Mark Up Scheduled in House Subcommittee
Recent hearings by Senate and House committees and a scheduled markup underscore Congress' continued commitment to eliminating barriers that are slowing the development of effective drugs, devices, and biologics so that patients can access these safe and effective therapies sooner. Polsinelli has learned that the House of Representative's Energy & Commerce Health subcommittee will vote on its reform legislation on May 14.
In an effort to expedite the process of bringing new therapies to patients, the Senate's Health, Education Labor & Pensions committee and the Energy & Commerce Health subcommittee held hearings last week on improving the process for medical research and discovery at the National Institutes of Health (NIH) and the regulatory approval process within the Food and Drug Administration (FDA).
Revised "21st Century Cures" Legislation Garners Support
The Energy & Commerce Health subcommittee unveiled an updated draft of its legislation, known as "21st Century Cures." A further revised draft of the bill will be unveiled early next week. The legislation would encourage the development of new and innovative therapies, which would allow all health care stakeholders – researchers, providers, innovators, companies, and patients – to benefit from an enhanced approval process and a robust research paradigm. Polsinelli is monitoring this situation closely and is prepared to assist clients as the committees move toward marking up legislation.
The current draft has bipartisan co-sponsors, including Rep. Diana DeGette (D-CO), and Energy and Commerce Committee Ranking Member Frank Pallone (D-NJ), who had not signed onto the earlier drafts. DeGette had pushed to include increased NIH funding and the new draft includes about $31 billion annually in FY 2016 through FY 2018. During an April 29 subcommittee hearing on the bill, DeGette said interested parties should submit their concerns to the committee as soon as possible. Polsinelli's Public Policy team is positioned and ready to facilitate a dialogue with the committee.
The new draft of the bill also includes a provision, which was not incorporated in earlier versions that would apply Medicare's technology add-on payments to new antimicrobial drugs. The policy originally was introduced as stand-alone legislation by Rep. Peter Roskam (R-IL) who is concerned that current Medicare reimbursement is not sufficient to support antimicrobial research.
The updated draft does not include a previous provision that addressed new drug market exclusivity. The earlier draft would have provided 15 years of exclusivity for newly approved "dormant therapy" drugs and a five-year extension for drugs that treat a life-threatening or serious condition. Also missing from the new draft is a provision adding two years of additional exclusivity for products that support increased patient adherence to approved treatment regimens compared to earlier approved formulations of the drug.
Congressional Comments Reinforce Commitment to Change
During the hearing on the bill, Energy & Commerce Health subcommittee Chairman Joe Pitts (R-PA) said that the committee is continuing to refine the bill and "absolutely committed to developing a modernized regulatory framework for these innovative and increasingly important tests and services." The subcommittee heard testimony from Dr. Kathy Hudson, deputy director for science, outreach, and policy, NIH; Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research, FDA; and Dr. Jeff Shuren, director of the Center for Devices and Radiological Health, FDA.
Pallone and several Democratic members of the subcommittee asked about the resources the FDA will need. Woodcock said that there is "a trade-off between putting out new guidances, implementing new authorities" and completing drug reviews. Shuren said "the more things that get piled on, the more we're set for failure."
Senate Hearing Focuses on Expediting Research Processes
In the Senate, the April 28 HELP committee hearing was the third hearing the committee has held on expediting the processes at the NIH and FDA to move research and discoveries into clinical trials and eventually to FDA-approved treatments. Sen. Lamar Alexander (R-TN), the committee chair, said that Congress wants to ensure that NIH has the resources necessary to support early-stage research, which is the foundation of medical breakthroughs, and that the FDA is prepared to review the new drugs and technologies so that they can reach patients as quickly and safely as possible. Sen. Patty Murray (D-WA), the ranking member of the committee, also commented that continued bipartisan support and investment is needed in biomedical innovation to encourage continued medical breakthroughs and innovations in the United States.
Similar to the House subcommittee, the HELP committee also heard testimony from Woodcock and Shuren. Woodcock said that the FDA is working to improve collaborative efforts with the industry to improve communication about planned clinical trials and data requirements. Woodcock also said that the FDA's efforts were hindered by unfunded mandates that divert the FDA's resources and make it difficult to reach performance standards.
Shuren testified that unnecessary regulatory burden can hinder patient access to new therapies, but that lax oversight can result in patient harm and can increase costs. He said that shifting some FDA approval requirements from pre-market to post-market collection can help improve access.
Polsinelli will continue to provide updates as these reform efforts progress.
