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 …
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 …
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 …
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 …
In a case full of twists and turns, there’s a new twist! In March 2017, we reported on the status of litigation between FDA and Ferring Pharmaceuticals Inc. (“Ferring”) over the availability of 5-year New Chemical Entity (“NCE”) exclusivity for Ferring’s colonoscopy preparation, PREPOPIK (sodium picosulfate, …
On July 18, 2017, FDA held a highly anticipated public meeting discussing the balance between pharmaceutical competition and innovation. Titled “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access,” the meeting drew a tremendous response from industry with dozens of non-FDA or FTC …
Back in mid-May 2017, when FDA issued the fourth cumulative supplement to the 37th edition of the Orange Book, observant readers may have noticed a couple of interesting entries on page A-7 of the publication. There, in the “PATENT AND EXCLUSIVITY DRUG PRODUCT LIST,” FDA …
We’re tickled pink here at the FDA Law Blog when we see an issue raised in one of our posts addressed in legislation. That happened last week when Senators Orrin Hatch (R-UT) and Robert Menendez (D-NJ) introduced the latest iteration of the Orphan Products Extension …
The second iteration of the Generic Drug User Fee Amendments (“GDUFA II), which is contained in Title III of the FDA Reauthorization Act of 2017 (“FDARA”) (S. 934 and H.R. 2430) currently pending in Congress, will, if enacted, significantly change the current user fee system and …
In a new report issued earlier this week, titled “Generic Drug User Fees: Application Review Times Declined, but FDA Should Develop a Plan for Administering Its Unobligated User Fees,” the U.S. Government Accountability Office (“GAO”) examines several aspects of FDA’s implementation of the first iteration …
Although both the U.S. House of Representatives and U.S. Senate are still in the midst of considering legislation – the FDA Reauthorization Act of 2017 (“FDARA”) (H.R. 2430 and S. 934) – to, among other things, reauthorize an alphabet soup of user fee programs, including …
As we previously noted, the intersection of exclusivity and off-label promotion issues is not common, but quite an interesting issue nevertheless. The intersection of these issues was raised earlier this year when Egalet Corporation (“Egalet”) issued a press release saying that the company had received …
On June 8, 2017, after a long mark-up session, the House Energy and Commerce Committee unanimously (54-0) passed H.R. 2430, the FDA Reauthorization Act of 2017 (“FDARA”). The Senate version of the bill, S. 934, passed out of the Health, Education, Labor, and Pensions Committee …
The Orange Book has undergone – and continues to undergo – a lot of change as a result of FDA’s October 2016 promulgation of final regulations (effective as of December 5, 2016) to implement parts of the December 8, 2003 Medicare Modernization Act (“MMA”). We …
