The updated 21st Century Cures bill may revise some financial disclosure requirements designed to prevent federally funded scientists from cozying up to drug and device companies.
The House is expected to vote Nov. 30 on a newly revised Cures bill, which lawmakers released late Nov. 25 as an amendment to the tsunami bill (H.R. 34). If enacted, the 21st Century Cures bill would culminate a three-year effort led by House Energy and Commerce Chairman Fred Upton (R-Mich.) and Rep. Diana DeGette (D-Colo.) to spur new medical treatments.
Industry groups and research advocates generally hailed the new bill as a life-saving measure that would provide billions of dollars in new funding for medical research and seeks to transform an enterprise in which developing a single drug costs more than $1 billion, takes a decade to complete and the vast majority of investigational products fail in clinical trials.
But Public Citizen maintains some of the provisions remain problematic, and Sen. Charles Grassley (R-Iowa) said he opposed some of efforts to pull back on reporting requirements of the Open Payments law he authored.
Changes in Pay-Fors
The new Cures bill maintains much of the same language from the version the House passed in 2015 (H.R. 6), and the reintroduction largely centers around changes in how to pay for the bill and how much funding to provide to the National Institutes of Health and the Food and Drug Administration ( see related story ).
“The base Cures bill itself looks pretty tame and is pretty much the same,” Bloomberg Intelligence senior health-care analyst Brian Rye told Bloomberg BNA Nov. 28. Rye noted one of the revised pay-fors is a win for the brand-name drug industry. The 2015 version of the bill excludes authorized generics when calculating the average price for Medicaid rebates.
“If you exclude the generic price from the average, that raises the rebates that pharma has to pay to Medicaid,” Rye told Bloomberg BNA Nov. 28.
But the latest Cures legislation has dropped some measures—including one on privacy–and added some human subject research measures that weren’t in the July 2015 version.
“It’s not just about the money, Yes we care deeply about the money and the money is integral,” Ellen V. Sigal, founder of Friends of Cancer Research, told Bloomberg BNA Nov. 28. “But there are mechanisms that go beyond the money that will really make for much more robust scientific infrastructure that will be working for patients and that’s what we care about.”
Conflict of Interest
Heather H. Pierce, senior director of science policy and regulatory counsel for scientific affairs of the Association of American Medical Colleges, said many of the new provisions fold in recommendations from a September 2015 National Academies report on how to improve the regulation of research in the U.S. or from the Senate companion effort to Cures led by Sens. Lamar Alexander (R-Tenn.) and Patty Murray (D-Wash.).
“Most everything in here we’ve seen somewhere,” Pierce told Bloomberg BNA Nov. 28, including the new conflict-of-interest language that comes directly from the National Academies report.
Part of a section on reducing administrative burden (Section 26), the conflict-of-interest provisions would require the Department of Health and Human Services to lead a review of financial conflicts of interest. Pierce said it’s an effort to reconcile various government financial relationship reporting requirements, which currently vary among the different funding agencies.
If enacted, the new conflict-of-interest measures would come about five years after the NIH went through a major overhaul of its own financial reporting requirements—the first such effort in 16 years. That policy both cut the NIH’s reporting threshold in half and increased the reporting requirements for scientists.
Another new provision in the new Cures bill, Section 4009, would exempt “certain transfers of value from reporting requirements that health care providers have noted have a chilling effect on their engagement in important continuing medical education activities.” Grassley said he plans to oppose the bill once it comes to the Senate unless lawmakers remove this provision because it would water down industry reporting requirements in his Sunshine law.
“We shouldn’t create a loophole that would let drug and medical device companies mask their payments to doctors under a payment category that’s too broad and could gut the spirit and the letter of the Sunshine Act,” Grassley said in a Nov. 28 statement.
Drug Exclusivity Changes
The bill also makes changes to some of the drug exclusivity language. Michael Carome, director of Public Citizen’s Health Research Group, pointed to a separate exclusivity provision of the 2015 bill that would have extended exclusivity periods for a drug approved for a new indication for a rare disease or condition (Section 2151 of H.R 6).
Carome told Bloomberg BNA he supported the deletion of this measure in the 2016 version because that language “would have increased drug prices and costs to taxpayers by as much as $12 billion over 10 years by extending monopoly protections for brand-name blockbuster drugs that receive additional approval to treat an orphan diseases.”
Potentially Harmful Provisions
While Carome acknowledged the bill has some improvements, Public Citizen continues to oppose it. The group called on Congress not to rush the bill through, issuing a statement of potentially harmful provisions.
One of those provisions, Section 3022, is the move to incorporate real-world evidence–data gathered from clinical settings instead of a randomized, controlled trial–into the FDA’s regulatory decisions. “This will weaken the standards for FDA review and approval of supplemental new drug applications (sNDAs) and lower the bar for the type of evidence needed to meet post-approval requirements,” the Public Citizen statement said.
But Sigal of Friends said the use of real-world evidence is incredibly important, particularly to advance treatments on rare diseases.
“It doesn’t mandate that FDA use it,” she said about the Cures language on real-world evidence. “It just gives them the ability to make the scientific decisions based on the strength of the evidence.”
Evaluating how well a new drug works along with its risks and benefits remains the gold standard for determining whether to approve it, she said. “We’re not supporting anything that doesn’t have rigorous scientific data and doesn’t have efficacy,” she said.
Privacy Protections
Kirk J. Nahra, a health privacy lawyer with Wiley Rein LLP, tweeted Nov. 28, “The worst #HIPAA language from the House version of 21st Century Cures is gone–at least for now.” He was referring to a provision in the 2015 bill that he said would have allowed FDA-regulated companies to buy protected health information, which currently isn’t allowed under the Health Insurance Portability and Accountability Act.
“When you’re writing the HIPAA rules, one of the things they’re worried about is drug companies getting data to use for marketing purposes. And drug companies aren’t covered by the HIPAA rules because they’re not covered entities. And this provision would have let them buy PHI from anybody,” Nahra told Bloomberg BNA. “it would have basically been a loophole removing all of the HIPAA protections for PHI.”
Other new provisions would:
- establish a research policy board, an ongoing, White House-level body that would evaluate U.S. research regulations;
- support the Precision Medicine Initiative;
- allow the secretary of HHS to exempt individual biomedical research data from being disclosed if the data are identifiable, or could be used to identify a research subject; and
- broaden an existing Certificates Confidentiality program that protects researchers from being compelled to disclose their research data if subpoenaed.
