Rep. Fred Upton (R-MI), pictured, is the sponsor of the 21st Century Cures Act.
The revamped 21st Century Cures Act no longer includes a provision that would have exempted drugmakers from disclosing continuing medical education payments to doctors.
The latest version of the bill, released Friday, would have allowed manufacturers to be exempt from reporting industry payments to physicians for textbooks, journal reprints, and for speaking at continuing medical education events. A spokesperson for Rep. Diana DeGette (D-CO), who has spearheaded the bill along with Rep. Fred Upton (R-MI), confirmed that the provision has been stripped out of the 21st Century Cures Act.
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A number of lawmakers in recent days criticized the provision, with Sen. Elizabeth Warren (D-MA) describing the exemption as covering up bribery in a speech on Monday. Sen. Chuck Grassley (R-IA) had said Monday that he plans “to object to unanimous consent to take up the 21st Century Cures Bill in the Senate” unless the reporting exemption is removed. Grassley co-authored the Physician Payments Sunshine Act. That legislation, passed as part of the Affordable Care Act in 2010, requires drugmakers and medical device makers to disclose payments they make to physicians to a public database.
The drug industry has fought to exempt the reporting requirements for CME for years. John Kamp, executive director for the Coalition for Healthcare Communication, expressed disappointment at the removal of a “reasonable provision that enables doctors to be fully informed about medicines.”
House lawmakers released what they call the “final” version of the bill last weekend. They are expected to vote on the legislation on Wednesday.
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The wide-sweeping bill includes other provisions that would impact marketers. It has a section that would require regulators to evaluate the usefulness of data collected outside of randomized clinical trials — information that is currently considered off label. The Cures Act calls for the Department of Health and Human Services to establish a regulatory framework that would be used to determine the usefulness of real-world evidence — or data obtained outside of randomized clinical trials.
The framework is meant to investigate whether off-label information could help support the approval of new indications and satisfy post-market study requirements. A plan for how the FDA would evaluate that information would need to be created within two years of the bill’s enactment.
Critics say allowing off-label communications to inform the FDA approval process creates a double standard of evidence. “The [real-world evidence] provision will create a double standard for the level of evidence needed to approve the first indication of a drug versus subsequent indications of a drug,” said Michael Carome, director of Public Citizen’s Health Research Group.
See also: Lawmakers advance 21st Century Cures draft; proposal would allow sharing of off-label economic data
Updating current off-label regulations has become a priority for drugmakers. Amarin and Pacira Pharmaceuticals both sued the FDA in 2015 over their rights to share truthful and unapproved information with healthcare stakeholders. The FDA held a public hearing in November to hear from drugmakers and others about the risks and benefits to allowing off-label communications.
The 21st Century Cures Act is one of the most lobbied healthcare bills in recent history, with 1,455 lobbyists representing 420 companies, universities, and other organizations looking to influence the bill’s contents, according to data from the Center for Responsive Politics, as cited in Kaiser Health News.
Andrew Powaleny, a spokesperson for pharmaceutical industry group, PhRMA, said the bill will “enhance the FDA’s ability to adapt to cutting edge technologies utilized by America’s biopharmaceutical companies to bring new medicines to patients.”