ML Strategies

Over the course of 2020, the Food and Drug Administration (FDA) released numerous guidance documents covering diverse areas and aimed at increasing the availability of various medical products to prevent, treat, and diagnose COVID-19. Some of our prior blog posts on those pandemic response activities implemented by FDA can be found here and here. In all of those actions, FDA made clear that the agency’s enforcement discretion policy was temporary, or that an emergency use authorization (EUA) was being granted pursuant to statutory criteria that include a requirement that there be “no adequate, approved, and available alternative to the product,” which by definition renders the EUA temporary, as well. Accordingly, several EUAs granted to diagnostic tests, therapeutic products, and medical devices have been revoked based on a determination that all of the criteria necessary to support emergency authorization under the statute can no longer be met. And although the public health emergency is not over even as 2021 comes to a close, FDA has kept its promise to continually reassess circumstances and needs on the ground in the United States and to modify policies and emergency authorizations as necessary.

On Wednesday, September 1st, Attorney General Maura Healey certified 17 out of 30 ballot proposals filed in August to continue on the path to securing a spot on the 2022 ballot.  Of the 17 proposals certified, 16 were initiative petitions including, but not limited to, proposals relative to alcohol reforms, requirements for presentation of identification to vote, and the employment of app-based drivers.  The seventeenth proposal is a constitutional amendment providing for no-excuse absentee voting.

The second half of 2021 will be a busy stretch for Congress. In addition to the typical must-pass legislation, Democrats controlling both chambers and the White House are committed to several big spending bills, too. This preview is a rundown of these bills, what’s included in them, and how we can expect them to play out.

Those seeking to amend Massachusetts law or the Massachusetts Constitution through the state’s unique ballot initiative process had until Wednesday, August 4, 2021 to file their proposals with the Massachusetts Attorney General’s Office. By the time the deadline was reached, 30 proposals were filed.

Since the Democrats reclaimed control of the House of Representatives in 2018, barrels of ink have been spilled on the topic of “congressionally-directed spending”. Better known as earmarks, this funding mechanism allows Members of Congress to send money directly to projects identified in their districts, largely bypassing the federal bureaucracy and its protracted grant application process. For more than a decade, the Congress has banned the practice of including congressionally-directed funding in spending bills. Now, Democrats in control of both chambers and the White House are poised to bring earmarks back. On March 17th, House Republicans voted to reverse the GOP Conference’s ten year-old ban on congressionally directed spending, paving the way for Members from both parties to make requests in upcoming spending and infrastructure bills.

The 117th Congress kicked off its First Session with, among other initiatives, oversight hearings on the SolarWinds cyber hack.  On February 23, the Senate Intelligence Committee held a hearing on the high profile, far-reaching breach; followed by a joint hearing on February 26 in the House of Representatives held by the Oversight and Reform and Homeland Security Committees.  At both hearings, Sudhakar Ramakrishna, President and CEO of SolarWinds, Kevin Mandia, CEO of FireEye, and Brad Smith, President and Chief Legal Officer of Microsoft, testified.  In addition, George Kurtz, the President and CEO of Crowdstrike, testified at the Senate Intelligence hearing, while Kevin Thompson, the former CEO of SolarWinds, testified in front of the joint House hearing.  Together, the hearings represent what will likely be the first of several congressional forays into the SolarWinds hack, including possible legislative initiatives to address future possible incidents and supply chain security.

Last week, the Senate Committee on Health, Education, Labor, and Pensions voted 18-4 to advance Boston Mayor Marty Walsh’s nomination for labor secretary. The bipartisan approval signals a non-controversial confirmation vote of the full Senate. When that occurs, Secretary-designate Walsh will take over a department that is front and center in the nascent Biden administration. Executing White House priorities including the federal response to the COVID-19 pandemic, addressing the climate crisis, and reversing certain Trump era actions, will soon be Walsh’s responsibility. His experience in Massachusetts politics gives a sense of how Walsh will approach his new post.

With Democratic majorities in the U.S. House and U.S. Senate, Congress and President Biden’s new administration are working to quickly advance proposals to provide for economic relief as the nation continues to reel from the now nearly one-year pandemic. One area of emerging bipartisan focus is a long-sought measure to address the nation’s crumbling and outdated infrastructure, which could be paired with a required surface transportation reauthorization bill.

After what felt like one of the longest election seasons in history, Washington is preparing to welcome the incoming administration of President-elect Joe Biden and Vice President-elect Kamala Harris. Meanwhile, Capitol Hill adjusts to a dramatic shift in power as Democrats achieved an election night stunner by winning both Senate run-off elections in Georgia on January 5, sending Rev. Raphael Warnock and Jon Ossoff to Washington and giving Democrats a 50-seat majority with the new incoming vice president casting any tie votes. In the House of Representatives, Republicans narrowed the Democrats’ majority in November but are still in the minority and Rep. Nancy Pelosi (D-CA) has been reelected to serve as Speaker of the House.

Politics will have an effect on FDA policies in 2021, including with respect to the ongoing COVID-19 response, manufacturing, compliance, digital health, laboratories, user fees, device servicing, and more.

What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was thrust into the public eye amidst the COVID-19 pandemic. This was the year many Americans became familiar with lesser-known and niche policies like those governing emergency use authorizations (EUAs) and with the role of FDA in regulating laboratory developed tests (LDTs). The agency also took some flak for seeming to bow to political pressure in authorizing hydroxychloroquine for emergency use as a potential COVID-19 treatment, then rescinding the authorization, as well as for its less-than-accurate pronouncements of positive data concerning convalescent plasma treatment. These were reminders that the agency Americans trust to protect the public does get things wrong sometimes and is susceptible in some ways to political pressure, and that effectively ensuring the public health requires a balance between safety and effectiveness and patient access to medical products. As we look ahead, we eagerly anticipate how FDA will protect and promote public health in a Biden administration. In this post we’ll explore the FDA’s device law and policy activities from 2020.

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.