 (FDA Docket No. 1999P-0485), and another on April 7, 2005 (FDA Docket No. 2005P-0139).  The Complaint, which alse requests declarations that FDA’s failure to withdraw approvals and delay in responding to the Citizen Petitions violate the Administrative Procedure Act (“APA”), was filed by the Natural Resources Defense Council (“NRDC”), the Center for Science in the Public Interest (“CSPI”), the Food Animal Concerns Trust (“FACT”), Public Citizen, and the Union of Concerned Scientists (“UCS”) in the U.S. District Court for the Southern District of New York on May 25, 2011.

The addition of low doses of antibiotics to livestock feed (e.g., chickens, turkeys, swine, cattle, and sheep) to ward off disease and promote growth has been going on for many decades, to the point that, according to the Complaint, “[t]oday, approximately 80 percent of all antibiotics used in the United States are used in livestock.”  FDA first approved the use of penicillin and chlortetracycline as animal feed additives in 1951, and the use of oxytetracycline as early as 1954. 

Not long after these approvals, however, concerns about the long-term use of antibiotics in animals, and antibiotic resistance in particular, were raised.  In the 1970s, FDA convened a task force to look into the issue.  The recommendations from the task force, including that “antibiotics used in human medicine be prohibited from use in animal feed unless they met safety criteria established by FDA,” led FDA to propose (in 1973) the withdrawal of approvals for subtherapeutic uses of antibiotics in animal feed unless data submitted to FDA resolved certain safety concerns.  After evaluating data and information submitted to FDA, the Agency issued Federal Register notices in 1977 with respect to penicillin and certain uses of tetracyclines proposing to withdraw all uses of penicillin and nearly all subtherapeutic uses of tetracyclines in animal feed.  Shortly thereafter, Congress stepped in and requested that FDA conduct further research before taking action on the withdrawal proposals.  This and other intervention by Congress led to the publication of several reports and studies in 1980, 1984, and 1988. 

Activity surrounding the issue of the long-term use of antibiotics in livestock continued in the 1990s with more reports.  In 2003, FDA issued a guidance document – Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern – discussing the Agency’s “recommended approach for assessing the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern.”  In 2004, “FDA sent letters to several manufacturers of approved animal feed products containing penicillin and tetracyclines, explaining that the administrative record did not contain sufficient information to alleviate FDA’s concerns about ‘the use of these products and their possible role in the emergence and dissemination of antimicrobial resistance,” according to the Complaint.  In 2010, FDA issued a draft guidance document – The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals – concluding that the “overall weight of evidence available to date supports the conclusion that using medically important antimicrobial drugs for production purposes is not in the interest of protecting and promoting the public health.”

Meanwhile, CSPI, FACT, Public Citizen, and UCS (several of the Plaintiffs named in the May 25, 2011 Complaint) petitioned FDA in 1999 and 2005 requesting that FDA “rescind approvals for subtherapeutic uses in livestock of any antibiotic used in (or related to those used in) human medicine” (1999), and “withdraw approvals for herdwidelflockwide uses of [specific] antibiotics in chicken, swine, and beef cattle for purposes of growth promotion (including weight gain and feed efficiency) and disease prevention and control (except for nonroutine use where a bacterial infection has been diagnosed within a herd or flock)” (2005).  FDA tentatively responded to the petitions – see, e.g., here – but has not yet issued final responses. 

The Plaintiffs allege in their Complaint that FDA, in violation of the APA, failed to comply with the Agency’s statutory duty to withdraw approvals of subtherapeutic uses of penicillin and tetracyclines in animal feed as required by FDC Act § 512(e)(1).  The Plaintiffs further contend that FDA’s failure to timely respond to the 1999 and 2005 Citizen Petitions with a final decision is an unreasonable delay in violation of the APA.  On both claims, the Plaintiffs request a judgment compelling FDA to take action by a court-odered deadline.

By Ricardo Carvajal –

Seaside Farm, Inc., a South Carolina tomato farmer, has sued the federal government under the Federal Tort Claims Act to recoup losses allegedly suffered as the result of the government’s misidentification of fresh tomatoes as the culprit in the outbreak of Salmonella Saintpaul that occurred in May 2008.  Seaside contends in its Complaint that FDA was negligent “in failing to identify any contaminated tomatoes from South Carolina before announcing a nationwide recall,. . .  failing to follow federal standards for laboratory verification and testing of scientifically knowable information,. . .[and] announcing a nationwide tomato recall and then contemporaneously acknowledging that the tomatoes from 41 states were safe,” among other actions.

