This third installment of our series analyzing the rider provisions in the fiscal year 2026 appropriations legislation continues our examination of key FDA policy directives embedded in congressional committee reports. This post focuses on provisions related to medical devices, pharmacy compounding, GLP-1 medications, and food-areas …
This is the second in our series analyzing the riders attached to the FY 2026 Labor-HHS Appropriations Bill. This installment examines the drug-related provisions, which cover a wide range of topics from accelerated approval and rare disease therapies to biosimilars and opioid regulation. The Committee’s …
On May 1, 2026, the House Committee on Appropriations submitted House Report 119-632 to accompany H.R. 8646—the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for Fiscal Year 2027, which passed on June 4, 2026. The report serves as the Committee’s …
Listing patent information in the Orange Book is one of the most important things you can do as an innovator sponsor to ensure that your property rights are respected. And, of course, it’s statutorily required. So that makes the new guidance FDA just issued on …
The skinny label is back from the dead. While back in 2021, it seemed like the skinny label was effectively dead after the Federal Circuit twice held Teva liable for induced infringement of GSK’s labeling in GSK v. Teva, the Supreme Court breathed new life …
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 …
Are compounders on notice? FDA may be coming for at least one of them, with a little help from its friends at the Justice Department. On the heels of the Novo Nordisk’s Wegovy® pill launch, Hims & Hers, in a headscratcher of a promotional move, doubled …
February is Rare Disease Month, an important time to celebrate successes in addressing the needs of our fellow 25 to 30 million Americans living with a rare disease, but also to renew our resolve in addressing the much larger remaining challenges – both new and …
As some of you know, tucked inside the Consolidated Appropriations Act of 2026, was some legislation that FDA has been pushing for quite some time. In addition to the incredibly important renewal of the Rare Pediatric Disease Priority Review Voucher program (blog on that forthcoming), …
The skinny label has hit the big time. Last week, the Supreme Court agreed to hear Hikma v. Amarin to address the burning question of whether a carve-out induces infringement. As of now, the Federal Circuit has been very clear that a carve-out can induce …
Priority Review Vouchers (PRV) are incredibly valuable—several have sold for hundreds of millions of dollars. Which is why it makes sense that Sun Pharma Advanced Research Co. Ltd. and Sun Pharmaceutical Industries, Inc. went to the mat fighting FDA for a PRV for phenobarbital. And …
Biosimilars, costing about 50% of their reference products, have generated $56 billion in healthcare savings since 2015, with $20 billion saved in 2024 alone. Compared to the small molecule market though, that’s pocket change. It should come as no surprise therefore that FDA is actively …
FDA has long permitted ANDA applicants to “carve-out” patent-protected uses from product labeling, resulting in differences between the Reference Listed Drug and the ANDA. Legal challenges to the carve-out are not new: The GSK v. Teva saga, followed by the Amarin v. Hikma litigation, made …
Note: This HPM Fact Sheet, like HHS’s recently issued Fact Sheet, is intended to bring some radical transparency to the discussion around the recently announced DTC Rx drug ad “crackdown.” These bloggers thought it would be helpful to clarify some issues. On September 9, 2025, President …
It was about a year and a half ago that we first proclaimed mass hysteria when FTC crossed streams into FDA territory, but perhaps our cries were premature. As we mentioned last year, a large number of the drug companies targeted by FTC in its …
