Republicans seize on reports critiquing FDA to push for agency reforms

Sheila Kaplan, STAT News

June 15, 2016

Has Congress’s watchdog agency just given Tennessee Senator Lamar Alexander the ammunition he needs to push a stalled biomedical reform through the Senate?

The Government Accountability Office on Wednesday issued two critical reports suggesting that the Food and Drug Administration isn’t properly planning how to keep pace with medical science.

One report notes that the FDA lacks goals, targets, and time frames for keeping up with scientific advances — and also fails to track the money it spends on these efforts. The other finds fault with the FDA’s strategic plan, which is supposed to speed approvals of drugs and devices, especially combination medical products, such as heart stents that also deliver blood thinners to prevent clots.

The reports land just as time is winding down for the Senate to pass its version of the 21st Century Cures Act, which the House has already overwhelmingly approved. The bill aims to get drugs and devices to market more quickly.

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Some Democrats say it weakens FDA standards on drug and device approval too much. Critics also want more funding for both the FDA and the National Institutes of Health. To try to move things along, Alexander chopped the legislation into a series of smaller bills, but funding remains a sticking point.

A few weeks ago, Alexander took to the floor to urge action. “There is no excuse whatever for us not to get a result this year. And it would be extraordinarily disappointing to millions of Americans if we did not,” he said.

It’s not clear whether the GAO’s concerns about the FDA would be addressed by the 21st Century Cures bill, or by the Senate’s package of biomedical bills.

Neither the HELP committee Democrats nor the FDA were available for immediate comment.

Diana Zuckerman, a critic of the bills and the president of the National Center for Health Research, said the FDA is already focused too much on speeding up drug and device approvals and is not paying enough attention to “doing its job to protect the health and safety of patients and consumers.”

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