Archive for March 2022
Adoption of Research Animals – State Policy
MichBio testified before the House Regulatory Reform Committee on HB 4881 and HB 4882, sponsored by Reps. Kevin Hertel (D-St. Clair Shore) and Tommy Brann (R-Wyoming) respectively, would require research facilities to offer dogs or cats used in laboratory research up for adoption prior to euthanizing them. Additionally, facilities would be required to submit annual…
Read MoreProposed Formation of Prescription Drug Affordability Board – State Policy
Sen. Brinks (D-Grand Rapids) and Rep. Camilleri (D-Trenton) introduced SB 889 and HB 5842, respectively that would establish a Prescription Drug Affordability Board (PDAB), similar to those already established in Colorado and Maryland. These bills, along with other companion bills, make up a package that would determine rates, set limits and cap how much up-charging can be done on…
Read MoreMichBio Supports Emphasis on Education and Talent Development – State Policy
MichBio co-signed a letter from the University Research Corridor (URC) and Michigan Association of State Universities (MASU) as part of a testimony package presented to the Senate Appropriations Subcommittee on Universities and Community Colleges by MASU Director, Dan Hurley. Michigan has an opportunity to do a great many things to set the course for long…
Read MoreRare Disease Advisory Council – State Policy
Legislation that proposes to establish a Rare Diseases Advisory Council, HB 4654, had a hearing by the Senate Health Policy Committee. MichBio reiterated its desire for some changes, particularly the inclusion of a representative from the Association or a Michigan biotech/pharma company working in rare diseases. A bill substitute containing such language and a few…
Read MoreBIO Releases Report on Policy Best Practices
BIO, in partnership with the CSBA, released a new report on bioscience economic development and legislative policy best practices, “Driving the Bioscience Economy Forward During the COVID-19 Pandemic: Best Practices in State and Regional Economic Development Initiatives.” The report, which reviewed public policy strategies and programs in all 50 states, highlights new and innovative initiatives…
Read MoreMichBio Joins to Decry CMS Coverage Decision
MichBio was part of a letter under the auspices of the Council of State Bioscience Associations (CSBA) to the Centers for Medicare and Medicaid Services (CMS) regarding the agency’s unprecedented National Coverage Determination (NCD) decision to limit seniors’ access to an entire class of Alzheimer’s drugs. A great op-ed by Dr. Michelle McMurry-Heath, President and…
Read MoreMichBio Signs on to Letter Opposing March-In Rights Petition
A petition was refiled with the federal government, in this instance with the Department of Health & Human Services, seeking to grant march-in rights for the patents on Xtandi, a prostate cancer drug, because of its alleged exorbitant price. March-in rights are rights granted to the federal government. These allow the government to grant patent…
Read MoreFDA User Fee Act Reauthorizations
The reauthorization process for the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Act (GDUFA), Biologic Drugs User Fee Act (BDUFA) and Medical Device User Fee Act (MDUFA) is underway. These run on a 5-year cycle and require Congressional enactment that authorizes the Food and Drug Administration (FDA) to collect user fees from…
Read MoreFDA Urges Companies to be ’Recall Ready’ to Protect Public Health as Part of Final Guidance for Voluntary Recalls
Original Source Today, the U.S. Food and Drug Administration finalized guidance to help companies prepare to quickly and effectively remove violative products from the market. The guidance describes steps companies should take, before a recall is necessary, to develop recall policies and procedures that include training, planning and record-keeping to reduce the time a recalled…
Read MoreKalamazoo lab filled COVID testing void. As cases wane, it eyes next step.
KALAMAZOO—Visitors to the city’s downtown pedestrian mall may not notice that a door to an important link in Michigan’s $28 billion life sciences industry is tucked into a busy parking deck. This office is where Genemarkers recognized during the early weeks of the COVID-19 pandemic that its lab, which performed R&D testing for skin care products, could turn…
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