The Senate's version of the House-approved 21st Century Cures Act (HR 6) is attracting stakeholder attention -- and not just for its different approach. Patient safety experts say the bill has promise, but more changes are needed as the Senate and House look to create a final, joint proposal.
The House passed the 350-plus-page bill aimed at bolstering medical innovation 344-77 in July. The legislation targets two main areas: regulation for drugs and medical devices and federal funding for biomedical research.
At the time it passed in the House, the Cures Act enjoyed overwhelming support from lawmakers, American Health Line reported last year. However, stakeholders have raised concerns about the bill's practical effects. Namely, parts of the bill pertaining to drug and device regulation drew criticism from patient safety advocates. The bill's fiscal sustainability is also uncertain.
Rather than consider an identical counterpart to the Cures Act, the Senate Health, Education, Labor and Pensions Committee took a piecemeal approach, advancing 19 bills over the last few months that serve as companion legislation to the House's measure. Like the Cures Act, the Senate committee proposals address medical devices and drug regulations.
Cross-examining the patient safety proposals
The Senate HELP Committee's decision to consider several smaller bills helped to address some patient safety advocates' concerns regarding the Cures Act.
Diana Zuckerman, president of the National Center for Health Research, in an interview with American Health Line said, "By examining each aspect of the Cures Act piece by piece, the Senate rejected several of the worst sections of the so-called Cures Act."
For example, she noted that the HELP bills do not include a provision for third-party review of medical devices. Zuckerman explained, "The third-party provision is especially dangerous because it would apply to high-risk devices that have been modified by the manufacturer." She continued, "Instead of the company notifying the FDA of the change and proving that the modified device is still safe and effective, the company could hire a 'third party' to review the device companies' written policies on quality control ... and determine that the company's policies are adequate and therefore the company can be trusted to make revisions to their high-risk devices."
However, Zuckerman noted that "none of the Senate bills do much to reassure patients that FDA approval means medical products are truly proven safe and effective, as studied on sufficient numbers of patients, including women, men, people of color, and patients over 65." She cited Sen. Patty Murray's (D-Wash.) bill (S 2503) on reusable devices as an exception.
Linda Radach, a charter member of Washington Advocates for Patient Safety who works with Consumers Union Safe Patient Project and the National Center for Health Research, told American Health Line, "[L]egislation from both the House and the Senate has a strong common theme which places industry above what is best for patients."
Zuckerman also expressed concerns about several of the proposals HELP has advanced. One Senate bill, the PATH Act (S 185), would require FDA to create a program for approving certain antibiotics for limited populations. Zuckerman noted that the PATH Act "is much better than the [Cures Act] version, but it does not protect against the overuse of antibiotics," which is a major contributor to antibiotic resistance.
Some experts -- including Allan Coukell, senior director for Health Programs at Pew Charitable Trusts -- have written favorably about the PATH Act. In a Health Affairs blog post, Coukell wrote that the bill would allow FDA to "approve antibiotics for limited populations of patients with serious and life-threatening bacterial infections that are resistant to current treatments," such as those to treat superbugs like MCR-1. According to Coukell, such proposals -- including the ADAPT Act included in the House Cures Act -- have "broad, bipartisan and bicameral support."
When it comes to funding, HELP has not yet advanced a proposal.
HELP Chair Lamar Alexander (R-Tenn.) in a statement said he hopes to present the companion legislation package to Senate Majority Leader Mitch McConnell (R-Ky.), along with a plan that would provide an influx of one-time funding for targeted NIH targeted efforts, such as President Obama's Precision Medicine Initiative and the National Cancer Moonshot Initiative.
Democratic HELP senators in the meantime have proposed legislation (S 2624) that would "provide funding for select initiatives at ... top research institutions, NIH, and FDA, in years when congressional appropriations to the agencies increase," according to a fact sheet.
As passed by the House, the Cures Act would create a temporary "innovation fund" to provide NIH with $8.75 billion over five years. In addition, the bill would give FDA $550 million over five years.
Stuart Schweitzer, a professor of health policy and management at the UCLA Fielding School of Public Health, told American Health Line that any funding plan for NIH "needs to be long-term, rather than annual, because an increasingly large number of projects are medium- or long-term in nature." He added that uncertainty about funding means NIH "is in the difficult situation of telling a researcher 'We can support you for one or maybe two years, but we can't guarantee continuation of support beyond that -- that's up to Congress.'"
Overall, lawmakers appear optimistic about the future of a final Cures package that will bolster innovation while protecting patient safety. As Alexander said in a recent statement, "We continue to work to find an amount that the House will agree to, the Senate will pass and the president will sign."
-- by Rachel Schulze, senior staff writer