ML Strategies

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.

The Baker Administration, along with prioritizing the medial professionals on the front lines of the fight against the novel coronavirus (“COVID-19”), have taken significant steps to relieve pressures on small businesses negatively impacted by the virus.  Most notably, opportunities through the Small Business Administration’s (“SBA”) Economic Injury Disaster Loan program and other tax relief for small businesses including those in the restaurant and hospitality sectors.

On Wednesday, key Members of the House of Representatives sent a letter to the Chairman of the Federal Trade Commission (FTC), urging the Commission “to take immediate action to protect consumers from price gouging during this [COVID-19] declared public emergency.”  The letter was sent to FTC Chairman Joseph Simons from the chairs of the committees and subcommittees with jurisdiction over the FTC:

As we write this update on the actions of the Food and Drug Administration (FDA), more state and local governments (along with private businesses and employers) are taking sweeping actions to protect the public from the continued spread of COVID-19. The federal response to what is now a pandemic of COVID-19 started off slowly, but we are now seeing frequent and promising announcements from FDA and other agencies within the Department of Health and Human Services.

We published our first installment highlighting FDA’s role in this public health emergency on March 4, 2020 (see our prior post here). In the two weeks that have elapsed since then, FDA has taken several actions related to COVID-19 testing and other important public health protections which are explained below. One of the most striking things about the list of actions included in this post may be how diverse and broad FDA’s authorities are and what a substantial role the agency plays in protecting Americans from a variety of different types of harm.

Read about the federal government’s response to COVID-19, including $8B in emergency funding and the Families First Coronavirus Response Act pending in the House.

The Baker Administration continues to monitor the COVID-19 public health crisis, expanding almost daily on restrictions for schools, restaurants and several other places of business across the Commonwealth.  As these updates are constantly evolving, this post is meant to provide the most up to date announcements.

Following years of discussion, on March 5, 2020, U.S. Representatives Larry Buchson (R-IN) and Diana DeGette (D-CO) and U.S. Senators Richard Burr (R-NC) and Michael Bennet (D-CO) introduced identical versions of the Verifying Accurate and Leading-edge IVCT Development (VALID) Act in both chambers of Congress. The bipartisan legislation closely tracks existing medical device laws, with some notable exceptions, discussed below and in a prior post. If enacted, many regulatory elements familiar to in vitro diagnostic (IVD) and other medical device manufacturers would be applied to clinical laboratories that develop their own tests, commonly known as laboratory developed tests (LDTs). The bill also includes elements that are priorities for the Food and Drug Administration (FDA), including a program conceptually similar to pre-certification, third-party review, and Collaborative Communities. Unlike previously-circulated discussion drafts, the introduced bills include specific language designed to address public health emergencies, including COVID-19.

As the nation continues to address the spread of the novel coronavirus (“COVID-19”), several precautionary efforts are being taken to ensure citizens remain safe and reduce the prevalence of transmission to vulnerable individuals across the country.  As the Legislature and Executive Branch aggressively focus on COVID-19 related issues, your ML Strategies team will continue to monitor and engage state and local leaders on legislative and regulatory priorities by keeping lines of communication open on a daily basis with legislators and staff.

Within the U.S. Department of Health and Human Services (HHS), many agencies have responsibility for responding to public health emergencies. The Centers for Disease Control and Prevention (CDC), as its name implies, is at the forefront of the COVID-19 (coronavirus) outbreak as the government seeks to control and prevent the spread of the virus in the United States. The National Institutes of Health (NIH), particularly the National Institute of Allergy and Infectious Diseases, are also involved, primarily conducting research into the sources, cause, and means of transmission of the new virus and coordinating vaccine development efforts. The Food and Drug Administration (FDA) is responsible for assuring the safety and effectiveness of medical products and therefore has oversight over any clinical trials for promising coronavirus treatments (drugs, vaccines, devices), as well as authority to authorize the marketing of any such product. The agency oversees the drug supply chain and monitors drug and device shortages. This blog post covers steps that FDA has taken to mitigate potential drug and device shortages related to coronavirus and to otherwise respond to the coronavirus situation.

ML Strategies’ 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.

Christian Fjeld, Vice President of ML Strategies, discusses the possibility of future legislation addressing ethical considerations surrounding artificial intelligence. Christian explains that it will most likely be the courts that determine parameters on AI ethics in society with decisions on individual cases. 

ML Strategies’ Christian Fjeld discusses Senator Wyden’s Algorithmic Accountability Act which would direct the Federal Trade Commission to promulgate rules that would establish how companies should assess their algorithmic decision making to ensure that it is not biased or discriminating against classes of people.

On Tuesday, February 11, 2020, Senators Bill Cassidy (R-LA), Jeanne Shaheen (D-NH), and Tammy Baldwin (D-WI) introduced legislation to eliminate the “orphan drug loophole.” Current law allows the Food and Drug Administration (FDA) to grant seven years of market exclusivity to a drug manufacturer if the drug is intended to treat a disease or condition affecting fewer than 200,000 patients in the U.S., or less commonly, if the manufacturer cannot expect to recover the costs of developing and marketing a drug. In some cases, even if the drug developer meets the orphan drug criterion of having no hope of recovering the costs, the drug does actually become profitable—some significantly so—but competitors are still barred from entering the market with a lower-cost alternative during the 7-year exclusivity period that exists by operation of law. To combat this issue, the recently introduced Senate bill (as well as a nearly-identical House bill introduced in October 2019) targets a loophole that allows market exclusivity under the Orphan Drug Act to be extended for future versions of the same drug without the drug's manufacturer having to show that the drug remains unprofitable.

In this video, Aaron Josephson discusses FDA user fee agreements, the timeline for the reauthorization process, and why it is important for companies with FDA-regulated products to be paying attention now.

As discussed in an earlier blog post, the process for reauthorizing human medical product user fee programs at the Food and Drug Administration (FDA) for another 5-year period is getting started this year. Below we highlight some changes made to the programs when they were last reauthorized through the 2017 Food and Drug Administration Reauthorization Act (FDARA) (P.L. 115-52) and consider what could be included in the upcoming user fee reauthorization package.

Read the transcript of a San Francisco Business Times panel discussion on artificial intelligence, including ML Strategies Vice President Christian T. Fjeld’s insights on emerging regulatory issues.

A history of FDA human medical product user fee programs, including those for prescription drugs (PDUFA), generic drugs (GDUFA), biosimilars (BsUFA), and medical devices (MDUFA), their negotiation and reauthorization, and how manufacturers and patients can participate and get involved in the negotiations.

As we noted in our previous blog post, there are several legislative priorities in the health care space that could see action this year. There are also a variety of activities beginning this year that could set the stage for later action. Here’s what we’re tracking for a 2020 health care legislative package.

On December 20, 2019, the President signed into law a bill to fund the federal government through September 30, 2020. The bill included several important health care provisions but left some longstanding policy challenges unresolved. Most notable changes to law are the elimination of three Affordable Care Act taxes and the passage of the CREATES Act. Noticeably absent is legislation related to surprise billing and prescription drug pricing. A summary of key health care provisions included in the 2020 Consolidated Appropriations Act (P.L. 116-94) follows. We will address the legislative outlook for 2020 in a separate ML Strategies blog post next week.

As the Legislature approaches the Holiday recess, health care costs and access continue to be at the forefront of the agenda. The Baker Administration released the VALUE Act on October 18th and the Senate filed the PACT Act on November 7th.