When it comes to recommending reforms for the U.S.’ 30-year-old 340B Drug Discount Program, there’s one thing drug manufacturers and hospitals agree on – pharmacy benefit managers (PBM) and other middlemen should not be profiting from a program that’s intended to help uninsured and vulnerable patients gain access to affordable prescription drugs or other health care services.
While U.S. politics continues to delay Senate confirmation of the NIH director, other crucial positions at the agency that don’t require Senate action are being filled. Acting NIH Director Lawrence Tabak announced Aug. 2 that he has named Jeanne Marrazzo as director of the agency’s National Institute of Allergy and Infectious Diseases (NIAID).
While U.S. politics continues to delay Senate confirmation of the NIH director, other crucial positions at the agency that don’t require Senate action are being filled. Acting NIH Director Lawrence Tabak announced Aug. 2 that he has named Jeanne Marrazzo as director of the agency’s National Institute of Allergy and Infectious Diseases (NIAID).
The old adage of “what goes up must come down” rarely applies to U.S. FDA user fees. Most of the fiscal 2024 fees, which go into effect Oct. 1, continue in an upward slope. Under the PDUFA agreement, the fees for NDAs/BLAs are surging 25%. All but one of the MDUFA fees are going up 9.5%; the lone exception is growing by 18%. The MDUFA hikes are building on top of this year’s hefty increases. In the generics realm, the drug master file fee is going up 21%, but other fees increases are in the single digit range. Biosimilars, however, are the exception to the rule, with all the BsUFA fees seeing big drops.
In a balancing act between supply and drug quality, the U.S. FDA tipped the scales on behalf of quality, slapping an import alert on Intas Pharmaceuticals Ltd. in June, followed by a July 28 warning letter requiring the India-based company to develop and implement a global corrective action and preventive action plan.
A huge sigh of relief from the life sciences industry greeted U.S. President Joe Biden’s executive order that’s intended to shore up domestic manufacturing of products developed with taxpayer support. “It’s like the Titanic, [but] we just missed the iceberg,” Joseph Allen, executive director of the Bayh-Dole Coalition, told BioWorld. The fear for the past few years has been that the administration would follow in the wake of the Department of Energy, which broadly expanded the current Bayh-Dole U.S. manufacturing preference.
A huge sigh of relief from the life sciences industry greeted U.S. President Joe Biden’s executive order that’s intended to shore up domestic manufacturing of products developed with taxpayer support. “It’s like the Titanic, [but] we just missed the iceberg,” Joseph Allen, executive director of the Bayh-Dole Coalition, told BioWorld. The fear for the past few years has been that the administration would follow in the wake of the Department of Energy, which broadly expanded the current Bayh-Dole U.S. manufacturing preference.
Continuing its efforts to reduce prescription drug prices in the U.S., the Senate Finance Committee turned up the heat on pharmacy benefit managers (PBMs), voting overwhelmingly, 26-1, to send the bipartisan Modernizing and Ensuring PBM Accountability (MEPA) Act to the full Senate.
Following a comment-and-review process waylaid by the COVID-19 pandemic, the U.S. FTC is finalizing its revised guides on the use of endorsements and testimonials in advertising.
A British billionaire who’s the founder and principal owner of the Tavistock Group, an international private investment fund with a portfolio that includes biotech companies, was arrested July 26 on multiple criminal charges of U.S. securities fraud, along with two private pilots whom allegedly received insider tips from him in lieu of a formal retirement plan.
