Earlier this week, FDA released its Justification of Estimates for Appropriations Committees for the Agency’s Fiscal Year 2027 (“FY2027”) budget request. Prior budget requests included a separate document titled “FDA Legislative Proposals” (see, e.g., here, here, here, and here; and our prior post here). The …
Two little mice fell in a bucket of cream. The first mouse quickly gave up and drowned. The second mouse, wouldn’t quit. He struggled so hard that eventually he churned that cream into butter and crawled out. Gentlemen, as of this moment, I am that …
While 3-year new clinical investigation exclusivity has never been the holy grail of exclusivities—we reserve that for 7-year orphan drug exclusivity or 5-year new chemical entity exclusivity (with the plus-5-year GAIN and plus-6-month pediatric exclusivity additions!) because of the different lengths and scopes—it plays an …
FDA’s September 22, 2025 News Release and announcement in a prepublication Federal Register notice (to be published on September 24, 2025) that GlaxoSmithKline’s (“GSK’s”) Wellcovorin (leucovorin calcium) Tablets, EQ 5 mg base and EQ 25 mg base, which was approved under NDA 018342 (initially approved …
Earlier this month, the Association for Accessible Medicines and its Biosimilars Council (“AAM”) announced (here and here) the release of a report, titled “Assessment of the Impact of Settlements,” examining the effects of patent litigation settlements on patient savings and access to generic drugs and …
The FDA Reduction-in-Force (Termination)—or “RIF(T)”—announced last week has resulted in countless stories in the press and on personal LinkedIn accounts from those RIF’d. As the dust begins to settle and we all assess what this means for the future of FDA and the public health, …
Last week, U.S. Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) announced the introduction of two bills we’ve seen before: (1) S. 1096, the Preserve Access to Affordable Generics and Biosimilars Act; and (2) S. 1095, the Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation …
We learned earlier this week that an allision (a runner-up to Merriam-Webster’s 2024 Word of the Year, polarization) may be poised to occur—perhaps within a fortnight (another runner-up to Merriam-Webster’s 2024 Word of the Year thanks to Taylor Swift)—as Congress considers various pieces of healthcare …
On August 30, 2024, we posted on what was then the most recent version of S. 142, the Preserve Access to Affordable Generics and Biosimilars Act. Some version of the bill, which addresses patent settlement agreements (pejoratively referred to as “reverse payment agreements” by their …
If you monitor Regulations.gov dockets and litigation dockets on PACER like we do, then you know that one company name—more than any other over the past several years—pops up: Vanda Pharmaceuticals, Inc. But unlike the fictitious Vandelay Industries of Seinfeld that George Costanza claims to …
In the Hatch-Waxman Community there are certain folks who are viewed as “the Founders” or pioneers of the law. There are, of course, the names Representative Henry Waxman and Senator Orrin Hatch, but there were several other Founders. One of them—who was said to have …
Forty years ago today—on a sunny Monday, September 24, 1984 at approximately 3:30 PM Eastern Time in the Rose Garden at the White House—President Ronald Reagan signed into law Public Law 98-417, the Drug Price Competition and Patent Term Restoration Act of 1984, stating that …
“Inter Partes Review” and “Section 101” are not terms you typically run into on this all-things-FDA blog, but we have talked about such patent-related issues before (here and here), and they are important legal (patent) principles, particularly in the context of drug and biological products …
Tell me doctor, where are we going this time? Is this the 90s, or 2025? Apologies to both Robert Zemeckis, who directed the 1985 classic “Back to the Future,” and to Huey Lewis and the News, which played “Back in Time” for the feature film, …
As readers of this blog know (see, e.g., here), the Affordable Generics (and Biosimilars) Act has been floating around in Congress for the better part of two decades. That bill, addressing drug (and later biological product) patent settlement agreements (pejoratively referred to as “reverse payment …
