March 26, 2019

March 26, 2019

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March 25, 2019

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DNA Sequencing Workshop and Drug Pricing Developments

In addition to covering a number of events related to the Affordable Care Act, telemedicine, and the nationwide opioid coverage crisis, this week’s Update covered the workshops held by the Food and Drug Administration (FDA) for genome scientists on the technical aspects of integrating Next-Generation Sequencing (NGS), a DNA-sequencing method, into clinical practice. 

While the FDA has not yet developed a new regulatory framework for NGS that is different from the process for more traditional diagnostic tests, its goal is to institute “appropriate oversight, in a way that is more suitable to the complexity and data-richness of this new technology.” This focus on NGS is being driven by President Obama’s Precision Medicine Initiative, bipartisan and bicameral interest on Capitol Hill, and the desire of patients and physicians to be able to choose the right treatment, at the right time, with hopefully minimal side effects. A number of federal agencies have taken steps to implement the Precision Medicine Initiative, including the National Institutes of Health which seeks to enroll one million volunteers in the next five years in a study that will evaluate the risk of developing a disease by looking at both genetic and environmental factors. The FDA workshop last week was also in step with the President’s initiative.

This week’s Update also highlights a number of developments related to prescription drugs:

1. President Obama reiterated his support for enabling the Department of Health and Human Services (HHS) to negotiate drug prices directly with manufacturer and is also looking at ways to prevent companies from raising prices of older drugs (which is a practice that has been the focus of criticism this year).

2. Last week, the Senate Special Committee on Aging, led by Senators Susan Collins (R-ME) and Claire McCaskill (D-MO), launched an investigation into price increases of certain drugs and sent letters requesting more information from Valeant Pharmaceuticals, Turing Pharmaceuticals, Retrophin, Inc., and Rodelis Therapeutics.

3. House Democrats announced an Affordable Drug Pricing Task Force designed to fight the rapidly increasing costs of pharmaceuticals. Members of this group are also urging House Oversight & Government Reform Chairman Jason Chaffetz (R-UT) to launch a formal investigation.

4. Today, HHS hosted an invite-only Drug Pricing Forum. The purpose of the forum is to address the impact of rising pharmaceutical costs and share information on how to address those rising costs while still encouraging innovation, strengthening incentives and promoting competition.

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About this Author

Samantha Kingsbury, Health Care, Attorney, Mintz Levin, Law firm
Associate

Samantha’s practice focuses on health care enforcement defense matters. These matters often involve criminal and administrative actions brought against health care providers and companies by state and federal governmental and regulatory agencies. She also has experience in assisting clients with internal investigations of potential violations of the federal anti-kickback statute, the Stark law, and the False Claims Act, among other statutes and regulations. Samantha also has experience preparing self-disclosures and other reports relating to such enforcement matters, as well as...

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