By Etan J. Yeshua – Drug developers targeting acute migraines may now have a new path to approval. In a draft guidance document issued on Tuesday by the Division of Neurology Products ("DNP"), FDA offers a novel primary endpoint that has not been used before to …
By Jay W. Cormier & Alan M. Kirschenbaum – As we previously reported, in late August, the U.S. District Court for the District of Columbia denied PhRMA’s request that the Court vacate a recent HRSA interpretive rule on the orphan drug exception under the 340B drug …
By Kurt R. Karst – For several months now we have been monitoring an appeal to the U.S. Court of Appeals for the Federal Circuit concerning a patent – U.S. Patent No. 6,878,703 (“the ‘703 patent”) – listed in the Orange Book for Daiichi Sankyo Inc.’s …
By Kurt R. Karst – In recent comments submitted to FDA, the American Academy of Pediatrics (“AAP”) is taking a stand against the relief requested in a June 2014 Citizen Petition (Docket No. FDA-2014-P-0830) submitted on behalf of Merz North America. The petition calls into question …
By Kurt R. Karst – Last Friday morning (October 10th) something interesting popped up out of the blue on FDA’s “What’s New Related to Drugs” webpage: the final version of FDA’s “Guidance for Industry – New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products.” But …
By Andrew J. Hull* & William T. Koustas – FDA has published its second draft guidance in a much-awaited series of industry guidance documents related to the implementation of the Drug Supply Chain Security Act ("DSCSA"), enacted on November 27, 2013. (We posted on the first …
By Kurt R. Karst – Colchicine is one of those drugs that has a long and storied history at FDA. It’s an old drug (about 200 years old) that was marketed for decades without FDA approval. Then, in 2009, FDA approved Mutual Pharmaceutical Company, Inc.’s (and …
By Jamie K. Wolszon – On September 25, 2014, the U.S. District Court for the Northern District of Illinois Eastern Division dismissed a claim that a drug company co-pay subsidy program (also known as coupon program) violated the Racketeer Influenced and Corrupt Organizations Act (RICO) under theories …
By Kurt R. Karst – In a September 30, 2014 decision, a unanimous panel of judges from the U.S. Court of Appeals for the Ninth Circuit affirmed an August 2013 decision from the U.S. District Court for the Northern District of California finding that a first-in-the-nation …
By Kurt R. Karst – As most folks know by now, earlier this month the President’s Council of Advisors on Science and Technology (“PCAST”) released a report to the President titled “Combating Antibiotic Resistant Bacteria.” The report is part of a broader initiative announced by The …
By Kurt R. Karst – Thanks to everyone who participated in our “30 for 30” Hatch-Waxman Trivia! Based on the corrrespondence we received since posting the trivia questions earlier this week, FDA Law Blog readers enjoyed the trip down memory lane. . . and were entertained along the …
By James C. Shehan – With the posting on Friday of a report, a special advisory bulletin and a podcast, the HHS OIG staked out some new ground in the healthcare fraud and abuse landscape. The report shows that significant numbers of Medicare beneficiaries use copay …
By Kurt R. Karst – It’s difficult to believe that almost 30 years have passed since President Ronald Reagan signed into law the Drug Price Competition and Patent Term Restoration Act of 1984 on September 24, 1984. So much in Hatch-Waxman law (or Waxman-Hatch law if …
By Kurt R. Karst – There have been rumors floating around Washington, DC for a few months that efforts were afoot to introduce legislation to amend the FDC Act to address the availability of products subject to a restricted distribution program to generic drug and biosimilar …
By Kurt R. Karst – There are mortal sins and there are venial sins. In the latest guidance documents FDA announced (here and here) earlier this week – a final guidance on ANDA Refuse-to-Receive (“RTR”) standards and a draft guidance on ANDA RTR for lack of …
