By Alexander J. Varond & James E. Valentine* – FDA recently released a draft guidance, titled “Rare Diseases: Common Issues in Drug Development.” The fourteen-page document amounts to more of a primer than a focused discussion of technical issues. It serves as a useful reminder of the …
By James E. Valentine* – On August 17, 2015, FDA announced the availability of an update to its 11 year old guidance on botanical drug development. Botanicals are plant materials, algae, macroscopic fungi, and combinations of those things that can be regulated as a food (including a …
By Riëtte van Laack - As we previously reported, FDA and FTC are reviewing their regulation of homeopathic drugs. In March 2015, FDA issued a notice requesting comments on the current use of homeopathic drugs, and that agency’s approach to regulation of the category. In June 2015, FTC …
By James C. Shehan – We’ve all been told that consistency is a virtue and some recent developments have AbbVie’s consistency on display while that company questions FDA’s biosimilar labeling morality, or at least decision-making. In a citizen petition supplement recently submitted to FDA, AbbVie renewed …
By Jenifer R. Stach* & Ricardo Carvajal – On July 24, 2015, FDA issued a proposed rule amending the Agency’s previously issue proposed rule on Accreditation of Third-Party Auditors/Certification Bodies (see our prior posts here and here) and establishing user fees for the Agency’s proposed accreditation …
By Karla L. Palmer – The GAO was asked to review DEA registrants’ and others’ interactions with DEA. The GAO Report, released at the end of July examines the following: (1) To what extent registrants interact with DEA about their Controlled Substances Act (CSA) responsibilities and registrants’ …
By Kurt R. Karst – Back in September 2013, when FDA’s Office of Generic Drugs (“OGD”) was gearing up for significant implementation of the Generic Drug User Fee Amendments of 2012 (“GDUFA”) (and the associated Performance Goals and Procedures), the Office issued a Manual of Policies …
By Kurt R. Karst – It seems that hardly a week passes (and sometimes, hardly a day or two) without news of a new merger or acquisition in the pharmaceutical or biotechnology industries. Indeed, 2015 may be a record-breaking year for such deals (see here, here, …
By James C. Shehan – In the latest Biologics Price Competition and Innovation Act of 2009 ("BPCIA") patent dance development, Amgen filed a lawsuit alleging that Apotex’s biosimilar of Neulasta (pegfilgrastim) infringes two Amgen patents, one about to expire composition of matter patent and one process …
By Jamie K. Wolszon – As we have previously blogged on numerous occasions, FDA has released a framework for regulation of laboratory-developed tests (LDTs) that has sparked considerable controversy. The Association of Molecular Pathology (AMP), which represents molecular pathologists and has been an active participant in …
By David C. Gibbons & Alan M. Kirschenbaum – The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) has recently issued two Advisory Opinions involving patient benefits provided by drug and device manufacturers. Advisory Opinion 15-11, posted today, involves a manufacturer’s short-term …
By Kurt R. Karst – Earlier this week, the U.S. District Court for the District of Maryland unsealed a 73-page Opinion handed down on July 29, 2015, along with an Order, in a challenge brought by Mallinckrodt Inc. (“Mallinckrodt”) last November after FDA downgraded from “AB” …
By Jenifer R. Stach* – After Stewart Parnell’s conviction for selling salmonella-tainted peanut products, causing many deaths and illnesses, he could be facing life in prison. Attorneys on both sides called the recommendation for a life sentence “unprecedented” for a food-poisoning case. We wrote about the convictions …
By Kurt R. Karst – There are few things this blogger relishes more in his practice than getting his hands on FDA exclusivity decisions. (It’s like being given and then unwrapping a holiday gift.) We don’t mean the “decisions” that most people see in ANDA approval letters …
By David C. Gibbons – On Friday, August 7, Judge Paul Engelmayer, U.S. District Court for the Southern District of New York, handed down one of the most significant rulings concerning First Amendment protection for a pharmaceutical manufacturer’s off-label promotion of an otherwise approved drug. Judge …
