With a written response to a hearing that the U.S. House of Representatives’ Ways and Means Subcommittee on Health convened on May 10, 2023, to examine “Policies that Inhibit Innovation and Patient Access,” PMC has raised the profile of its positions on several issues that have emerged as top priorities for lawmakers and agency officials in recent years.
Writing from its perspective as a Washington-based education and advocacy organization devoted to the advancement of personalized medicine, the Coalition used its statement about the hearing to spotlight what lawmakers can do in the coming years to demonstrate their commitment to protecting the future of targeted prevention and treatment strategies that two-thirds of Americans say they want and need. The statement promises to help lawmakers refine and strengthen their positions on some of the most challenging questions facing the United States health care system today.
To preserve and accelerate the presently rapid pace of progress in personalized medicine, the statement outlines recommendations across several policy areas, as follows:
Drug Pricing Provisions in the Inflation Reduction Act
PMC’s statement recommends that lawmakers take every opportunity to prevent, monitor, and correct for unintended consequences that may arise from the new drug price negotiation program that was established with last year’s passage of the Inflation Reduction Act.
Recognizing that this program will significantly alter a public policy-based set of drug development incentives in the United States that has helped drive at least 322 personalized medicines to the market since 2008, the Coalition’s statement emphasizes the importance of ensuring that drug price negotiations under Medicare do not unintentionally disincentivize the continued development of new personalized medicines.
The U.S. Food and Drug Administration’s Accelerated Approval Program
PMC’s statement also recommends continued support for the U.S. Food and Drug Administration’s accelerated approval program, which is designed to allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need.
The Coalition points out that dozens of treatments approved under accelerated approval have been classified as personalized medicines. The statement contends that with the increasing identification of new molecular drug targets, Congress should protect this pathway to ensure that personalized medicines can be reviewed in a flexible and timely manner by FDA and to provide greater opportunities for patients to benefit from novel drug development.
A Policy Providing for Transitional Coverage of Emerging Technologies at the Centers for Medicare and Medicaid Services
Finally, PMC’s statement underscores the need for the Centers for Medicare and Medicaid Services to release a policy proposal to provide Transitional Coverage for Emerging Technologies (TCET). The statement contends that for personalized medicine to realize its full potential at a moment of rapid progress in science and medicine, patients would benefit from a TCET policy designed to facilitate timelier access to innovative medical technologies.
‘Closer to the Future’
In the concluding section of its statement, PMC notes that each of these steps would “bring us closer to a future in which every patient has access to and benefits from an individualized approach to health care.”
