By David B. Clissold & Carrie S. Martin – Last Friday, FDA issued two new draft guidance documents regarding clinical trial designs: Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics (February 2010) and Guidance for Industry: Non-Inferiority Clinical Trials (March 2010). These draft guidance …
The Washington Legal Foundation has published a Legal Opinion Letter authored by Hyman, Phelps & McNamara, P.C., attorneys Jeffrey N. Wasserstein and Nisha P. Shah. The article, with the catchy title "Court Empowers Qui Tam Defendants To Sue Third Parties For Indemnification," expands on our …
By Kurt R. Karst – FDA’s Office of Generic Drugs (“OGD”) has a backlog of Abbreviated New Drug Applications (“ANDAs”) that is nearing 2,000, according to OGD Director Gary Buehler, who presented the data at the recent Generic Pharmaceutical Association (“GPhA”) Annual Meeting. OGD’s median …
By Kurt R. Karst – In yet another setback to the Federal Trade Commission’s (“FTC’s”) battle against settlement agreements between brand name and generic drug companies – so-called “reverse payments” or what the government now calls “pay-for-delay” agreements – the U.S. District Court for the …
By Alan Kirschenbaum — In an effort to salvage health care reform, the Obama Administration will hold a bipartisan health care reform meeting this Thursday, February 25. Invited are the Congressional leadership of both parties and the Chairmen and ranking membership of committees involved in health …
By David B. Clissold and Nisha P. Shah On February 19, 2010, FDA issued a proposed rule that would require sponsors to report any person that has or may have engaged in the falsification of data in studies that involve human or animal subjects. FDA believes …
By William T. Koustas — The FDA has announced that it will require all drugs known as Erythropoiesis-Stimulating Agents (“ESAs”) to have a Risk Evaluation and Mitigation Strategy (“REMS”). At the present time, this class of drugs is limited to three Amgen products: Procrit, Epogen (both …
By Ricardo Carvajal and A. Wes Siegner – According to a press release issued by FTC, the agency “has sent letters to 11 companies that promote various Omega-3 fatty acid supplements, telling them they should review their product packaging and labeling to make sure they do …
By Douglas B. Farquhar – A recent of a New Jersey federal court is bound to encourage some manufacturers of an FDA-approved version of a long-marketed drug to sue competitors that continue to market unapproved versions of the same drug. Mutual Pharmaceutical Company, Inc. and …
By Ricardo Carvajal – In an effort to grant FDA additional authority over dietary supplements, Senators John McCain and Byron Dorgan have introduced the Dietary Supplement Safety Act of 2010. The bill would require dietary supplement facilities to provide FDA with information on supplements and …
By Alan M. Kirschenbaum – Late last year, we reported on a decision of the D.C. District Court upholding the Department of Defense’s ("DOD’s") authority to apply Federal Ceiling Price ("FCP") limitations to all prescriptions filled on or after January 28, 2008 under the TRICARE …
By Kurt R. Karst – Two recent rulings out of the U.S. District Court for the Eastern District of Pennsylvania stemming from allegations about antitrust violations from the submission of citizen petitions have once again raised the issue of so-called “sham” citizen petitions and, insofar …
Hyman, Phelps & McNamara's Jeffrey N. Wasserstein (co-chief blogger at fdalawblog.net and self-described social media guru) will be speaking on the regulation of social media at the American Conference Institute’s 8th Expert Regulatory Guide to Advertising, eMarketing and Promotions for the Pharmaceutical Industry, taking place in …
By Kurt R. Karst – FDA’s ability to force a prescription-to-over-the-counter switch (“Rx-to-OTC switch”) has been hotly contested over the past decade. The crux of the debate concerning forced Rx-to-OTC switches is whether FDA, absent a New Drug Application (“NDA”) sponsor’s consent, has the authority …
By Michelle L. Butler – This week, the parties in the Winston Laboratories case filed a Stipulation of Dismissal with Prejudice Pursuant to Fed. R. Civ. P. 41(a). This case involved FDA’s interpretation of the term “affiliate” in its decision to deny Winston a small …
