Major FDA Reform Unlikely in Closely Divided Congress

While it may take weeks to know the final tally, neither Republicans nor Democrats are expected to have more than a slim majority in the House or Senate, which reduces the likelihood of highly partisan legislation in the months ahead. The economy and inflation were main concerns driving voters to the polls, but they did not generate the predicted ‘Red Wave’ to challenge Biden administration policies. At the same time, access to abortion was a prime issue, with voters supporting abortion rights ballot measures in five states. Even conservative voters opposed major reductions in health care, as seen in the vote in South Dakota to expand Medicaid coverage for low-income adults.

The situation makes it unlikely that Congress will tackle significant legislation during its lame duck session after Thanksgiving. Current members face a Dec. 16, 2022 deadline to approve an omnibus spending bill authorizing the federal government budget for 2023 to avoid a government shutdown. FDA would like the legislators to approve some of the measures dropped from the “slim” user fee reauthorization package approved in late September, but the calendar leaves little time for much debate. There’s a chance for approval of more targeted bills to revise FDA’s accelerated approval process, advance clinical trial diversity, clarify FDA inspection authority, and address cybersecurity in medical devices. But more complex measures to overhaul FDA regulation of in vitro diagnostics, cosmetics, and dietary supplements are likely to remain on hold until the new Congress convenes in January.

In the House, a shift to Republican control is most likely, setting the stage for GOP-led committees that will hold hearings and issue reports challenging a range of health care issues. FDA officials are likely to be called to Capitol Hill more often to explain actions related to the shortage in infant formula, difficulties in reducing deaths from opioids, its proposal to ban menthol cigarettes, and modified rules for accessing health care through video conferencing.

The Senate Health, Education, Labor and Pensions (HELP) Committee is expected to have new leadership even if Democrats retain control. Chair Patty Murray of Washington may move to lead the powerful Senate Appropriations Committee, which leaves Bernie Sanders of Vermont as next in seniority. And with ranking Republican Richard Burr (R-N.C.) retiring, Sen. Rand Paul (R-Ky) is in line to head the panel. Sen. Paul already is taking about committee investigations into the Biden administration’s inadequate response to the COVID-19 pandemic, with Anthony Fauci a prime target.

Republican promises to lower taxes and reduce inflation by slimming down federal spending raise uncertainties about support for future pandemic planning, replenishing national stockpiles of drugs and vaccines, expanding research at the National Institutes of Health and strengthening state Medicaid programs. A main target for GOP leaders is the Inflation Reduction Act (IRA), a prime initiative for the Biden Administration that featured a provision reducing consumer outlays for prescription drugs. Although Republicans criticize many aspects of the legislation, they are unlikely to have the votes to kill drug price negotiation authority for Medicare. At the same time, Republican leadership makes further drug pricing legislation unlikely, including proposals to curb pharmaceutical launch prices.

At the same time, Republican leaders are expected to press for changes in FDA policies to make it difficult for women to access approved abortions pills and to gain access to over-the-counter contraception. A main issue is slated to be FDA’s authorization of telemedicine visits for prescribing abortion pills, instead of requiring women to visit the doctor’s office. It also remains to be seen to what extent abortion foes question the right of pregnant women to access approved therapies for cancer and other lethal conditions that also could jeopardize the health of a fetus.

About the author

Jill Wechsler is Washington editor for Pharmaceutical Technology.