On August 18, 2017, President Trump signed into law the Food and Drug Administration Reauthorization Act of 2017 (“FDARA”). In addition to reauthorizing and amending several drug and medical device provisions that were scheduled to sunset, FDARA also makes several changes to the law concerning …
In a settlement noteworthy to any company with a drug subject to a Risk Evaluation and Mitigation Strategy (“REMS”), on September 5, 2017, the U.S. announced a multi-million dollar civil settlement with Novo Nordisk for an alleged violation of REMS requirements for its drug Victoza …
Earlier this week, the U.S. Court of Appeals for the District of Columbia Circuit isued a 31-page Opinion handing FDA a victory in a dispute kicked off by Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceuticals Co., Ltd. (collectively “Otsuka”) after FDA’s October 5, …
Whether in the context of asserting First Amendment protection for a pharmaceutical manufacturer’s off-label promotion of an otherwise approved drug (see our previous post here), or successfully challenging FDA’s denial of New Chemical Entity exclusivity VASCEPA (icosapent ethyl) Capsules, 1 gram, (NDA 202057) (see our …
On Monday, August 28th, FDA announced the outlines of a long overdue policy change on stem cells. Based on Dr. Gottlieb’s statements in the FDA press release, it appears to have two prongs. First, the agency announced a crackdown on stem cell clinics that claim …
Children of the 1970/80s can easily recall that famous “How many licks does it take to get to the center of a Tootsie Pop?” commercial. Well, there’s a Hatch-Waxman version of that question: “How many approvals does it take to get to the center of 3-year …
As we mentioned back in July, courts continue to address a wide variety of procedural questions arising from the Biologics Price Competition and Innovation Act (“BPCIA”). The most recent is a decision from the Federal Circuit in an interlocutory appeal pending since July 2016 in …
On August 3, 2017, FDA announced the availability of a draft guidance regarding child resistant packaging statements on drug products labels and labeling. To be clear, this draft guidance addresses the inclusion of a voluntary statement in the labeling for drug products, prescription as well …
In a Complaint filed in the U.S. District Court for the District of Columbia last week, United Therapeutics Corporation (“UTC”) alleges that FDA unlawfully denied granting the company a period of orphan drug exclusivity upon the Agency’s December 20, 2013 approval of NDA 203496 for …
This was FDA’s recent admonition to ChemRite CoPac, Inc. (ChemRite), in a Warning Letter issued on June 29, 2017. Apparently the manufacturer of several over-the-counter oral rinses and oral moisturizing drug products uses the same equipment to manufacture numerous non-pharmaceutical materials, including an industrial car …
On July 27, 2017, the Drug Information Association (DIA) journal, Therapeutic Innovation & Regulatory Science, published recommendations from the Clinical Trials Transformation Initiative (CTTI) Patient Groups & Clinical Trials (PGCT) Project team, of which HP&M Attorney James E. Valentine is a member, on the best …
The Department of Justice announced on July 24, 2017, that Celgene agreed, without admitting liability, to pay a total of $280 million to settle a qui tam case relating to two of its drug products, Thalomid® and Revlimid®. The qui tam complaint filed in the …
On July 25, 2017, FDA announced the availability of a guidance on “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects.” FDA issued this guidance for immediate implementation, without initially seeking prior comment, based on …
Earlier this week, we discussed in a post how FDA, under the Agency’s decades-old regulations defining the term “same drug,” evaluates orphan drug “sameness” in the context of fusion proteins. At the end of that post we suggested that gene therapy “sameness” might be the …
FDA’s Orphan Drug Program, which traces its birth back to the January 4, 1983 enactment of the Orphan Drug Act (“ODA”) (see our previous post here), is probably one of the most successful FDA programs to date. The success of the ODA is most apparent …
