Archive for May 2023

HB 4409, the “Drug Manufacturer Data Reporting Act” was introduced recently by Rep. Steckloff (D-MI-19), as an attempt to seek more transparency and control of drug prices. The bill would require biotech/pharma companies to provide information on a range of expenses including R&D, marketing, clinical development, whether and how much the company received in federal…

Rep. Jason Morgan (D- MI-23) introduced HB 4167 late February, the latest attempt to establish a Rare Disease Advisory Council (RDAC) in Michigan. A RDAC would empower rare disease patients as partners in helping to shape policy development relevant to the unmet needs, common struggles, and concerns on equitable, quality, and affordable access to specialty…

The House Financial Services Committee, in a marathon session late April, considered a package of 15 bills designed to relieve regulatory burdens and facilitate access to needed capital for biotech startups. Among them were the following: The Equal Opportunity for All Investors Act,which would create a certification exam to qualify as an accredited investor so more…

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…