By Kurt R. Karst – Just one day after FDA Commissioner, Dr. Margaret Hamburg, testified last week before the U.S. Senate Committee on Appropriations, Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies on FDA’s Fiscal Year 2011 budget request, which includes new user fees, …
By Ricardo Carvajal – During a webinar on immunity claims sponsored by the Food and Drug Law Institute, Richard Cleland, Assistant Director of FTC's Division of Advertising Practices, confirmed that enforcement actions are in the works against probiotic products that make inadequately substantiated claims. FTC …
By Susan J. Matthees – A new preemption decision has just come down from a California appeals court (the sixth circuit appellate district). In two consolidated cases, McGuan v. Endovascular Technologies, Inc., et al. and Johnson v. Endovascular Technologies, Inc., the appeals court upheld a lower …
By Kurt R. Karst – FDA’s recent announcement that the Agency approved IMPAX Laboratories, Inc.’s (“IMPAX”) ANDA No. 90-377 for the first generic version of Boehringer Ingelheim Pharmaceuticals, Inc.’s (“BI”) popular ($2.1 billion/year) treatment for benign prostatic hyperplasia, FLOMAX (tamsulosin hydrochloride) Capsules, has an interesting …
By Nisha P. Shah and Ricardo Carvajal – The title of a report issued by the U.S. Government Accountability Office (“GAO”) neatly sums up that agency’s perspective: “FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS).” The report …
By Kurt R. Karst – FDA’s recent approval of Nycomed U.S., Inc.’s ANDA No. 78-548 for a generic version of ALDARA (imiquimod) Cream, 5%, appears to be the first instance in which FDA has determined that a first ANDA applicant is eligible for 180-day exclusivity …
By Kurt R. Karst – The U.S. District Court for the Eastern District of Michigan (Southern Division) recently dismissed without prejudice a Complaint filed by Wyeth and granted a Motion to Dismiss filed by Sun Pharmaceutical Industries, Ltd. and Caraco Pharmaceutical Laboratories, Ltd. (“Sun”) in a Lanham Act …
By Kurt R. Karst – We’re food and drug attorneys, not patent attorneys. So, when the Federal Circuit issued its decision in Forest Group, Inc. v. Bon Tool Co. in late December 2009 concerning the false marking of spring-loaded parallelogram stilts, we didn’t pay any …
By Ricardo Carvajal – The ongoing recall of a widely used flavor enhancer known as hydrolyzed vegetable protein ("HVP") for possible contamination with Salmonella could mushroom to affect thousands of products. Although no illnesses have been reported thus far and FDA judges the risk to …
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 …
