ML Strategies

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. 

This week, Congress is working towards passage of a continuing resolution that would fund the government through the middle of November. This will give policymakers and appropriators enough time to hash out differences in funding priorities as well as work on policies addressing drug pricing, surprise billing, and funding for public health programs. The surprise billing issue is really heating up with outside stakeholder groups weighing in and Congress carefully considering its next steps. We cover this and more in this week's preview, which you can find by clicking here.

With less than a year to go until the end of formal sessions on July 31, 2020, Massachusetts legislators are back in action this month to begin tackling a robust policy agenda. We are poised to see action on both new and pending legislation this fall on a number of priority policy areas.

As August recess gets underway for the House and the Senate, ML Strategies has prepared a summary of the status of this summer’s key cybersecurity issues. ML Strategies will continue to track these and other cybersecurity priorities before Congress and the Administration through August and beyond.

This week, the Senate is expected to vote on a budget deal that would also suspend the debt limit for two years. This clears a major hurdle come September when both chambers of Congress will be in session with a laundry list of policies and programs to address, including appropriations. We cover this and more in this week's preview, which you can find by clicking here.