BIO 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…

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MichBio 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…

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MichBio 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…

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FDA 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…

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MichBio Opposes Criminalization of Fetal Tissue Research

HB 5558, sponsored by Rep. Albert and others, was recently introduced and seeks that “Research shall not knowingly be performed on an organ, tissue, or cell taken from a dead embryo, fetus, or neonate obtained from an abortion.” This legislation is the latest attempt to criminalize and restrict fetal tissue research conducted legally and ethically.…

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Creation of Rare Disease Advisory Council Proposed

HB 4654, legislation to establish a Rare Disease Advisory Council (RDAC) within the Department of Health & Human Services has moved to the Senate for their consideration. Substitute language was introduced at the House Health Policy Committee that accommodated changes sought by MichBio. These included expanding the RDAC membership to include greater representation from the…

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Build Back Better Act to Impact Bio-Industry Negatively

The U.S. House on November 19 voted 220 to 212 to pass the “Build Back Better” Act (BBBA) reconciliation bill (H.R. 5376) that includes more than $1.5 trillion in business, international, and individual tax increase provisions. The legislation is now being debated in the Senate, initially by the Finance Committee It includes several drug pricing…

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New Federal Vaccine Mandate Details Issued – What Employers Must Know

UPDATE On Nov. 6, the U.S. Court of Appeals for Fifth Circuit issued an order staying implementation of the OSHA Emergency Temporary Standard (ETS) requiring mandatory vaccination or weekly testing requirements for employers with 100 or more workers. While the decision is stayed, employers do not have to comply with its terms. However, that stay…

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Dems close in on Medicare prescription drug negotiation compromise

Original Source Democrats are zeroing in on a deal to lower prescription drug prices that the party hopes it could add to President Joe Biden’s $1.75 trillion social spending bill as soon as Monday, according to sources familiar with the effort. The conversations involve a group of Senate Democrats, including Sen. Kyrsten Sinema of Arizona,…

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Menendez, Cassidy Introduce Legislation to Lower Drug Prices for Seniors

Bipartisan bill establishes a new out-of-pocket cap on catastrophic coverage, redesigns Medicare Part D benefits structure WASHINGTON, D.C. – U.S. Senators Bob Menendez (D-N.J.), and Bill Cassidy, M.D. (R-La.) today reintroduced the bipartisan Seniors Prescription Drug Relief Act to strengthen Medicare Part D and make it easier for seniors to afford their medication. “Our bipartisan bill would put…

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