ML Strategies

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.

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.

Responding to increased public and congressional criticism of its arguably too-flexible approach to regulatory oversight of serological tests used to detect COVID-19 antibodies, on May 4, 2020 the Food and Drug Administration (FDA) announced a revised policy aimed at reducing the risks associated with such tests.

Economists create graphs, charts and projections on the economy daily, crafting commentary to explain the ebbs and flows of market success and failures based on a variety of factors. That is no longer the case as the nation battles the novel coronavirus (“COVID-19”). Economist’s projections are at the mercy of the raging virus as many states enter “the surge”, compromising health care systems, learning institutions and local economies nationwide.

As the coronavirus pandemic spreads across the nation, your team at ML Strategies continues to monitor legislative and regulatory updates at the federal and state level. Each week, ML Strategies will provide weekly updates from Massachusetts and Washington, DC to keep you informed and aware of relief opportunities and guidance for your businesses and companies.

This week, Governor Charlie Baker issued COVID-19 Order No. 19, “Order Regarding the Conduct of Shareholder Meetings by Public Companies.  This Order, which is effective immediately, suspends certain requirements of M.G.L. chapter 156D, section 7.08 that relate to shareholder meetings by remote means.

Governor Charlie Baker just announced he is extending his executive order that mandates the closure of non-essential businesses.

Two weeks ago, on March 9, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) sent warning letters to seven companies that allegedly made false or deceptive claims about their products’ ability to treat Coronavirus Disease 2019 (COVID-19).  The agencies warned the companies that their health claims lacked credible supporting evidence and emphasized the FDA does not recognize a vaccine, drug, or treatment for the disease.  

The response to the coronavirus situation is fluid and fast-moving – particularly by Congress’ standards.  In response to the coronavirus pandemic, three phases of legislation have been considered in Congress: Coronavirus Supplemental Appropriations Act (signed into law March 6th); Families First Coronavirus Response Act (signed into law March 18th); and a large ($1 trillion+) economic recovery package (currently being drafted). This post provides details about these legislative efforts and other recent actions by the White House to address the coronavirus pandemic.