Archive for July 2022

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…