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Biomedical innovation legislation may stall in 2016.
Is there any chance “Cures” legislation will pass in 2016? Probably not by summer, as election-year activities will prompt an early exit from Washington. Thus the only chance for action on legislation promoting biomedical innovation is in a “lame duck” session of Congress in November. Rep. Fred Upton (R-Mich), lead House sponsor of the 21st Century Cures legislation, will no longer head the Energy & Commerce Committee next year due to House rules, and he is pressing hard for a final “Cures” bill to cap his tenure as chairman.
Meanwhile, the legislators are moving forward a group of bills to address the opioid abuse epidemic. These largely aim to bolster treatment programs in states and local communities and are easier to enact in an election year.
For the broader medical innovation measure, Upton and his colleagues in the House have been waiting for the Senate to act on companion legislation, which has been moving slowly towards a vote by the full Senate. A main obstacle for all parties is the difficulty of finding ways to pay for the many new programs and initiatives in the proposed measures.
In addition, some legislators are looking to add provisions designed to control drug prices, such as proposals to speed up FDA review of certain new generic drugs and to encourage value-based pricing arrangements. At the same time, Congress may be compelled to act sooner than later by the need to reauthorize the state children’s health insurance program (SCHIP) and pressure to support the administration’s Cancer Moonshot. If there’s no action this year, though, these and many other measures will be back on the Congressional agenda in 2017 as part of must-pass legislation to reauthorize FDA user fee programs. Agreement on some FDA-related initiatives this year could avoid a massive reform bill later.
At FDA, leaders are concerned that Congress will enact a host of new programs and requirements for the agency without providing any extra money to meet these new obligations. This would force FDA to “divert its already limited resources from critical public health activities” such as the review of new medical products, warned FDA commissioner Robert Califf. And that’s “not good for patients or for industry,” he advised at the Food and Drug Law Institute annual meeting on May 5. “It is critical that Congress provide an adequate and stable source of funding for this legislation,” Califf stated. And the Cures bill needs to be “carefully crafted” to avoid posing “significant risks” for FDA and American patients.