In May 2008, CDC notified FDA that tomatoes were implicated in an outbreak of Salmonella Saintpaul. FDA initially warned consumers in New Mexico and Texas not to eat certain kinds of tomatoes, then expanded the warning nationwide.  Subsequently, certain kinds of peppers were identified as the likely culprit, and FDA lifted its warning on consumption of tomatoes – but not before the damage was done.  FDA has identified the Salmonella Saintpaul outbreak investigation as “an example of one of the most difficult traceback investigations.”

Although it’s cold comfort to Seaside Farms, new § 423(j) of the FDC Act (added by the FDA Food Safety Modernization Act or FSMA) requires FDA to establish an “incident command operation” for a Class I recall so as “to reduce the potential for miscommunication during recalls or regarding investigations of a food borne illness outbreak associated with a food that is subject to a recall.”  In addition, FSMA§ 206(e) directs the Government Accountability Office to submit a report to Congress that reviews “new or existing mechanisms available to compensate persons for general and specific recall-related costs when a recall is subsequently determined by the relevant agency to have been an error,” and that “considers models for farmer restitution implemented in other nations in cases of erroneous recalls.”

By Riëtte van Laack & Ricardo Carvajal –

As we reported on several occasions (see, e.g., here and here), recent Federal Trade Commission ("FTC") consent orders concerning health-related claims include the requirements that 1) certain claims be approved by FDA under the Nutrition Labeling and Education Act of 1990 ("NLEA") and 2) certain other claims be supported by two well-designed clinical studies to ensure that the claims are adequately substantiated.  Last year, POM Wonderful LLC ("POM") sued FTC claiming that these additional requirements exceeded FTC’s authority and constitute a violation of an advertiser’s First Amendment rights.  FTC promptly followed up with its own complaint against POM.  

Recently, the Alliance for Natural Health USA, Durk Pearson and Sandy Shaw (“Petitioners”) petitioned FTC essentially making the same arguments as POM and asking FTC for rulemaking to eliminate from its consent orders the requirements described above, which the petition characterizes as the “FDA Prior Restraint Requirement” and the “FTC Two Clinical Trial Requirement.”    Petitioners further ask FTC to implement the constitutional mandate that a federal agency refrain from imposing limits on future speech if the agency can identify a qualification for a claim that prevents deception.

Petitioners claim that they would like to market a prune juice product with a claim that it helps “relieve chronic constipation.”  Petitioners do not possess two well-designed clinical trials substantiating this claim and FDA has not approved the claim.  Petitioners assert that the requirements in the FTC consent orders constitute a rule within the meaning of the Administrative Procedure Act that prevents Petitioners from communicating truthful and not misleading information about the health benefits of their product.   

As explained by Petitioners, it has been firmly established by Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999) and its progeny (cases litigated by Petitioners) that the First Amendment protects the right of a party to make a truthful and not misleading claim that characterizes the relationship of a nutrient to a disease – even where that claim is supported by evidence that falls short of significant scientific agreement.  Petitioners argue that the holdings of these cases are equally applicable to FTC’s consent orders.  Petitioners assert that the federal government must allow nutrient-disease risk reduction claims backed by credible but inconclusive evidence to enter the market place, and rely on claim qualification as a less restrictive alternative to prohibition.  Further, the burden is on the government to prove (with empirical evidence) that no claim qualification will eliminate the allegedly misleading aspects of the claim. 

The petition raises questions concerning the constitutionality of FTC’s recent consent decrees and FTC’s approach to substantiation of health-related claims.  FTC’s guidance documents maintain that there is no fixed substantiation standard for such claims.  Yet the consent orders and FTC employees’ statements suggest that there is such a standard, namely at least two adequate and well-controlled human clinical studies – with no provision for the use of disclaimers.  The petition, however, is silent on the limits of constitutional protection when it comes to claims that a product treats (as opposed to reduces the risk of) disease.  Absent drug approval, FDA considers such claims unlawful and not entitled to constitutional protection – and the courts have agreed.  One thing is certain: where and how FTC draws the line between adequate and inadequate substantiation will continue to be a hot topic in 2011.

