21st Century Cures Set for a Midweek House Vote

With $372 million carved out for the National Institutes of Health innovation account in 2017, and about $114 million assigned to President Barack Obama’s Precision Medicine Initiative for the fiscal year 2018, the 21st Century Cures Act has a lot at stake for healthcare in the United States.

The most recent draft of the bill was released late last week, with updates that include provisions around mental health, substance abuse, and child and family services, which had been left out of the previous version. A blog post curating the bill, posted by the Petrie-Flom Center, Harvard Law, draws attention to some of the more controversial provisions, including the use of real-world evidence to speed up the drug approval process (section 3022). In the draft, the term real-world evidence is defined as “data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than randomized clinical trials.”

Critics of this policy believe this a threat to the traditional randomized clinical trial, which is a more cumbersome and substantial process. The authors flag this provision, citing the risks associated with clinical trials, such as what happened with an immunotherapy trial last week. On the bright side, section 3021 supports the use of novel clinical trial designs, such as adaptive trials, to improve the efficiency of the drug approval process.

Overall, the bill has been developed to significantly propel medical innovation, by directing funds to specific products, improving processes, and hiring the appropriate personnel. A significant portion of the bill also addresses prevention, treatment, and recovery programs for substance abuse and mental health disorders, and include $1 billion in state grants to fight opioid abuse.

We have constantly been hearing about the behind-the-scenes lobbying efforts to push specific aspects of the bill. According to Kaiser Health News (KHN), interest groups are projected to have spent up to half a billion dollars, just between 2015 and the second quarter of 2016, on lobbying efforts. Former House Representative Lee Hamilton told KHN, that in a bill this size and this important, a number of groups will be trying to get language into the bill that supports their interests.

Interests vary. On the one hand, the trade group Pharmaceutical Researchers and Manufacturers of America (PhRMA) has been a very vocal supporter of the bill; meanwhile, patient advocacy groups are concerned that hastening the drug and device approval process could endanger patient safety. Academic and medical schools, however, anticipate increased grant funding and have pledged full support to the Cures bill.

The 21st Century Cures Act will be presented for a vote before the House of Representatives on Wednesday.