A “clean” user fee bill with no congressionally added policy riders. It’s been a biopharma and med-tech dream for years. But now that U.S. Sen. Richard Burr (R-N.C.) has introduced such a bill, it could prove a nightmare, given competing legislation and the tight timetable for reauthorizing the user fee programs before the clock winds down on the current agreements Sept. 30 when fiscal 2022 ends.
It’s a delicate time in Europe, where the recovery from the pandemic has been stifled by the war on its doorstep in Ukraine. Although the crisis caused by the Russian invasion is dominating the short-term political agenda, there are serious concerns about Europe’s long-term economic prospects and whether its research-led industries are falling by the wayside.
The revised Build Back Better bill Democrats in the U.S. Senate are looking to pass in the next few weeks could deliver savings of $18 billion to $24 billion per year from 2028 through 2031 through drug pricing reforms that include direct Medicare price negotiations, according to a Congressional Budget Office estimate.
A few weeks ago, the odds of the deeply divided U.S. Congress passing drug pricing reforms that would allow direct Medicare negotiation seemed pretty slim. But those odds improved significantly July 6 when Senate Democrats reached a compromise on their version of the pricing provisions included in the Build Back Better bill, H.R. 5376, passed by the House last November.
It’s been a decade since the America Invents Act (AIA) transformed the U.S. patent landscape from a first-to-invent to a first-inventor-to-file system and added new contours with the creation of the Patent Trial and Appeal Board (PTAB) to hear post-grant patent challenges outside of court. While the AIA’s inter partes review process and other post-grant procedures have helped weed out weak patents, they’ve also increased the uncertainty and unpredictability of many patents. Now, 10 years on, Congress is assessing how the PTAB has developed in real life and considering what course corrections may be needed.
News that the U.S. FTC is finally going to reexamine the role of pharmaceutical benefit managers (PBMs) and their impact on prescription drug prices and availability is playing to applause from several sectors that have been complaining for years about PBM practices.
The U.S. FDA’s accelerated approval path is front burner these days, what with Congress looking to modernize the path through provisions added to the must-pass user fee legislation, the controversy still boiling over the FDA’s accelerated approval last year of Biogen Inc.’s Alzheimer’s drug, Aduhelm (aducanumab), and a number of recent withdrawals of drugs granted accelerated approval years ago.
Pivotal in killing the Biden administration’s Build Back Better budget legislation, Sen. Joe Manchin (D-W.Va.) is now working to revive parts of it, including the provision that would require Medicare to directly negotiate prescription drug prices.
Ignoring congressional sentiment, U.S. Health and Human Services Secretary Xavier Becerra announced the formal establishment of the Advanced Research Project Agency for Health as an independent entity within the NIH.
Pharmacy benefit managers (PBMs) were in the spotlight at a May 5 U.S. Senate subcommittee hearing on fairness and transparency in the prescription drug market, but lawmakers indicated they need to turn up the klieg lights of the FTC to penetrate the black box of PBM operations.
