Hyman Phelps McNamara

Yep, it’s been three years since we started FDA Law Blog.  And that means it’s time again to take a minute from blogging on FDA issues to pat ourselves on the back.  It’s been a banner year for us.  We recently topped 800 posts (almost …

By Kurt R. Karst –       Earlier today, FDA sent a letter to Senator Charles Grassley (R-IA) indicating that the Agency may very well be poised to increase prosecution of company officials.  According to the letter, which includes several recommendations based on a committee the Agency formed …

By Kurt R. Karst –     Citing FDA approval standards that “may deny the benefits of medical progress to seriously ill patients who face morbidity or death from their disease,” Representative Diane Watson (D-CA) introduced H.R. 4732, the Compassionate Access Act of 2010, earlier this week.  …

By Cassandra A. Soltis – Think twice before putting that claim on your food label – or on your website.  Just last month, FDA issued 16 Warning Letters to food manufacturers regarding unauthorized nutrient content and health claims appearing in food labeling.  In addition, some …

By Kurt R. Karst –       Earlier today, the U.S. Court of Appeals for the District of Columbia Circuit handed Teva Pharmaceuticals USA, Inc. (“Teva”) a significant victory in the company’s lawsuit against FDA concerning the availability of 180-day exclusivity for generic versions of Merck & …

By Kurt R. Karst –       The Patent and Trademark Office’s (“PTO’s”) recent denial of a Patent Term Extension (“PTE”) for U.S. Patent No. 5,270,305, which was reissued as U.S. Patent No. RE40,045 (“the ‘045 patent”), covering Glaxo’s ADVAIR DISKUS (fluticasone propionate; salmeterol xinafoate) should be the …

By David B. Clissold & Carrie S. Martin – Last Friday, FDA issued two new draft guidance documents regarding clinical trial designs: Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics (February 2010) and Guidance for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 These draft guidance …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 …