House Releases Cures 2.0

On Wednesday, leadership from the House Energy and Commerce (E&C) Committee released the highly anticipated second discussion draft of the 21st Century Cures Act. In contrast to the first discussion draft released in January, this version received the support of not only Chairman Fred Upton (R-MI), but also Rep. Diana DeGette (D-CO), Health Committee Chairman Joe Pitts (R-PA), Ranking Member Frank Pallone (D-NJ), and Health Committee Ranking Member Gene Green (D-TX). The 200 page document is a greatly altered version of the first draft which was nearly 400 pages long. The more streamlined bill now organizes legislative language into three sections on discovery, development, and delivery which is a clear nod to the original intent of the 21st Century Cures Initiative – to accelerate “the cycle of discovery, development, and delivery of promising new treatments and cures.”

Over 25 provisions have been removed from the original, most notably an assortment of provisions with authorizing language for additional funding on programs ranging from the BRAIN Initiative to the National Institutes of Health’s (NIH) Common Fund. They have been exchanged for a much bigger win for those advocating for increased biomedical research funding. The bill now would authorize $31.8 billion to be appropriated in fiscal year 2016, $33.3 billion for fiscal year 2017, and $34.8 billion for fiscal year 2018. Note, NIH was appropriated around $30 billion for fiscal year 2015, and it would remain at the discretion of the Appropriations Committees to make these authorized amounts available. The bill would also establish a NIH Innovation Fund which would provide another $2 billion per year over the next five years to support emerging scientists, precision medicine, and other priority areas yet to be determined.

The bill still asks the U.S. Food and Drug Administration (FDA) to take on a considerable amount of new work including developing a tailored pathway for the review of antibacterial and antifungal drugs, awarding grants for research on continuous drug manufacturing, and writing and finalizing at least 10 guidances within the next several years. Many have expressed concern that FDA will not be offered the additional resources necessary to successfully implement these new programs. The new draft fills in a key provision on FDA hiring practices to help ensure that FDA has the staff necessary to keep pace with the workload. Because FDA has permanent authorization, the bill does not authorize an increase in FDA funding. Still, Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research at FDA, expressed worry this week that without additional resources there would be an increase in the time it takes to review medical products, contrary to goals of the Cures Act.

Several industry incentive provisions have been cut as well. These provisions would have offered protection periods for developing treatments for patients where there are unmet medical needs, developing treatments for patients with rare diseases, repurposing old drugs, and for manufacturing generic drugs in the United States. Instead, E&C Committee members have included a placeholder for future legislative language on what Rep. Pallone hopes to be a “much more tailored approach to solving a targeted problem.”

Several placeholders that existed in the first draft have now been filled including a section that would require FDA to issue, and update, guidance documents intended to help advance the clinical development of genetically targeted treatments to complement the work of NIH on the President Obama’s Precisions Medicine Initiative. Several other sections remain empty. As an example, the Committee has yet to share legislative language on interoperability which is sure to greatly impact physicians and electronic health record vendors. Rep. Michael Burgess (R-TX) promised during a hearing on the 21st Century Cures legislation Thursday that he has great minds working on the issue and that interoperability remains a top priority. Of note, a placeholder for the reform of diagnostics regulation has been removed entirely. Chairman Pitts immediately acknowledged the absence of a provision on the issue at Thursday’s hearing, but ensured that Committee members remain committed to creating a modernized regulatory framework and that they will be working with stakeholders in the coming weeks to advance legislation.

Many share Rep. DeGette’s sentiment that there is still “a great deal more work to do,” while CRD works to help our clients respond to the many provisions as well as continue to influence the ultimate legislative package. While there are details to work out and sections yet to be completed, Chairman Pitts relayed that the bill is representative of the significant bipartisan collaborative effort that has been in the works for over a year now. The Committee hopes to markup the bill soon.

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