The House Committee on Energy and Commerce’s Health Subcommittee is working on nine health-care related bills this morning (details and list here) and early drafts have included provisions that would make medical devices and prescription drugs more expensive and/or much harder to get. (In question are the Drug Safety/Risk Evaluation and Mitigation Strategy (REMS), and Clinical Trials discussion drafts.)
At issue is federal pre-emption of state regulations governing the manufacturing, labeling and quality control of devices and drugs. Back in 1976, Congress gave the FDA exclusive authority to regulate the safety and effectiveness of medical devices — from the machinery that tests you to the devices like pumps, stents and pacemakers that doctors put in you. Specifically, Congress pre-empts state requirements that are “different from or in addition to” the FDA’s standards. And although the law is less clear in this area, courts have generally understood that the federal pre-emption applies to drugs, as well.
Congress recognized that R&D would disappear if drug and equipment manufacturers faced an impenetrable world of 50 state regulatory regimes and, even worse, 50 different court systems followed by 50,000 trial attorneys hungry for a big payoff. Given the growing complexity of medical technology – the combination of devices with drugs and biological agents, the prevalence of software and sophisticated computer technology in so many innovations, and the promising field of nanotechnology – the need for the pre-emption protection is more important than ever.
At least until this morning, the legislation included provisions that would nullify pre-emption provision. The result? The most fundamental change in prescription drug and medical device law in the past 30 years. And so far, no public hearing!
Word now comes that the provisions may be gone by 10 a.m. when the committee convenes, but you know how provisions come and go. If this radical change is to be considered, then it deserves the disinfecting light of public scrutiny as well as a public hearing. The public’s health demands it.
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