June 11, 2015

21st Century Cures Act

The US House of Representatives is considering legislation - the 21st Century Cures Act (H.R. 6) - that, among other things, is intended to promote medical research at the National Institutes of Health, speed up drug and treatment approvals by the Food and Drug Administration (FDA), create new incentives for drug companies to study rare diseases, and put a greater focus on patient data to move toward "personalized medicine." The Energy and Commerce Committee unanimously approved the bill on May 21 and it is expected to be taken up by the full House. The Senate is beginning work on a similar bill.


For a two-page summary of the House bill, click here. For detailed background information about the bill, see this Energy and Commerce Committee webpage, which also has information about submitting comments to the committee (bottom of page).


Below are some topics addressed in the legislation:


Research on Drugs for Rare Pediatric Conditions. One of the bill's provisions would extend an existing program designed to encourage drug companies to develop drugs for rare pediatric conditions. Under current law, enacted in 2011, developers of such drugs can get vouchers entitling them to speedier approval of another product. These valuable vouchers can be sold to other pharmaceutical developers. Those who advocate for more research on drugs for rare pediatric conditions are divided on the merits of the voucher system, and the three-year extension it would gain in the 21st Century Cures Act. Some believe that the voucher program may lead to approval of drugs that are not adequately tested. Others believe that the voucher program should be extended, and for longer than three years, so that its impact can be better evaluated. See this article from Kaiser Health News.


Drug and Device Testing in General. As noted above, one objective of the 21st Century Cures Act is to speed up the FDA's drug and device approval process. One of the ways it would do so is by altering some of the testing methods and standards currently required by the agency for deciding whether to approve a drug or device. Two Harvard physicians have expressed concern about these changes in a recent "Perspectives" piece published in the June 3 New England Journal of Medicine.