ML Strategies

The fiscal year 2021 (“FY2021”) budget process has been anything but typical. Shortly after Governor Baker’s budget proposal was released in January, the COVID-19 pandemic struck, reorienting the legislative calendar for the remainder of the 2019-2020 legislative session.

With the presidential transition underway, we now look forward to what the Biden administration will seek to accomplish, particularly in the realm of health care policy.

Read about the post-election impact on international trade matters and the incoming administration's influence on the Committee on Foreign Investments in the U.S. (CFIUS).

Read about the Massachusetts congressional delegation to the 117th Congress, their current and potential committee assignments, and possible policy implications.

Read about how the administration of President-Elect Joe Biden could shape clean tech, energy, and environmental policy in a divided government.

You’d be forgiven in the current climate of coronavirus and election season, to name just a couple hot issues of the day, for missing two recent announcements from the FDA about its digital health program. On September 14, 2020, FDA published “Developing the Software Precertification Program: Summary of Learnings and Ongoing Activities” and the following week, on September 22, launched the Digital Health Center of Excellence.

Despite the COVID-19 pandemic, the House Energy & Commerce Committee continues work on several health policy issues, including Orphan Drug Act reform and continuous manufacturing.

Today, the Baker-Polito Administration’s Reopening Advisory Board published their report outlining a 4-phase schedule for reopening the Commonwealth since the closure of non-essential businesses on March 23.

This update covers federal and Massachusetts responses to the pandemic, including the House Democrats’ phase 4 economic stimulus proposal, the SBA’s report on PPP implementation plus criticism of how it manages EIDL, and Massachusetts’s reopening plan and its proposed $1B supplemental budget to cover Covid-19 spending.

This update covers federal and Massachusetts responses to the pandemic, including the U.S. Treasury Implementation of CARES Act programs, new proposals for small- and mid-sized businesses, the Paycheck Protection Program (PPP), and new Massachusetts rules related to masks, car dealers, and retailers.

On Monday, April 27, Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) announced the next steps for 21st Century Cures 2.0 (Cures 2.0), legislation that will build on the original 21st Century Cures Act enacted in December 2016 (Cures 1.0). While Cures 1.0 aimed to speed up the process of bringing new treatments to market, Cures 2.0 is generally envisioned to emphasize public health and streamlined care delivery, particularly in light of the COVID-19 pandemic. Elements envisioned to be in Cures 2.0 were outlined in a recently published concept paper that we discuss in this post.