Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


FDA Considers Rulemaking to Overhaul Diagnostics Regulations

Food and Drug Administration (FDA) officials have suggested in recent weeks that the agency may use its rulemaking authority to overhaul the regulation of diagnostics and laboratory-developed tests (LDTs) if Congress fails to do so before the end of the year. Lawmakers are considering the inclusion of the Verifying Accurate Leading-edge IVCT Development (VALID) Act (S. 2209/H.R. 4128) in an end of the year package after it was dropped from the medical product user fee reauthorization included in the Continuing Resolution (CR) passed last month. Commissioner of Food and Drugs Robert Califf and Center for Devices and Radiological Health Director Jeff Shuren have expressed support for the approach taken in the VALID Act and stated last week that federal rulemaking “is always an option” if the legislation is not successfully passed by Congress before adjournment.

HELP Committee GOP Release Report on COVID-19 Origin

Republicans on the Senate Health, Education, Labor, and Pensions (HELP) Committee released an interim report last week considering the theory that the COVID-19 pandemic originated from a laboratory leak. The report summarizes publicly available, open-source information related to the potential origin of SARS-CoV-2. HELP Committee Ranking Member Richard Burr (R-N.C.) has said that he hopes the report will guide international institutions and researchers, congressional Democrats, and the Biden administration in further investigating the origin of the virus, while acknowledging that there is a lack of indisputable evidence to support findings that COVID-19 started in a lab. Committee Chair Patty Murray (D-Wash.) has underscored her commitment to investigating the origins of COVID-19, stating that this effort is included as a part of the bipartisan pandemic preparedness package (S. 3799) advanced by the panel in March.

Wegrzyn Makes First Official Remarks at ARPA-H Launch Event

The Biden administration held a launch event for the new Advanced Research Projects Agency for Health (ARPA-H) last week. During the event, Director Renee Wegrzyn stressed the importance of making ARPA-H’s discoveries widely accessible and affordable starting from their early phases of development. Wegrzyn aims to build equity into the new agency’s processes and make ARPA-H’s discoveries scalable and applicable to multiple diseases and conditions. She said that her top priority will be hiring program managers who have a clear vision for a specific problem that needs to be addressed.

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