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 …
By John A. Gilbert, Jr. – After more than four months without any substantive registrant decisions, the Drug Enforcement Administration (“DEA”) published 11 administrative decisions within two days last week. Among these are two related cases involving allegations that a pharmacist failed to verify a prescriber DEA …
By Riëtte van Laack – Where’s the beef? It’s in a recent announcement from the USDA Food Safety and Inspection Service (“FSIS”) concerning finalized labeling requirements for mechanically, blade- or needle-tenderized beef. Under the new rule, published on May 18, 2015, raw or partially cooked mechanically tenderized …
By Karla L. Palmer – In addition to FDA’s request for nominations for bulk substances that may be used by outsourcing facilities for compounding animal medications (here) and draft guidance on compounding animal drugs from bulk substances (here), FDA also announced earlier this week that it is seeking comments on specific …
By Kurt R. Karst – On May 19th, the House Committee on Energy and Commerce took up consideration of the 21st Century Cures Act. The bill, H.R. 6, is a 309-page behemoth that was officially introduced on May 19th, and is the fourth iteration of the …
By Karla L. Palmer – Notwithstanding recognizing that sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) apply to compounding of human drug products, earlier this week the Food and Drug Administration (FDA) issued draft guidance on animal drug compounding, including compounding by section 503B outsourcing facilities. FDA …
