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. […]
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. […]
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