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.


House Passes UFA Legislation

The House of Representatives passed H.R. 7667 to reauthorize medical product user fees at the Food and Drug Administration (FDA) through fiscal year (FY) 2027 last week. The bill was passed under suspension of the rules in a 392-28 vote. The Congressional Budget Office’s estimated budgetary effects of the Food and Drug Amendments of 2022 was released several days before House passage and can be found here. Among other things, the package includes provisions to revamp the agency’s accelerated approval process and increase clinical trial diversity.

The Senate continues to work on its own version of the reauthorization package. The two proposals differ in several respects, such as the inclusion of clinical trial diversity measures and a pediatric cancer research provision (based on H.R. 6972, the Give Kids a Chance Act) in the House bill. Unlike the House version, the Senate’s bill includes language to overhaul the cosmetic, dietary supplement, and laboratory-developed test (LDT) regulatory framework. Leadership have not stated how they will reconcile the differences between the two bills. The Health, Education, Labor, and Pensions Committee is scheduled to markup the Senate’s bipartisan bill on June 14. Sen. Bernie Sanders (I-Vt.) has already told reporters that he plans to offer an amendment to allow for the importation of prescription drugs during the markup. Lawmakers aim to send user fee legislation to the President’s desk before the congressional August recess. The current user fee authorization will expire at the end of the fiscal year on September 30.

House to Consider ARPA-H Next Week

The House of Representatives will consider legislation (H.R. 5585) to establish the Advanced Research Projects Agency for Health (ARPA-H) the week of June 20, according to Majority Leader Steny Hoyer (D-Md.). The chamber will also consider the package advanced by the House Energy and Commerce Committee to address the opioid abuse and mental health crisis, as well as legislation from the Education and Labor Committee on mental health, addiction, and suicide on college campuses. Finally, the House will vote on the STRONG Veterans Act (H.R. 6411), which aims to combat veteran suicide.

Senate Reaches Bipartisan Agreement on Gun Violence Framework

Senate negotiators, led by Sens. Chris Murphy (D-Conn.) and John Cornyn (R-Texas), have reached a bipartisan deal on a narrow set of gun safety measures with enough support to overcome a filibuster in the evenly-divided chamber. The package would include funding for mental health resources and school security as well as grants to states to enact red flag laws. It would also expand the nation’s background check system to include juvenile records for any prospective gun buyer under the age of 21. The lawmakers must now translate these measures into legislative text. The plan currently has the endorsement of 10 Republicans and 10 Democrats. Majority Leader Chuck Schumer (D-N.Y.) had pledged to put the legislation up for a vote once the agreement is finalized.

The House of Representatives passed its own package of gun control measures in a 223-204 vote last week. Only five Republicans voted in support of the legislation, which would raise the minimum age to purchase semiautomatic rifles from 18 to 21, restrict the sale of large-capacity ammunition magazines, and set federal standards for the safe storage of firearms. The House also passed a bill to allow federal courts to temporarily confiscate guns from individuals deemed by a judge to pose a threat to themselves or others. The red flag proposal passed 224-202, with five Republicans voting in favor of the bill.

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