Congress Leaves Town with Major Drug-Related Bills on Hold

The legislators departed Washington, D.C. in late July for a six-week summer recess without passing a host of critical budget bills, including key measures involving health care and drug regulation. At the top of the legislative to-do list are multiple appropriation bills to continue funding the federal government past Sept. 30, 2023. Another important measure on hold would reauthorize programs to prepare the nation for the next pandemic. And policies to rein in pharmacy benefit managers (PBMs) gained approval from some committees, but not a final vote.

Demands to radically cut spending and to further limit access to abortion erected major roadblocks to agreement on important funding bills, as conservatives in the House demanded spending cuts unacceptable to Democrats and moderate Republicans. Only the Department of Veterans Affairs saw its budget approved, enabling members of Congress to claim support for military veterans when engaging with constituents back home.

While the Senate passed most fiscal 2024 spending measures, very partisan proposal in the House blocked any agreement on final measures. Funding for the Department of Defense was stymied by Republican opposition to a Biden administration policy to fund travel of armed forces members to obtain abortion services. House Republicans alienated Democrats with cuts in multiple agencies in the Department of Health and Human Services (HHS), including the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) and proposed to eliminate the Agency for Healthcare Research and Quality (AHRQ), a perennial target of conservatives.

Similarly, the House measure to fund the Department of Agriculture, including FDA programs, made significant cuts in food program such as foreign food aid and support for US food exports, outraging both Republicans and Democrats from rural states. Not only was FDA’s overall budget slashed, but the bill sought to ban mail order delivery of the abortion pill mifepristone, a proposal that drew a veto threat from the Biden administration. The Agriculture/FDA funding bill in the Senate provides a slight 1% budget increase for FDA, which means less severe but still significant program reductions.

Pandemic preparedness

House and Senate committees made some progress on legislation to support national preparedness and response to future pandemics, which has to be reauthorized before it expires Sept. 30, 2023. But that tight timeframe for passing the Pandemic All Hazards and Preparedness Act (PAHPA) is encouraging lawmakers to include various pet programs and policies in the measure. The Senate Health, Education, Labor and Pensions (HELP) committee approved PAHPA on July 20, 2023, readying the measure for a vote by the full Senate in September. HELP committee chairman Bernie Sanders added a number of provisions, including one requiring drug manufacturers to notify FDA in advance of product shortages and other shortage-related provisions. While the legislators generally back continued support for preparedness, House Republicans moved to slash funding for the program, setting up a partisan battle over the program’s future.

Reining in PBMs

Also pending is legislation to boost transparency and revise fees from insurers to pharmacy benefit managers (PBMs). These drug plan middlemen have been under attack from manufacturers and policy makers for failing to pass on savings to consumers and limiting patient access to certain medicines, and both the House and Senate held hearings this past year to consider reforms. Continued Federal Trade Commission investigation of PBM practices has set the stage for legislative reform.

Despite this support for change, the policy reforms in current bills appear relatively tame. The Senate Finance Committee recently approved a legislative package aimed at boosting transparency of PBM practices affecting Medicare Part D plans. And the House Ways & Means Committee similarly agreed to give patients and employers more information to stimulate competition in the field. House Republicans approved a bill that Democrats opposed as too weak, raising the likelihood of differing bills from the House and Senate in the fall which may be hard to reconcile.

With the August recess extending through mid-September, Congress will have only a few days to approve 12 appropriations bills and other expiring measures before the September 30 deadline. Unless the feuding parties reach some agreement, that could mean a federal government shutdown in October and added difficulties in maintaining the nation’s health care system, along with a viable drug approval and regulatory program.

About the author

Jill Wechsler is Washinton reporter for BioPharm International®.