By Kurt R. Karst –      

The Federal Trade Commission’s (“FTC”) drumbeat of opposition to patent settlement agreements (or what opponents call “pay-for-delay” or “reverse payment” agreements) grew louder last week with the Commission’s submission of an amicus brief with the U.S. Court of Appeals for the Third Circuit in In Re K-Dur Antitrust Litigation, Case Nos. 10-2077, 10-2078, 10-2079.  The FTC requests  that the Court reverse a 2010 ruling from the U.S. District Court for the District of New Jersey in which the court adopted a Special Master’s Report and Recommendation in the long-running patent settlement dispute concerning K-DUR (potassium chloride).  In that case, direct purchasers of K-DUR alleged that Merck & Co., Inc. (“Merck”) (formerly Schering-Plough Corporation) restricted competition in violation of the Sherman Act by settling patent infringement lawsuits against potential generic K-DUR entrants.  Merck filed a motion for summary judgment and the Special Master appointed to preside over the case recommended that the motion be granted. 

The In Re K-Dur Antitrust Litigation followed an FTC action against Schering challenging the same settlements.  In 2005, the U.S. Court of Appeals for the Eleventh Circuit upheld in Schering-Plough Corp. v. FTC, 402 F.3d 1056 (11th Cir. 2005), a district court dismissal of that case.  In addition to the FTC, amicus briefs were submitted to the Third Circuit by the Department of Justice, Attorneys General from various states, the National Association of Chain Drug Stores, Inc., and the American Antitrust Institute – all decidedly in favor of a reversal of the New Jersey District Court’s decision. 

The FTC says in its amicus brief that the New Jersey District Court’s decision “is problematic in that it conflicts not only with basic antitrust principles, but with patent law and the policies of the Hatch-Waxman Act.”  First, according to the FTC, “[a]greements made by patent holders are subject to antitrust scrutiny, particularly where, as here, they eliminate potential competition by splitting monopoly rents with would-be competitors.”  Second, the FTC says that “[t]he district court’s rule – which allows such agreements as long as the patent infringement claim rises above the level of a ‘sham’ – is especially inappropriate in light of the policies of Hatch-Waxman, in which Congress expressly sought to encourage challenges to weak or narrow patents, and thereby spur early generic entry.”  The District Court’s rule would, according to the FTC, “negate such challenges by allowing a branded company simply to pay generic filers to stay out of the market until the patent expires.  Economic realities make such deals irresistible as long as they are condoned by the courts.”

Instead, the FTC says in its brief that the Third Circuit should adopt a “rule of reason”:

Patent settlement agreements should be assessed under the antitrust rule of reason – a rule that, as recent Supreme Court teachings make clear, is flexible enough both to take into account the patent context and to recognize a presumption of illegality for types of agreements whose likely anticompetitive impact is clear.  Parties may settle patent disputes in a variety of ways, and many settlements – e.g., those in which the parties compromise on an entry date, without payment by the patent holder – pose little competitive problem.  On the other hand, where a settlement includes a substantial payment, that payment must be a quid pro quo for something; if the challenger is offering a commitment to stay out of the market for a specified time, it follows that the payment is to secure exclusion of a potential competitor.  Because such an agreement closely parallels market allocation arrangements universally recognized as unlawful, a presumption of antitrust illegality is justified.  Such a presumption is bolstered by the policies of Hatch-Waxman and by experience that shows the vulnerability of many pharmaceutical patents, the weakest of which will be the most likely to result in exclusion-payment settlements.

The FTC’s amicus brief follows the U.S. Supreme Court’s March 7, 2011 denial of a  Petition for Writ of Certiorari in Louisiana Wholesale Drug Co., Inc., et al. v. Bayer AG, et al., Case No. 10-762, which involved manufacturers of Ciprofloxacin HCl (CIPRO) and whether a particular patent settlement agreement was per se lawful under the Sherman Act.  The Supreme Court was asked to review the case after the U.S. Court of Appeals for the Second Circuit denied without comment in September 2010 a Petition for Rehearing and Rehearing En Banc that a panel of the judges on the Court invited in their April 2010 decision affirming (3-0) a 2005 decision by the U.S. District Court for the Eastern District of New York granting summary judgment for defendants (i.e., Ciprofloxacin HCl manufacturers). 

FTC Commissioner J. Thomas Rosch discussed pending patent settlement challenges during a May 11th speech at the Sixth Annual In-House Counsel Forum on Pharmaceutical Antitrust, and again during a May 18th speech titled “The Intersection of Antitrust and Intellectual Property: The Quest for Certainty in an Uncertain World.”  During the May 11th speech, Commissioner Rosch expressed his pleasure that the Supreme Court denied Certiorari in the Cipro Case, saying “[t]hat is because Justices Sotomayor and Kagan recused themselves from the case.  Challengers to pay-for-delay agreements would likely have a far better chance at the highest court if all nine Justices were available to hear the case.” 

