21st Century Cures Act passage highlights need for improved comment period

The 21st Century Cures Act, approved by Congress in December 2016, authorized $6.3 billion in federal funding, mainly for the National Institutes of Health (NIH). It was supported in large part by pharmaceutical manufacturers.

The bill and key changes made during its drafting remain controversial and show the need for a more informed comment period for future health-care legislation, said an expert on health law at Washington University in St. Louis.

“One particularly noteworthy dimension of the 21st Century Cures Act was the way in which it originally moved through the House of Representatives,” said Rachel Sachs, associate professor of law.

Rachel Sachs

“The House took the unusual step of soliciting public input during the development of the bill, and we wanted to study that input and its impact on the bill that ultimately passed the House.”

Sachs and co-authors Thomas Hwang and Aaron Kesselheim, both of Brigham and Women’s Hospital and Harvard Medical School, tackled these issues in a recent paper titled “Public Participation in Drafting of the 21st Century Cures Act,” published in the Journal of Law, Medicine & Ethics.

“We found that this public input — about two-thirds of which came from patient organizations, professional societies and public health organizations — appeared to correlate with changes in statutory language moderating many of the more controversial provisions of the act,” Sachs said.

The drafting of this bill was not simple by any means, she said.

“From the time the first discussion draft was released in early 2015 to the act’s passage in late 2016, it was often unclear whether the legislative initiative would be moving forward at all. But this process of public input and compromise would be helpful going forward to legislators seeking to understand the real-world impact of their policy initiatives,” Sachs said.

Using publicly disclosed records of written comments on the bill, Sachs and her colleagues reviewed the key areas of lobbying activity and the compromises made in the final text.

They focused on legislative provisions relating to NIH management, incentives for medical product development and approval standards for new drugs and devices.

“By the end of the first comment period, the Committee received 118 comments,” the authors write in the paper. “Most respondents were patient organizations, professional societies and pharmaceutical and device companies. Overall, the majority of public comments were positive, although public health and consumer organizations were underrepresented in the number of submitted comments.”

As the legislative process continued, the draft bill underwent several changes relating to NIH funding, market exclusivity provisions and scrutiny of regulatory evidentiary standards.

“Understanding the key statutory provisions and how they have evolved could help patients, researchers and advocates make more informed comments on the bill and future health care legislation,” the authors write.

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