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Snapshot of Another Much-Too-Busy Year for FDA Before 2022 Really Gets Started

January 5, 2022 | Blog | By Joanne Hawana, Benjamin Zegarelli

It is, somewhat amazingly, the beginning of January again. During this time of year we typically publish a series of blog posts that recap the most interesting Food and Drug Administration (FDA) activities over the prior 12 months and consider what the agency is likely to focus on going forward. This year, however, we’re taking a different approach and will be providing more of a birds-eye view of our favorite federal agency as it stands as of the end of 2021. Because there is just too much going on at the administrative, enforcement, and legislative levels to get into the details of everything in one fell swoop. So make sure you’re signed up for Mintz Health Law Viewpoints to receive updates throughout the year on issues as they develop.
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On December 22, 2021, FDA took another step in rolling back enforcement policies implemented in response to the COVID-19 pandemic by publishing guidance documents describing the regulatory requirements for devices that were authorized under the emergency use authorization process and those under temporary FDA policies implementing specific enforcement discretion during the pandemic once the Public Health Emergency for COVID-19 ends. The Transition Plan Guidances will help device manufacturers prepare for the end of the PHE and continue to commercialize devices necessary for the long-term response to COVID-19.
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Webinar Recording: Telehealth Regulation & Enforcement: 2021 Year in Review & 2022 Outlook

December 7, 2021 | Webinar | By Alexander Hecht, Ellen Janos, Karen Lovitch, Kate Stewart

Over the past year, the demand for health care via telehealth has continued to skyrocket as a result of the COVID-19 pandemic and the public’s increased comfort with obtaining health care goods and services virtually. Join Ellen Janos, Karen Lovitch, Kate Stewart and Alex Hecht as they demystify the current status of laws and regulations, untangle the web of legislation before Congress related to the expansion of telehealth services, discuss recent enforcement activity, and look ahead to trends we see on the horizon.  
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Energy & Sustainability Washington Updates - December 2021

November 30, 2021 | Blog | By R. Neal Martin

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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.
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House Democrats Weigh Major Tax Changes for Businesses, Funds, and Individuals

October 12, 2021 | Alert | By Gregg M. Benson, Anthony DeMaio

Read about the U.S. House Ways and Means Committee’s proposed tax legislation intended to partially fund the $3.5 trillion Build Back Better Act to fund Democratic priorities.
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Proposed Laws Are One Step Closer to the November 2022 Ballot

September 3, 2021 | Blog | By Steven Baddour, Daniel Connelly, Caitlin Beresin, Kaitlyn Sprague, Taylor Shepherd

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.
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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.
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New Laws Possible in Massachusetts - Proponents Set Sights on 2022 Ballot

August 6, 2021 | Blog | By Steven Baddour, Daniel Connelly, Caitlin Beresin, Kaitlyn Sprague, Taylor Shepherd

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.
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Energy & Sustainability Washington Updates - August 2021

August 2, 2021 | Blog | By R. Neal Martin

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Energy & Sustainability Washington Updates - July 2021

July 16, 2021 | Blog | By R. Neal Martin

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Cyber Policy Legislative Tracker

May 5, 2021 | Resources | By Alexander Hecht, Christian Tamotsu Fjeld

The bills listed reflect a relatively active cybersecurity agenda for the 117th Congress.  As reflected in the proposed legislation, many Members are interested in focusing federal policy on matters such as supply chain security, cyber workforce training, and international competitiveness, particularly with China.  The most ambitious bill may be the Endless Frontiers Act, which would establish a Directorate for Technology and Innovation within the National Science Foundation and further establish regional hubs (i.e., partnerships between government, private, and academic stakeholders) to drive R&D and commercial innovation in key areas of technology.  Endless Frontiers could be the centerpiece of a legislative agenda to ramp up the U.S.’s technological competitiveness with China.  The Senate Commerce Committee was scheduled to mark-up the bill last Wednesday, but it was pulled after over 230 amendments were reportedly filed, and Members failed to garner a critical mass of bipartisan support.  The committee will likely work through the recess to seek bipartisan agreement for passage. 
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House Republicans Reverse Course on Earmarks, Congressionally Directed Spending is Back

March 18, 2021 | Blog | By Frank C. Guinta, Anthony DeMaio

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.
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Hearings on the SolarWinds Hack and Possible Policy Responses

March 4, 2021 | Blog | By Christian Tamotsu Fjeld

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.
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As Walsh Awaits Confirmation Vote, DOL Priorities Take Shape

February 16, 2021 | Blog | By Anthony DeMaio, R. Neal Martin

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.
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Transportation & Infrastructure: What to Expect from the Biden Administration & 117th Congress

February 4, 2021 | Blog | By Christian Tamotsu Fjeld, R. Neal Martin, Anthony DeMaio

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.
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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.
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Action Items on Technology and Communication Policies in front of the Senate Commerce Committee

January 14, 2021 | Blog | By Christian Tamotsu Fjeld, Christopher Harvie

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Looking Ahead: FDA in 2021

January 8, 2021 | Blog

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.
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