On Friday, the Yale Law School Media Freedom and Information Access law clinic filed a complaint against FDA, HHS, and NIH alleging violations of the Administrative Procedure Act based on Section 801 of the FDA Amendment Act (FDAAA), which requires results reporting of clinical trials …
While riding out the end of this term, the Government Accountability Office (GAO) delivered to our lame duck Congress some light reading on orphan drug designations and marketing. In a report titled “FDA Could Improve Designation Review Consistency; Rare Disease Drug Development Challenges Continue,” the …
Back in October, FDA announced that it submitted a proposal to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) for the development of common global standards for generic drugs. This proposal is yet another strategy in Commissioner Gottlieb’s Drug …
Only ten years after initiating the withdrawal process, FDA approval for prescription PEG-3350 is officially withdrawn. The D.C. Circuit issued an unpublished opinion this week affirming FDA’s April 2018 Order withdrawing approval for several PEG-3350 ANDAs and denying requests for a hearing by the affected …
Last week, the President signed into law a bill that gives the FTC greater authority to police agreements between biologic license holders and biosimilar applicants – so-called “pay-for-delay” settlements. The FTC has been focused on these settlements in the pharmaceutical space for years, but until now …
For years, FDA has been looking to reform the Citizen Petition process to address allegations of “gaming” the system to delay competitor approval. This led to the creation of the “505(q)” petition by Congress in 2007 as part of FDAAA, the subsequent revision of the …
After submitting five Citizen Petitions to FDA since 2016 (see Docket Nos. FDA-2018-P-2851; FDA-2017-P-4352; FDA-2017-P-3064; FDA-2017-P-1359; FDA-2016-P-0645) alleging that evidence does not support approval of opioids, Pharmaceutical Manufacturing Research Services (“PMRS”) is trying a new tactic to challenge FDA’s regulatory scheme for abuse-deterrent opioids: court. PMRS …
An interesting Citizen Petition popped up earlier this week in which pharma giant Pfizer has requested FDA guidance on sponsor communications about biosimilar products. This is not a new campaign for Pfizer, who has emphasized the need to address anticompetitive exclusionary practices, “misinformation,” and market …
Well, we haven’t quite waited the lifetime that Foreigner did, but it’s exciting nonetheless. Only about one year after signing the provisions into law, FDA announced the approval of the first generic drug with a Competitive Generic Therapy (“CGT”) designation: ANDA 211067 for potassium chloride …
With one paragraph in a Summary Judgment Order issued last week, the Northern District of California further expanded the patent safe harbor under 37 U.S.C. § 271(e)(1). Though not a huge leap from previous safe harbor decisions, the Order in Nevro Corp. v. Boston Scientific Corp. …
Just like last year when it held a public hearing and rolled out the Generic Drug Action Plan, FDA is following its recent announcement of the Biosimilar Action Plan with a Public Hearing on competition in the biologics market entitled Facilitating Competition and Innovation in …
Though the pace of biosimilar approval has quickened substantially over the last year (with 6 approvals since this time last year alone), the biosimilar market remains sparse and slow. Unsurprisingly, FDA has noticed. This week, FDA unveiled a Biosimilars Action Plan (BAP) aimed at speeding …
Announced as another effort to improve patient access and address drug pricing, FDA recently finalized two guidance documents intended to facilitate better communication and negotiation with payors, formulary committees, and others: Medical Product Communications That Are Consistent With the FDA-Required Labeling – Questions and Answers: Guidance …
In an attempt to ensure that implementation of the FDCA requirement for shared REMS does not cause undue burden, FDA released two new guidance documents targeting shared REMS systems. We have seen the negotiation of shared REMS systems succeed – and fail spectacularly resulting in waivers. …
FDA announced last week its newest initiative to address alleged “gaming” tactics that FDA believes are used to circumvent the delicate balance of innovation and competition set forth by Congress in the Hatch-Waxman Act. As part of FDA’s Drug Competition Action Plan, FDA has published …
