High-priority issues requiring immediate attention leave little time for Congress to consider drug access proposals that have limited bipartisan support.
Despite multiple proposals on Capitol Hill that target the high cost of prescription drugs, a long list of high-priority issues requiring immediate attention leaves little time to consider drug access proposals that have limited bipartisan support. Even the clamor for action to counter the nation’s deadly opioid epidemic is not expected to lead to further legislative action. And there’s little prospect of substantive changes in the Affordable Care Act (ACA) this year despite continuing pressure from the White House for Congress to “repeal and replace” Obamacare.
A first order of business for members of Congress returning to Washington after Labor Day is to raise the debt ceiling well before a mid-October deadline. Tax reform remains high on the legislative agenda for both the White House and Republican leaders, as is the need to continue funding the federal government before Oct. 1, 2017 to avoid a government shutdown.
In the healthcare arena, the top priority for legislators is to reauthorize the Children’s Health Insurance Program (CHIP), which will expire if not renewed by Sept. 30, 2017. Because of the tight timeframe, Congressional staffers are looking to enact a “clean” CHIP bill by mid-September, as they did to push through the FDA Reauthorization Act in early August. The CHIP bill may include an extension of funding for federally qualified health centers (FQHCs), but not any proposals to expand drug importing or permit Medicare drug price negotiations, according to senior health policy aides in the House and Senate health committees at a briefing sponsored by the Alliance for Health Policy on August 24.
To address opioid abuse and misuse, Congressional committees plan to examine how well state and federal agencies are utilizing recently increased funding for addiction treatment programs. There is some interest on Capitol Hill on proposals to enact an FDA plan to collect user fees for over-the-counter drug regulation, but that may move forward slowly in the wake of the fast action on FDARA. The House Energy & Commerce Committee will discuss the right-to-try legislation approved by the Senate, but House members have their own proposals for expanding access to experimental treatments for very ill patients, and it will take time to agree on a common approach. Staffers expect the “drug pricing conversation will continue,” but not lead to legislative action until there is broader agreement on policies likely to have a real impact.
The Senate Health, Education, Labor, and Pensions (HELP) Committee plans to hold four hearings this fall on strategies to stabilize the ACA exchanges, with the first two sessions on September 6 and 7 to hear from state insurance commissioners and leading governors on targeted reforms. Some “tweaks” in the current program are possible, but only in areas that have strong bi-partisan support.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.