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.


E&C Advances FDA User Fee, Mental Health Packages

The House Energy and Commerce Committee advanced six health care bills to the floor last week. A must-pass package, the Food and Drug Amendments of 2022 (H.R. 7667), reauthorizing medical product user fee programs at the Food and Drug Administration (FDA) for another five years was approved by a bipartisan 55-0 vote. The panel agreed to an amendment from Rep. G.K. Butterfield (D-N.C.) based on his Give Kids a Chance Act (H.R 6972), which would give FDA the authority to require that manufacturers investigating a drug combination targeting adult cancer also develop a pediatric study plan to inform labeling for children. The current user fee agreements expire on September 30.

The committee also advanced comprehensive mental health legislation (H.R. 7666) by voice vote. The Restoring Hope for Mental Health and Well-Being Act aims to address the nation’s worsening overdoses crisis by increasing funding for and access to mental health services. It would also renew several mental health programs. During the markup, the panel adopted an amendment to the bill that would add training requirements for prescribers of controlled substances.

The ARPA-H Act (H.R. 5585) was advanced by a vote of 53-3. The bipartisan bill would authorize the new biomedical innovation hub known as the Advanced Research Projects Agency for Health (ARPA-H) as an independent agency within the U.S. Department of Health and Human Services (HHS). The ARPA-H director would be subject to presidential appointment and Senate confirmation. The legislation, which would prohibit ARPA-H’s headquarters from sitting on any part of the existing National Institutes of Health (NIH) campuses, would conflict with steps already taken by HHS Secretary Xavier Becerra to establish ARPA-H as an agency inside NIH. The House bill would provide HHS six months to transfer ARPA-H into an independent operating division. The Senate’s ARPA-H authorizing language, contained in the PREVENT Pandemics Act (S. 3799), would place ARPA-H within the NIH but require the agency to be headquartered outside the national capital region. Lawmakers have already begun pressing the administration to choose their state for the placement of ARPA-H, with Massachusetts’ and Texas’ congressional delegations both reportedly lobbying Secretary Becerra to headquarter ARPA-H within their states. During the Reagan-Udall Foundation for the FDA annual public meeting held last week, FDA Principal Deputy Commission Janet Woodcock previewed how the agency will interact with the newly established ARPA-H. Woodcock stated that the FDA will be “deeply involved” in the work of ARPA-H, but that the new biomedical research agency may intensify the recent debate around the accelerated approval process and the appropriate balance between the certainty of a product’s clinical benefit and the speed of access to patients in FDA’s review of future ARPA-H discoveries.

HELP Releases Draft FDA UFA Package

Leadership of the Senate Health, Education, Labor, and Pensions (HELP) Committee released their bipartisan discussion draft, the FDA Safety and Landmark Advancements (FDASLA) Act, to reauthorize the medical product user fee programs at the Food and Drug Administration (FDA) for another five years last week. The package would also expand the agency’s authority over how cosmetics, dietary supplements, and laboratory-developed tests (LDTs) are regulated. It includes provisions from the Dietary Supplement Listing Act (S. 4090) that would require manufacturers and distributors of dietary supplements to register their products with the FDA. It would also require makers of cosmetic products to register with the FDA and would provide the agency with the authority to discontinue products with harmful ingredients. The VALID Act, which would reform the way the FDA regulates diagnostic tests, is also included in the package. In response to the FDA and medical device industry failing to reach an agreement before the statutory deadline during this most recent negotiating period, the draft bill contains new requirements that the negotiating parties provide regular details about user fee discussions and publish meeting minutes within 30 days. Unlike the House version of the reauthorization, the bill does not propose to revise the FDA’s accelerated approval process or place additional requirements for the reporting of medical device shortages. HELP accepted public comments on the legislative draft through May 22. The programs must be reauthorized before the current user fee agreements expire on September 30.

WH Signals Renewal of PHE

The U.S. Department of Health and Human Services (HHS) will renew the COVID-19 public health emergency (PHE) declaration beyond the current expiration of July 16. The White House previously stated that it will provide a 60-day notice before terminating or allowing the PHE declaration to expire. In the absence of apublic announcement from the White House last week, the current PHE expires in less than 60 days. Therefore, another three-month extension of the PHE declaration, and the regulatory flexibilities that accompany it, through October are expected. The Biden administration continues to reiterate its calls for Congress to approve additional funding for pandemic response. A $10 billion coronavirus emergency funding package looks to be stalled until at least mid-June, being lower in priority than the Congressional response to the infant formula shortage and passage of military and humanitarian aid to Ukraine. A deal on the latest COVID-19 bill fell apart last month because of Republican opposition to the administration’s lifting of Title 42 immigration restrictions. Democrats are weighing the option of supplemental border security funding to evade a vote on Title 42 attached to the COVID-19 aid package. The House of Representatives is not scheduled to have any votes between now and June 6. The Biden administration has warned that supplies of key COVID-19 therapies, including the monoclonal antibody bebtelovimad, the antibody treatment Evusheld, and the antiviral Paxlovid are at risk of being exhausted by the fall.

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