Policy News

Reps. Buddy Carter (R-GA) and Carol Miller (R-WV) reintroduced the Manufacturing API, Drugs, and Excipients (MADE) In America Act to prevent U.S. pharmaceutical supply chain dependence on China and other foreign adversaries. The MADE in America Act will stimulate domestic manufacturing of drugs and pharmaceutical supplies such as active pharmaceutical ingredients (API) and personal protective…

The Senate HELP Committee is taking up four bills – S 1607 (Ensuring Timely Access to Generics Act of 2023), S 1214 (Retaining Access and Restoring Exclusivity Act of 2023), S 1114 (Expanding Access to Low-Cost Generics Act of 2023), and S 1339 (Pharmacy Benefit Manager Reform Act) – introduced with a focus on regulating drug…

Medical device sterilizers will face new limits on ethylene oxide (EtO) emissions and new requirements for worker protection, according to a pair of proposals issued by the EPA. The new limits are part of a broader series of actions by the agency to reduce exposure to the chemical, which it said can increase cancer risks…

The America Innovation and R&D Competitiveness Act of 2023 was reintroduced that would repeal current rules and allow a business to deduct of R&D costs in the tax year that they occur and thereby incentivize long-term investments in innovation. Such repeal has been a top policy priority for MichBio and the bio-industry generally as it would…

Spring in Washington, DC annually witnesses the ritual of Legislative Fly-Ins whereby many special interest groups descend on Capitol Hill to advocate their policy priorities. This year was no different, except for the fact that it was the first time such pilgrimages were made in three years due to the pandemic. MichBio made two trips…

MichBio, like many other stakeholders in the life sciences industry, has serious concerns over the recent Texas Court decision to suspend the FDA approval of abortion pill mifepristone and what it may mean more broadly for the FDA’s ability to regulate drug reviews and approval. The decision, should it stand upon appeal, would set a…

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.