21st Century Cures Act Nears Passage with Little News Media Scrutiny

With the exception of STAT News, a few other mainstream media outlets, and some boosterish op-eds appearing in local papers, the news media haven’t said much about the 21st Century Cures Act over the past 6 months. It’s fair to say most Americans are in the dark about that far-reaching bill passed by the House of Representatives last summer and now winding its way through the Senate.

A Step Backward for FDA Standards

Recall that the Cures Act lowers already weak standards for FDA approval of medical devices, and would allow companies marketing “breakthrough” devices to submit evidence of safety and efficacy based on sources other than clinical trials, including case histories which could mean the experiences of individual patients.

They would not have to conduct time-consuming and expensive clinical trials, randomized or not. As I wrote last August they “could submit documentation that Joe Blow Patient’s health had improved by having some device implanted in his chest.” At the time Dr. Rita Redberg, a prominent cardiologist at the University of California, San Francisco, told us, “This will result in a lot of dangerous drugs and devices on the market with no evidence.” […]

Public Not on Board with Speedier Approvals

STAT’s contribution: A piece about the legislative wrangling over mandatory appropriations for the National Institutes of Health (NIH), which Democrats are trying to link to the bill’s other provisions; a discussion of a survey it conducted with the Harvard School of Public Health that found a majority of the public opposes regulatory changes that speed up the development and approval of new medical treatments; and a commentary by long-time pharma industry columnist Ed Silverman who concluded that coupling funds to speedier approvals “is a misguided notion that, unfortunately, is more likely to help companies than patients.” One Harvard expert he talked to called it the “19th Century Fraud Act.”[…]

Consumers and Physicians are Confused about “Breakthroughs”

[…] The bill defines breakthroughs as devices that offer “significant advantages over existing approved or cleared alternatives” or are in the “best interests of patients.” Dhruva argued that those requirements are vague and lack meaningful benchmarks and that “once a device is designated as a breakthrough, the legislation erodes that device’s standards.”[…]

The National Center for Health Research, a non-profit think tank that analyzes and explains the latest research-based information for patients and policymakers, strongly opposes the Senate’s breakthroughs bill as well as other provisions such as one that deregulates electronic health records and other electronic health technology. That provision would also prevent the FDA from collecting data about harms caused by the technology or from recalling defective software even though it may have life-threatening flaws. The Center has studied FDA-reported recalls of medical software and what they found is disturbing: more than 600 software devices and 1.4 million units have been recalled for presenting moderate or high risks to patients. The Senate’s version of the House bill weakening the approval process and allowing anecdotal evidence to substitute for clinical trials is more moderate. Still, says Diana Zuckerman, the Center’s president, her group is concerned with the Senate’s bill.  “It’s not nearly as broad, but it does lower standards,” she told me. “I didn’t think there was any way to humanly lower the standards (for device approval), but they have found a way.”

Today’s Lobbyist-led Provisions are Tomorrow’s “Poor Government Regulation”

The nitty-gritty of crafting legislation is something the press usually doesn’t give a hoot about. It’s boring, too much inside baseball, the language will change a zillion times, and changes are hard to trace unless you have a reliable guru to help. It’s an old press dilemma. The deck is stacked against journalists who want to track the lobbyists’ handiwork. But unless a bill like the Cures Act and its Senate counterpart get more scrutiny, it will be easy for drug and device manufacturers and other interests that will gain financially to sneak in provisions that benefit them and not the public.[…]

Read the full article here.