Archive for April 2022

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…

The Advanced Medical Technology Association (AdvaMed) announced its  revised Code of Ethics on Interactions with Health Care Professionals (HCPs)on March 18, 2022. The medical device industry has relied on the AdvaMed Code for decades to assist with navigating complex rules concerning compliance—particularly rules regarding fraud and abuse stemming from interactions with HCPs. Notable updates to the…

Last month, we wrote that MichBio signed on to a letter opposing the Centers for Medicare and Medicaid Services (CMS) unprecedented draft National Coverage Determination (NCD) decision to limit seniors’ access to an entire class of Alzheimer’s drugs. On April 7, CMS released a final decision to limit coverage only to people who receive Aduhelm™…

As noted in last month’s update, the process behind developing a new Medical Device User Fee Amendments (MDUFA) has been a slow slog. The current MDUFA IV is set to expire at the end of September 2022 and must be reauthorized by Congress before then or the FDA will have to cease product reviews and…

MichBio was privileged to moderate a Congressional briefing on H.R. 6000, the Cures 2.0 legislation. Several other state groups including BioNJ, Health Institute of New Jersey, California Life Sciences, Life Sciences PA, and Biocom California partnered to co-host the event. The over 125 attendees heard directly from the featured guests and bill’s sponsors, Michigan’s Rep.…

U.S. Representative Fred Upton (R-6) announced that the current term would be his last, and he will not run for re-election in November 2022. First elected in 1987, Fred (as he always asked anyone to call him) previously served on the House GOP’s leadership steering committee and chaired the powerful Energy and Commerce Committee. Additionally,…

The SBIR/STTR Programs are currently set to expire on September 30, 2022. It would be damaging to American innovation and competitiveness if these programs were to expire before a full reauthorization can be passed. The SBIR/STTR Programs enable small businesses to develop and commercialize new innovative technologies and have a proven track record of promoting competition through…