The U.S. Congress passed a five-year reauthorization of the Medical Device User Fee Amendment (MDUFA) agreement, the fifth iteration of this user-fee agreement since the system's implementation in 2002, after many months of back and forth with the med-tech industry. The extension passed as part of a temporary spending bill needed to avoid a partial government shutdown ahead of Friday’s deadline. The spending bill passage gives lawmakers a reprieve until after the midterm elections when they'll need to figure out a longer-term funding plan for the fiscal year ending Sept. 30, 2023.
The notion that advances in artificial intelligence (AI) are a question of national economic competitiveness has been gaining currency of late, and a hearing in the U.S. House of Representatives lent more credence to the idea. Jordan Crenshaw of the U.S. Chamber of Commerce referred to the hazard of allowing dictatorships to set the standard for the use of AI as well as the ever-increasing global economic impact of these algorithms, adding that when it comes to AI, the U.S. is “in a race we must win” for both ethical and economic reasons.
U.S. lawmakers concerned about unconfirmed clinical benefit of drugs with accelerated approval got more fodder for their arguments in a new report from the Department of Health and Human Services Office of Inspector General (OIG). According to that report, which was released Sept. 29, Medicare and Medicaid have spent more than $18 billion over the past few years covering 18 drugs granted accelerated approval that haven’t completed their confirmatory trials even though the trial completion dates have passed.
Legislation to reauthorize a number of U.S. FDA user fee programs has once again languished until the 11th hour, but the House and Senate committees of jurisdiction have apparently come to terms over the matter. However, the parties to this deal are characterizing it as a “clean” bill, which suggests that FDA regulation of lab-developed tests (LDTs) and a center of drug manufacturing of excellence will have to wait for another day or – because of the upcoming mid-term elections – most likely another year.
Medical device manufacturers have railed against payers’ prior authorization practices for years, but the U.S. Congress seems poised to finally address the issue, at least in the context of Medicare Advantage (MA) plans. The House of Representatives has passed the Improving Seniors’ Timely Access to Care Act of 2021, a development that drew the applause of both the Medical Device Manufacturers Association (MDMA) and the American Society of Radiation Oncology (ASTRO), a clear display of the broad support enjoyed by the legislation.
With the science on aging advancing, it’s time for the U.S. to modernize its regulatory approval path for new longevity treatments, members of a House Science, Space and Technology subcommittee were told Sept. 15.
As expected, the U.S. House of Representatives passed, on a 220-207 party-line vote, a legislative package Aug. 12 that, for the first time, allows Medicare to directly negotiate some prescription drug prices, while imposing severe penalties and an excise tax on companies that refuse to negotiate or don’t comply with the government price.
The U.S. Senate and House of Representatives have not yet come to terms on FDA user fee legislation, a quinquennial source of melodrama that leaves the agency in an awkward position with current employees. However, FDA principal deputy commissioner Janet Woodcock said recently that prospective employees are also watching how Congress handles its business, adding that some of these pending hires may take jobs elsewhere rather than wait on Congress to send a user fee bill to the White House.
As Democrats in the U.S. Senate rush to pass prescription drug pricing reforms through the reconciliation process this week, the nonpartisan Information Technology & Innovation Foundation (ITIF) is offering Japan’s experience with government price controls as a cautionary tale.
As Democrats in the U.S. Senate rush to pass prescription drug pricing reforms through the reconciliation process this week, the nonpartisan Information Technology & Innovation Foundation (ITIF) is offering Japan’s experience with government price controls as a cautionary tale. “Stringent drug price controls have significantly hampered the competitive and innovative capacity of Japan’s biopharmaceutical industry in recent decades, serving as a warning for U.S. policymakers considering introducing Medicare Part D drug price controls in 2022,” according to the ITIF.
