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Jill Wechsler is BioPharm International's Washington Editor, firstname.lastname@example.org.
The 21st Century Cures Act took a giant step forward with a 344-77 approval in the House; the Senate debate is still ahead.
Despite opposition from consumer advocates that the bill would bring unsafe and untested drugs to the market-and from conservatives about excessive costs-leaders of the House Energy & Commerce (E&C) Committee orchestrated a 344-77 vote in favor of the long-debated 21st Century Cures Act. E&C chairman Fred Upton (R-Mich) retained Democratic support for the measure by boosting funds for the National Institutes of Health (NIH), a provision that drew a serious challenge from fiscal conservatives, but was upheld in the end. Democrats led by Rep. Diana DeGette (D-Col) helped sideline the naysayers.
The budget increase for NIH brought strong support from the biomedical research community and medical societies across the board. Leading up to the July 10 vote, Upton and his allies issued a barrage of statements from hundreds of patient and rare disease groups, universities, cancer centers, and drug and medical device companies cheering provisions in the bill designed to accelerate new biomedical discoveries and speed important treatments to patients. Former FDA commissioner Mark McClellan, now at the Brookings Institution, joined with cancer advocate Katie Couric and Friends of Cancer Research Chair Ellen Sigal in a Huffington Post editorial on how the bill will accelerate the pace of discovering new cancer treatments without compromising safety. More public-private scientific collaborations, genetic analysis, and use of electronic records and other systems to capture patient experiences will strengthen the evidence needed to develop and regulate medical products, they stated, in emphasizing the importance of this “unprecedented opportunity” to change the status quo.
At the same time, however, the White House issued a statement just before the House vote that echoed the safety alarmists. The administration raised concerns about provisions that extend exclusivity for drugs gaining added orphan-drug indications and that permit approval of new indications based on clinical evidence, rather than controlled trials.
The bill now goes to the Senate, where it will face intense review of its costs and consequences. Leaders of the Senate Health, Education, Labor and Pensions (HELP) Committee have stated that they will hold hearings on these key issues in the Fall and craft their own proposal. This raises questions about whether revisions to address safety issues will undermine the bi-partisan agreement achieved in the House, and whether Congress will be able to agree on a final bill before the end of the year.