While typically, FDA is responsible for setting forth its own agenda and enforcing compliance with its own regulations, the Trump Administration’s HHS, on its way out the door in late 2020, took the unusual steps of withdrawing an important FDA Compliance Policy Guide, “Marketed Unapproved …
So-called “Pay-for-Delay” settlements, also called Reverse Payment, settlements—in which an innovator sponsor pays a generic sponsor to settle ongoing patent infringement litigation in exchange for a delay in generic market entry—have been fodder for antitrust concerns for decades (see, for example, our coverage from 2013). …
We have blogged recently about several FDA setbacks in court (here, for example). Add one more to that tally. Genus Medical Technologies secured an important victory in the D.C. Circuit Court of Appeals on Friday. In Genus Medical Technologies v. FDA, the Court of Appeals ruled …
There’s no question that drug pricing is one of the most important issues in health care right now, and while such pricing considerations are outside FDA’s statutory mandate, it has not stopped FDA from trying to address pricing issues through enhancing drug competition (see, for …
Perhaps when you’re carving out a patented method of use? Well, at least that’s what GSK is arguing. As the now-infamous GSK v. Teva case makes its way through the Federal Circuit once again to address what many have called the death-knell to skinny-labeling (also …
Those of you keeping up with the Orange Book know that FDA has been considering changes to patent listing requirements, many of which industry has been requesting for decades. Now, Congress is trying to facilitate effective administration of the Orange Book. On January 5, 2021, …
Biosimilars have been around for a bit over 10 years now, and there has been tremendous progress in licensing new biosimilar products. But there is no question that there are still significant holes that FDA must address to further facilitate biosimilar development under section 351(k) …
The FDA Law Blog may appear to have become a little patent-heavy over the last few months, but you can thank the Federal Circuit for that. It just can’t stop changing the landscape for Hatch-Waxman litigation. In October, the Federal Circuit, for all intents and …
The Priority Review Voucher (“PRV”) program is a powerful incentive to encourage sponsors to develop treatments for conditions that are not ordinarily priorities for industry, such as infectious diseases for which there is no significant market in developed nations (tropical disease) or rare pediatric diseases. …
Identification of and comparison to a Reference Listed Drug (“RLD”) and Reference Standards (“RS”) are the lynchpin of generic drug development and approval. It’s therefore no surprise that, upon significantly updating the Orange Book in January 2017, FDA dedicated an entire guidance to fundamental definitions …
Back on August 20, 2020, the Drug Enforcement Administration (“DEA”) issued an Interim Final Rule (“IFR”) purporting to “clarify” certain provisions of the Agriculture Improvement Act of 2018 (“AIA”). As we explained back when Congress passed the AIA in December 2018, the AIA upended the …
2020 was supposed to be a year remembered for the 40th anniversary of the publication of the Orange Book—a celebration of one aspect of the Hatch-Waxman Amendments—but it could turn out that 2020 is remembered as the year in which the Hatch-Waxman Amendments took a …
Californovation (sung to the tune of the Red Hot Chili Peppers’ Californication, obviously): the new portmanteau seems appropriate for California, who just keeps coming up with new ideas to address the many hurdles consumers face with respect to access to affordable medicines. Last year, we …
Every so often, FDA revisits a policy set forth in FDA’s Manual of Policy and Procedures (“MAPP”) to reflect the Agency’s current practices. Though MAPPs really only govern the actions of the Agency, their content is important to understanding how FDA will approach certain requests. …
Earlier this week, FDA was supposed to issue proposed rules—years in the making—implementing over-the-counter (OTC) hearing aid rules, as required by the Food and Drug Administration Reauthorization Act (FDARA) (read HPM’s summary here). Under FDARA, FDA is required to issue proposed rules three years from …
