Archive for February 2023

Giving a voice to the one million Michiganders with a rare disease.   February 27, 2023 – Lansing, MI – Representative Jason Morgan (D) Ann Arbor to introduce legislation to establish a Rare Disease Advisory Council (RDAC) in Michigan. The council will gather stakeholders from the patient community, the life sciences industry, health insurance, provider…

The Biden administration, via its Office of Science & Technology Policy (OSTP) requested input recently on implementing the new National Biotechnology and Biomanufacturing Initiative. BIO (Biotechnology Innovation Organization, of which MichBio is a state affiliate), responded with recommendations, which include, among others: Reduce trade barriers that interfere with the biotech supply chain. Increase capacity for surges in manufacturing to enhance…

The USPTO and FDA held a joint listening session focused on the patent system for drugs. Speakers from patient advocacy and industry groups, academia, and brand and generic pharmaceutical companies weighed in on the relationship between patents and affordable access to medicines. The session stemmed from a joint July 2022 announcement that the two agencies…

CMS has posted an Information Collection Request (ICR) on the Small Biotech Exception to the Medicare drug pricing negotiation program established under the “Inflation Reduction Act” just passed by the last Congress in late 2022. Comments must be received by March 27.

AdvaMed President and CEO, Scott Whitaker, recently sent a letter to President Biden outlining concerns about how more stringent ethylene oxide (EtO) requirements could stop medical devices from reaching patients. “With 20 billion medical devices sterilized using EtO each year in the U.S. at about only 100 facilities, the closure of even a small percentage…

The Food and Drug Administration (FDA) released a statement indicating the need for a new regulatory pathway to allow for greater oversight and to better manage risks associated with cannabidiol (CBD) products, including products currently marketed as conventional foods and dietary supplements as well as products marketed for animal use. Few details were provided about the proposed…

Michigan’s new legislative session for the 2023-24 term is off and running. Turnover in the Michigan House is 52%, whereas the Senate is home to 16 new members (a 45% turnover). Leadership are now in place for both parties, as are committee assignments, with the Democrats in the majority in both chambers for the first…