Life Sciences & MedTech

Read about the BIOSECURE Act, its legislative path, and the broader context of critical end-of-year negotiations shaping the priorities of the 118th Congress.

On March 18, President Biden signed an executive order (EO) that contributes to the administration’s objective to create solutions to long-lasting women’s health issues that have been historically understudied and under-evaluated.

Read about Sprint for Women’s Health, a first-of-its-kind initiative to commit $100 million for research and development in women’s health, announced by the Advanced Research Projects Agency for Health.

Aaron Josephson explains why FDA is looking to Collaborative Communities to help solve challenges in 2020 and the potential benefit to companies who participate in the development of public policy.

In our first two Device Modernization series posts, we discussed FDA’s 510(k) modernization efforts and the proposed De Novo regulation. FDA has also had a heavy hand in legislative efforts to retool oversight of laboratory developed tests (LDTs) and other in vitro diagnostics (IVDs). The proposed approach would create an entirely new category of medical product separate from medical devices known as in vitro clinical tests (IVCTs).

On March 5, 2019, FDA Commissioner Scott Gottlieb announced his resignation. The physician and venture capitalist, ​for whom this was ​a second stint at the FDA, intends to leave the agency in about a month to spend more time with his family. In this post, Aaron Josephson reflects on Dr. Gottlieb's time leading the FDA and its future after his departure.

In our first Device Modernization series post, we discussed how FDA is proposing to modernize the 510(k) review program. FDA also recently issued a proposed regulation for the De Novo program and linked that proposed regulation to 510(k) modernization efforts as part of a broader strategy to improve device safety.

On Tuesday, executives from seven of the largest pharmaceutical companies testified before the Senate Finance Committee on rising prescription drug prices. While the hearing was expected to be packed with fireworks as Senators of both parties grilled the nation's top pharmaceutical executives, it was largely uneventful. 

In our “FDA 2018 Year in Review (and a Few Thoughts on 2019)” post and recent webinar, we observed that we may look back at 2018 as the beginning of the end for the 510(k) program as it has existed since the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. The 510(k) pathway has been scrutinized for years and among the most damning criticisms leveled against it is that it is a loophole that lets unsafe products on the market by allowing manufacturers to, in most cases, avoid clinical testing.

Mintz/ML Strategies’ 4th Annual Pharmacy & Pharmaceutical Industry Summit has been scheduled for Thursday, May 2, 2019 – mark your calendars!

As of December 2018, 37 states (including D.C.) have adopted Medicaid expansion. Of the remaining 14 states, some are considering expanding Medicaid. States with recent activity relating to Medicaid expansion include: Florida, Idaho, Maine, Missouri, Nebraska, New Hampshire, North Carolina, and Utah. States continue to explore different opportunities as it relates to Medicaid expansion. 

On Tuesday, June 19, 2018, the Massachusetts House of Representatives passed comprehensive health care legislation by a vote of 117-32.

With the end of the 2017-2018 legislative cycle fast approaching, Beacon Hill’s agenda for the coming months has begun to take shape. All major policymaking will need to be concluded by the end of formal sessions on July 31, and lawmakers have a long to-do list they hope to complete before that date.

The Cannabis Control Commission (CCC) voted in late December to approve draft regulations establishing the framework for the recreational marijuana industry of Massachusetts.