By Ricardo Carvajal – In an unusually public manner, FDA announced the issuance of an assignment to its field staff to collect official samples of raw food intended for consumption by dogs or cats. The samples will be analyzed for Salmonella, Listeria monocytogenes, E. coli O157:H7, and non-O157:H7 Shiga toxin-producing E. coli (known …
By Jeffrey K. Shapiro – In 1987, an FDA official testified that 20 hours were spent on average to review a 510(k) submission. Hearings before the Subcommittee on Health and the Environment of the House Committee on Energy & Commerce, 100th Cong., 1st Sess. (Ser. No. …
By James E. Valentine* & Jay W. Cormier – On June 1, 2015, FDA announced the availability of a draft guidance for industry entitled “Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products.” The draft guidance is intended to address a “lack of clarity” …
By Kurt R. Karst – We thought FDA would be hauled into court after the Agency denied, on October 10, 2014, two Petitions for Reconsideration (here and here) asking the Agency to rethink a February 21, 2014 Consolidated Response Denial to three Citizen Petitions requesting that …
By Karla L. Palmer – As announced in the Federal Register on June 3, 2015, FDA is proposing to deschedule [123I]Ioflupane (ioflupane) from Schedule II of the Controlled Substances Act (CSA). Ioflupane is an active pharmaceutical ingredient and new molecular entity in DaTscan, which is a …
By Wes Siegner – FDA held a public hearing titled “Homeopathic Product Regulation” on April 20 and 21 of this year. Now the FTC has announced that it will hold a “Workshop” to examine advertising for over-the-counter (OTC) homeopathic products on September 21. FDA’s Federal Register Notice …
By Kurt R. Karst – It was just a few weeks ago that we noted in a post concerning FDA’s recently finalized guidance document on “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product” that the Agency removed from the 2012 draft version of the document …
By Kurt R. Karst – Here we are . . . on the eve of Oral Argument before the U.S. Court of Appeals for the Federal Circuit in a dispute over the applicability and correct interpretation of various provisions of the the Biologics Price Competition and …
By David C. Gibbons – In a letter sent to Acting FDA Commissioner Ostroff on May 27, 2015, the House Committee on Energy and Commerce (“EC Committee”) informed FDA that it is examining FDA’s “policies and practices regarding the use and publication of untitled letters, including …
By Ricardo Carvajal - FTC updated a Q&A on its Endorsement Guides, which set forth administrative interpretations of relevant provisions of the FTC Act as they apply to the use of endorsements and testimonials in advertising (the Endorsement Guides were last updated in 2009 – see …
By Kurt R. Karst – [FDA’s] ultimate conclusion that Vascepa, a drug “no active ingredient of which . . . has been approved” in a previous NDA, was not entitled to exclusivity, is contrary to the statute’s plain meaning. Rather than explaining this discrepancy, the administrative …
By Kurt R. Karst – Like rapid gunfire (judicial style), two courts – the U.S. District Court for the District of Maryland and the U.S. District Court for the District of Columbia – issued decisions on May 27, 2015 within hours of one another denying challenges …
By Douglas B. Farquhar – When plaintiffs’ attorneys seek to recover damages because of alleged frauds committed on the federal government – obtaining massive attorneys’ fees and whistleblower bounties for doing so – they frequently argue that no claim is untimely, because of the wars in …
By Kurt R. Karst – We like simplicity. After all, it is, as Leonardo da Vinci reportedly once said, “the ultimate sophistication.” We also like simple FDA-related legislation; but that’s not something we see all too often. (We also don’t often see legislation addressing Prescription-to-Over-the-Counter (“Rc-to-OTC”) …
By Karla L. Palmer – Last week, Senator David Vitter (R-LA) introduced S. 1406, the Saving Access to Compounded Medications for Special Needs Patients Act, to amend Section 503A of the Federal Food, Drug, and Cosmetic Act. The amendment addresses confusion over a compounding pharmacy’s “distribution” of …
