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Monthly Legislative Newsletter: May 2022
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State of Infrastructure and Reconciliation Negotiations

The past month saw few developments on the revival of a reconciliation bill as the Senate focused their attention on President Biden's Fiscal Year 2023 budget request and Senator Joe Manchin (D-WV) held discussions on a potential bipartisan energy package. While a health focused partisan reconciliation bill, the most likely vehicle for any significant drug pricing reform, remains possible, Senator Manchin’s convening of a bipartisan group for an energy package further pushes the effort down the legislative road. With Congress’ time taken up by China competitiveness legislation, a bipartisan energy package, and other must-pass efforts, the likelihood of a reconciliation package becomes increasingly smaller. Should negotiations not pick up before the Memorial Day recess, it is unlikely that a reconciliation package can be ushered through Congress before the September 30 deadline.

House Republicans Release New Health Platform

On May 2, 2022, House Republicans released a new health policy platform. The platform is an effort to lower out-of-pocket spending and provide greater access to new medicines and cures. To do this, Republicans will focus on removing government interference and bureaucrats from the American healthcare system. Additionally, Republicans are promoting American-made medicines so that patients and cures will no longer be “held hostage by supply chain disruptions or foreign government restrictions.”

View the 1-pager HERE.

Appropriations Update

The fiscal year 2023 appropriations process is currently in full swing with House and Senate Appropriations Committees holding hearings on President Biden’s fiscal year 2023 proposed budget. If history is any indicator, the House Appropriations Committee will release their own versions of appropriations legislation this summer with hearings, markups, and ultimate passage to follow. The Senate, on the other hand, tends to move rather slowly when compared to the House. In fiscal year 2022, the Senate only released draft legislation and did not go through the traditional legislative process.

Democrats in Congress are likely going to push for a deal to be reached between the House and the Senate before the midterm elections, as they would like to score a legislative victory while also showing the American people that they can effectively operate the government. However, with a 50-50 Senate, Democrats will need at least 10 Republicans to join them in funding the government, something that is increasingly unlikely the closer we get to the midterms. As time passes without significant movement from the Senate, it is more and more likely that a short-term continuing resolution will be needed in order to keep the government funded and operating.

FDA User Fee Reauthorization Package

On May 4, 2022, the House Energy and Commerce Committee released their bipartisan FDA User Fee Reauthorization Package. The package, unveiled by Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ), Ranking Member Cathy McMorris Rodgers (R-WA), Health Subcommittee Chairwoman Anna G. Eshoo (D-CA), and Health Subcommittee Ranking Member Brett Guthrie (R-KY), reauthorizes the Prescription Drug User Fee Act (PDUFA), the Generic Drug User Fee Act (GDUFA), the Biosimilar User Fee Act (BsUFA), and the Medical Device User Fee Act (MDUFA). The legislative package includes provisions that will:

  • Make improvements to FDA’s review for safety and efficacy of medical products, including cell and gene therapies, drugs for rare diseases, and novel medical devices;
  • Strengthen program integrity for the Accelerated Approval pathway and preserve patient access to approved treatments by ensuring that drugs show clinical benefit through post-approval studies in a timely manner and streamline the process for withdrawing approvals for drugs that fail to show a clinical benefit;
  • Ensure clinical trials are representative of diverse populations by requiring drug and medical device manufacturers to submit clinical trial diversity action plans to FDA early in their development process;
  • Bring down drug costs by making it easier for generic competition to enter the market; and
  • Provide FDA tools to ensure the agency can conduct thorough safety inspections efficiently.

As of now, the Senate Health, Education, Labor, and Pensions Committee has yet to release their version of the reauthorization. However, the release of the House package is significant as it starts the process towards reauthorization, which currently expires on September 30, 2022.

View legislative text HERE.

View section-by-section HERE.