Commissioner Rosch also addressed rumors about a so-called FTC “Plan C” for addressing patent settlement agreements if the Commission is unsuccessful in the courts and in Congress, where retiring Senator Herb Kohl (D-WI) has pending legislation that would effectively ban patent settlement agreements.  Commissioner Rosch commented:

So does the Commission have a “Plan C” if we continue to be unsuccessful before both the judiciary and Congress?  At this point, the answer is no.  But, as I’ve said, one possibility would be for the Commission to exercise its rulemaking authority under Section 6(g) of the FTC Act.  Under this provision, the Commission can “make rules and regulations for the purpose of carrying out” the FTC Act.  It strikes me that the agency could issue a rule that would deem pay-for-delay agreements as inherently suspect.  The Commission would have the initial burden of production demonstrating the existence of a reverse payment settlement.  At that point, the burden of production would shift to the parties to justify the practice.  If they do so, the burden would shift back to the Commission, which would have to show under the full rule of reason that the agreement is anticompetitive.  Because the burden of proof ultimately rests with the Commission, I think this approach would pass muster under the Administrative Procedures Act, which governs Section 6(g) rulemakings.

By Susan J. Matthees –

FDA is extending the deadline for comments to the proposed rule on menu labeling from June 6 to July 5, 2011 (see our previous post here).  FDA states in a notice to be published in the Federal Register on May 24th that the Agency received several requests to extend the deadline.  The requests were for a variety of reasons, including a need to assess the effect of the proposal on industry, a desire for consumer research, and the complexity of the proposed rule.  FDA believes the 30-day extension will provide enough time for interested parties to respond. 

By Alan M. Kirschenbaum –

Today the Office of Pharmacy Affairs (“OPA”) of the Health Resources Services Administration (“HRSA”) published in the Federal Register its first proposed regulation under the 340B Drug Discount Program since the Program was established in 1992.  This Program, authorized under section 340B of the Public Health Service Act, requires manufacturers who execute a Pharmaceutical Pricing Agreement with the government to sell covered outpatient drugs to specified categories of covered entities at a price that does not exceed a statutory ceiling price.  Execution of the agreement is a condition for the federal government to pay for the manufacturer’s covered outpatient drugs under Medicaid and Medicare Part B.  The specified covered entities are several categories of clinics that receive federal grants as well as certain hospitals that serve low income populations.  HRSA has published guidance to implement the 340B Program, but has never before issued a regulation.

The Patient Protection and Affordable Care Act of 2010 ("ACA") made a number of changes to the 340B Program, including the addition of several types of hospitals to the list of eligible covered entities.  Beyond disproportionate share hospitals and children’s hospitals, which were eligible covered entities before the ACA was enacted, the ACA expanded the program to include free-standing cancer hospitals, critical access hospitals, rural referral centers, and sole community hospitals.  However, the ACA also contained an exception under which these new types of covered entity hospitals are precluded from obtaining 340B discounts for “a drug designated by the Secretary . . . for a rare disease or condition” – i.e., for a drug designated by the FDA as an orphan drug.  OPA’s proposed rule implements this restriction.

Interpretation of the statutory orphan drug exclusion is not as straightforward as it might seem, because many drugs are designated as orphan for certain indications but are also approved and/or prescribed for other, non-orphan indications.  Should a drug that has an orphan designation for one but not all of its indications be ineligible for 340B discounting, even if a hospital purchases it to use for a non-orphan use?  HRSA has decided no, and proposed an approach under which exclusion depends on the indication for which such a drug is used.  The proposed rule provides that, for the new categories of hospitals, a covered outpatient drug subject to 340B discounts does not include an orphan drug that is “transferred, prescribed, sold, or otherwise used for the rare condition or disease for which the drug was designated” as an orphan, but an orphan drug that is transferred, prescribed, sold, or otherwise used for a non-orphan indication is subject is 340B pricing.  This use-based approach is apparently HRSA’s attempt to balance the intent of the 340B program to provide low-cost drugs to hospitals serving low-income patients against the Congressional intent not to undermine pricing for drugs used to treat rare diseases.  However, there are several problems with HRSA’s interpretation.

