Policy News

President Biden signed into law the $280 billion CHIPS (Creating Helpful Incentives to Produce Semiconductors) and Science Act, a bill that would subsidize domestic semiconductor manufacturing and invest billions in science and technology innovation, in a bid to strengthen the United States’ competitiveness and self-reliance in what is seen as a keystone industry for economic and…

In the waning days before the August recess, Senate Democrats are pushing legislation with anti-science drug price controls, as part of a so-called reconciliation bill. The legislation could undercut its own goals by depriving drugmakers of incentives for developing blockbuster medicines, plus lower-cost biosimilars and generics, several analysts and industry groups have warned. Predictions are that…

Earlier this year, the Biden Administration aimed to reignite the Cancer Moonshot through its proposed federal budget and an objective to reduce cancer mortality by 50% over the next 25 years. The White House proposes to increase public funding for cancer research and at the same time control the price of cancer treatments. A University…

This podcast discusses the results of Vital Transformation’s latest research study outlining the impact of proposed changes to the Accelerated Approval pathway, and what this would mean for patients with rare conditions. The study quantifies the impact of the Accelerated Approval pathway in bringing new therapies for unmet needs to market, and the vital role…

MichBio is among over 400 groups from all 50 states that have signed the Prevent Cancer Foundation’s letter to Congress encouraging passage of the Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R. 1946 / S. 1873). The legislation has reached an exciting milestone with over half of the U.S. House of Representatives having co-sponsored the bill. As a reminder,…

Congress is considering several pieces of legislation requiring the FDA to regularly update cybersecurity guidance and better coordinate efforts with other agencies to better safeguard of medical and healthcare technologies from digital threats. A bipartisan proposal, the Strengthening Cybersecurity for Medical Devices Act, would require the agency to review and update premarket medical device cybersecurity guidance…

The Senate Commerce Committee passed legislation, Pharmacy Benefit Manager Transparency Act of 2022 (S. 4293) , that is designed to address how PBMs control drug prices and can potentially reduce the amount independent pharmacies and consumers pay for medicine. PBMs manage prescription drug benefits for insurance plans and payers. They receive rebates and discounts on…

Reauthorization of the FDA user fee agreement (UFA) package – that sets terms, conditions and costs for review of prescription drug (PDUFA), medical device (MDUFA), generic drug (GDUFA), and biosimilar (BsUFA) applications – is inching forward in Congress. In addition to codifying the agreements, these bills are often vehicles for other FDA policy changes. On…

The U.S. House Energy and Commerce (E&C) Health Subcommittee on Wednesday advanced to the full committee legislation reauthorizing user fee programs, including PDUFA and MDUFA. The legislation, H.R. 7667, the Food and Drug Amendment Act, passed 30-0 on a bipartisan vote with provisions to increase clinical trial diversity, modify the accelerated approval pathway and promote generics. On the…

May 2022 Update: In last month’s newsletter we informed that State Rep. Matt Koleszar asked the Michigan Attorney General (AG) for an opinion on the requirement to register facilities who use of animals in research and only permit those doing so in a “humane” manner. Due to several administrative reorganizations and transference of powers some…