Lawmakers advance 21st Century Cures draft; proposal would allow sharing of off-label economic data

FDA
FDA

House lawmakers introduced a new discussion draft on Wednesday, making dozens of proposed legislative changes to the drug development and delivery process.


The 199-page draft is part of 21st Century Cures, a broad legislative effort initiated by Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.).


It makes dozens of proposals, including boosting funding for the NIH, modernizing search capabilities on ClinicalTrials.gov, requiring the FDA to establish a framework to assess patient experience data in regulatory decision making and establishing a priority review program for certain breakthrough medical devices and technologies.


Most of the proposals relate to the research and development of new drugs and devices, but several provisions address how manufacturers market and promote their products.


The draft would allow drugmakers to share healthcare economic information with payers and formulary committees. Current laws prevent pharma companies from sharing that information because it is considered off-label.


PhRMA has advocated for changes to FDA regulations around product communications, arguing that current regulations are outdated.

 

"We share the committee's interest in modernizing the FDA's regulation of healthcare communication to ensure healthcare providers have access to scientifically accurate and up-to-date information in order to achieve the best possible outcomes for patients," PhRMA President and CEO John Castellani said in a statement. 

The draft would also exempt physicians from reporting requirements relating to some continuing medical education activities. The Centers for Medicare and Medicaid Services last year changed the rules for what CME payments have to be reported to the Open Payments database, which collects data about financial relationships between manufacturers and healthcare providers. A spokesman for the CME Coalition applauded the decision to “exclude independent CME-related payments from the Sunshine Act's reporting requirements.”


House lawmakers revealed the first discussion draft in January. Those proposals were pared down before the release of the new draft.


The House Energy & Commerce Committee plans to hold a hearing Thursday about the draft. Officials from the NIH and FDA are expected to testify.

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