Capitol Hill Update
The Senate will return this afternoon to kick off a busy week of legislative business, headlined by floor action on the Bipartisan Innovation Act conference committee. Starting tomorrow, senators will consider 28 “motions to instruct” (summary) — procedural votes that are nonbinding but can be politically tricky depending on the scope of the particular issue — prior to formally entering the conference negotiation with dozens of lawmakers in both chambers. Additionally, the Senate is slated to consider the nominations of Joshua Frost to be an Assistant Secretary of Treasury and Elizabeth de Leon Bhargava to be an Assistant Secretary of Housing and Urban Development (HUD). Meanwhile, House lawmakers have adjourned for a weeklong district work period and will return to Capitol Hill on Tuesday, May 10.
House Oversight Committee Discusses Role of McKinsey & Co.’s Alleged Role in Opioid Crisis
Last week, the House Committee on Oversight and Reform held ahearing (TRP summary) to examine the alleged role played by McKinsey & Company in the opioid crisis. In particular, the Committee reviewed its interim staff report entitled, “The Firm and the FDA: McKinsey & Company’s Conflicts of Interest at the Heart of the Opioid Crisis.” The report revealed that McKinsey consultants frequently worked on Food and Drug Administration (FDA) contracts while also working for opioid manufacturers such as Purdue Pharma. The report also alleged that McKinsey failed to disclose these conflicts of interest to the FDA. The report further presented evidence that McKinsey used its government consulting work to solicit more business from opioid manufacturers and tried to influence government officials to advance the interests of its private sector opioid clients.
During the hearing, Democrats largely focused on: (1) McKinsey’s alleged conflicts of interest in its work with the FDA and Purdue Pharma; and (2) the marketing and sales strategies that McKinsey provided to Purdue Pharma that fueled the opioid epidemic. Conversely, Republicans shifted focus from McKinsey and Purdue Pharma to examining the role of the trafficking of illicit drugs — primarily opioids and synthetic opioid substances — across the U.S.-Mexico border. In her opening remarks, Chair Carolyn Maloney (D-NY) introduced bipartisan legislation that would tighten requirements for contractors to disclose potential conflicts.
Senate HELP Examines User Fee Agreements with FDA Center Directors
On Tuesday, the Senate Committee on Health, Education, Labor and Pensions (HELP) held ahearing (TRP summary) to discuss reauthorization of the Medical Device User Fee Agreement (MDUFA), Prescription Drug User Fee Agreement (PDUFA), Biosimilar User Fee Agreement (BsUFA), and Generic Drug User Fee Agreement (GDUFA). This hearing was the second of two hearings (TRP summary) held by the committee aimed at reauthorizing these four user fee programs at the Food and Drug Administration (FDA).
Bipartisan support emerged for measures contained within BsUFA aimed at promoting patient access to generics and biosimilars, with senators emphasizing the need to promote competition. Members also examined ways to spur the development of drugs for rare diseases, including suggestions that the FDA partner with analogous agencies in other countries. Other notable discussion themes from the hearing included: (1) the need for increased diversity in clinical trials; (2) better access to treatments for substance use disorders (SUD); and (3) the relationship between the FDA and the Centers for Medicare and Medicaid Services (CMS) when choosing to approve and provide coverage of products through the accelerated approval pathway. Notably, Ranking Member Richard Burr (R-NC) expressed his opposition to the user fee package in the event that measures to improve FDA accountability are not incorporated into the agreements.
House Appropriations Subcommittee Addresses Various VA Health Programs
On Wednesday, the House Appropriations Subcommittee on Military Construction, Veterans Affairs, and Related Agencies held a hearing (TRP summary) to discuss the various Department of Veterans Affairs (VA) health programs related to women’s health, mental health, homelessness, and general veteran care. Throughout the hearing, leaders from the VA fielded questions from members of Congress to evaluate the implementation and effectiveness of its programs to effectively provide all veterans access to high quality care.
Members assessed the adequacy of the appropriations within the Biden administration’s fiscal year (FY) 2022 VA budget request to accurately inform their decisions for the proposed FY 2023 budget. While there was bipartisan support for the current budget’s funding levels for the VA’s programs, Democrats argued that Congress must provide increased funding in FY 2023 to shore up the VA’s health care workforce to provide better quality care, integrate behavioral health care into primary care services to reduce veteran suicides, and increase women-specific health care services for more equitable care.
House Ways and Means Deliberates FY 2023 Budget Request with HHS Secretary Becerra
On Thursday, the House Ways and Means Committee held a hearing (TRP summary) to discuss the Biden administration’s proposed fiscal year (FY) 2023 budget (TRP analysis) with Department of Health and Human Services (HHS) Secretary Xavier Becerra. The Secretary fielded questions related to the President’s budget, as well as other health policy related topics, including: (1) Medicare and Medicaid reform; (2) prescription drug pricing; (3) child care and maternal health; (4) health care workforce; and (5) pandemic flexibilities, among other items.
Throughout the hearing, Republican members addressed the delayed Medicare Trustees Report and the surprise billing law (part one and TRP analysis; part two and TRP analysis; part three and TRP analysis) implementation, while Democrats generally supported the budget request. Notably, bipartisan agreement arose surrounding the costs of prescription drugs, and Secretary Becerra called on Congress to pass legislation to allow Medicare to negotiate drug prices.
Senate Appropriations Subcommittee Questions FDA Commissioner Califf on FY 2023 Budget Request
On Thursday, the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration (FDA), and Related Agencies held a hearing (TRP summary) with FDA Commissioner Dr. Robert Califf to deliberate President Biden’s fiscal year (FY) 2023 budget request. During the hearing, Dr. Califf stressed the importance of data and technology modernization in most of his exchanges with lawmakers, especially in discussing food safety and supply chain concerns. While Republicans expressed some concerns about the price tag of the President’s budget request for the FDA, the discussion generally focused on anticipated FDA guidance and plans to improve upon the agency’s efforts to better fulfill its mission to regulate food safety, nicotine, and opioids.