First, it is inconsistent with the statutory language, which excludes a “drug” – not an “indication” – that has obtained an orphan designation from the FDA.  In addition, implementation of this rule would rely on the honor system.  Under the proposal, the responsibility rests with the hospital to ensure that orphan drugs purchased at the 340B price will not be prescribed or used for a non-orphan condition.  See proposed 42 C.F.R. § 10.21(c).  This is to be done by maintaining separate purchasing accounts, improving inventory and auditing capacity, and maintaining auditable records, which must be provided at the request of the government or a manufacturer.  The preamble makes clear that a manufacturer may not condition sales upon receiving prior assurance that the 340B drug will not be used to treat a rare disease or condition.

Reliance on an honor system to implement the orphan drug exclusion might be acceptable if OPA had the resources to conduct compliance audits of covered entities.  However, the OPA is notoriously underfunded and understaffed (an OPA official reported at a conference in March that OPA then had a staff of 15), and is unlikely to implement any routine auditing program in the foreseeable future.  Moreover, the statute does not authorize manufacturers to audit covered entities for compliance with the orphan drug exclusion (though it does authorize manufacturer audits of compliance with other 340B Program requirements).  The proposed regulation does refer to “government-approved manufacturer audits.”  However, such audits are expensive, particularly for orphan drug manufacturers, which tend to be smaller companies.  Even putting aside the cost of an audit, they are unlikely to be undertaken absent evidence of gross over-purchasing, so smaler-scale violations will go undetected. 

There is an alternative that does not rely on an honor system that is unlikely to be enforced.  That is to do as the statute mandates, and exclude “a drug designated [by the FDA] for a rare disease or condition,” even if the drug may have non-orphan indications.  Comments on the proposal must be submitted by July 19, 2011.

By Ricardo Carvajal –

In a report titled “Seafood Safety: FDA Needs to Improve Oversight of Imported Seafood and Better Leverage Limited Resources,” GAO found fault with many aspects of FDA’s imported seafood safety program.  GAO set the stage for its review by noting that more than 80% of seafood consumed in the U.S. is imported, and half of that is the product of aquaculture.  GAO than turned its attention to the use of antibiotics and antifungal agents in aquaculture, and the potential presence of residues in imported fish. 

GAO found FDA’s efforts wanting in comparison with the efforts made by regulatory authorities in other jurisdictions, such as the EU.  In part, GAO found that FDA’s foreign inspections are generally limited to a review of HACCP records, whereas those of the EU include visits to farms and testing laboratories; the EU requires foreign countries to demonstrate the equivalence of their seafood safety system or meet requirements established by agreement, whereas FDA does not;  FDA tests for residues of 16 unapproved drugs, whereas some EU countries test for residues of as many as 50 drugs; and FDA collects a small number of samples for testing (0.1% of imports) in comparison with the number collected by some other EU countries (as much as 4%).  GAO also found that FDA and the National Oceanic and Atmospheric Administration’s National Marine Fisheries Service (NMFS) “have made limited progress in implementing” an MOU executed by the two agencies in 2009, pursuant to which FDA is expected to increase its use NMFS’ inspection resources.

In its comments on the report, FDA (through DHHS) countered that “reading the GAO report may not result  in a full understanding of FDA’s multifaceted and risk-informed seafood safety program.”  Among other things, FDA noted that its testing is considerably more rigorous than that used in other jurisdictions, which in some instances has been shown to yield results of questionable validity.  FDA also noted that it plans to deploy new authorities under the Food Safety Modernization Act to help ensure the safety of imported seafood.  Notably, neither FDA nor GAO address what appears to be a key issue, namely why FDA has approved 5 drugs for use in aquaculture as compared to more than 15 in Japan and more than 30 in the EU.

The GAO report is doubtless welcome news for domestic catfish farmers, who succeeded in their bid to grant jurisdiction over catfish to the USDA via the 2008 Farm Bill, in part due to the purported inadequacies of FDA’s oversight.  The issuance of GAO’s report was touted in a press release by Sen. Thad Cochran (sponsor of the 2008 Farm Bill measure), who took the opportunity to encourage USDA to move forward with its implementing regulation.  Public meetings on that rulemaking are scheduled for May 24 and 26.

Those who prefer a more integrated approach to government regulation of food safety might recall that GAO recently issued a hefty report identifying “opportunities to reduce potential duplication in government programs, save tax dollars, and enhance revenue.”  GAO pointed to the nation’s fragmented food safety system as one such opportunity, and observed the following: 

Although reducing fragmentation in federal food safety oversight is not expected to result in significant cost savings, new costs may be avoided by preventing further fragmentation, as illustrated by the approximately $30 million for fiscal years 2011 and 2012 that USDA officials had said they would have to spend developing and implementing the agency’s new congressionally mandated catfish inspection program.