Leave drug safety to the FDA, not the assistant secretary of defense

Leave drug safety to the FDA, not the assistant secretary of defense
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It is no small irony that, on the very weekend that the U.S. was celebrating the contributions of our veterans to our collective security, the U.S. Congress was putting the finishing touches on legislation that has the potential to place current service members at great risk.

The conference report for the National Defense Authorization Act (NDAA) for fiscal 2018, which was adopted last week, contains a provision that allows the “Assistant Secretary of Defense for Health Affairs to approve certain medical products for use by combat medics to improve chances of survival on the battlefield.”

In short, Food and Drug Administration (FDA) approval would not be needed for drugs and medical devices that are given to U.S. troops under certain conditions. That turns on its head what has been a bedrock principle of U.S. public health for over a century: that oversight of our medications is based on a rigorous scientific review by the U.S. FDA.


The threat is so serious that five former FDA commissioners, whose tenures span the last quarter century and who were appointed by Democratic and Republican presidents alike, have found common cause by voicing their objections directly to the Senate and House Armed Services Committees. In addition, in a rare display of bipartisanship, Democratic and Republican members of Congress have worked together urgently to address the problem, and have crafted a solution that is acceptable to the Pentagon and the FDA.

There’s just one problem: the NDAA freight train is barreling down the tracks toward final floor action, and the solution sits marooned, waiting for a legislative vehicle to get it over the line.

Ever since the Pure Food and Drug Act was passed in 1906, Congress has worked to ensure that American consumers — including our armed forces personnel — are protected from snake oils and too-good-to-be-true cures that aren’t based on sound scientific evidence. Amended over the years, this requirement has since 1962 entailed a rigorous FDA review of drug safety and effectiveness, often involving review of raw data submitted by companies in support of their products. This review has protected Americans from many products that took the lives of residents of foreign countries, but were never approved here.

As the old legal adage goes, hard cases make bad law.

The NDAA provision arose because of controversy over how long the FDA has taken to review and approve a freeze-dried plasma product for combat use.

The proposed solution? Five external reviewers would advise DOD on whether the use of such drugs and devices is safe and effective for U.S. troops. Is there any way for them to have the same knowledge of chemistry, physiology and manufacturing as entire divisions of FDA scientists and doctors who have spent years studying individual classes of drugs and medical devices? Will they have access to the raw data of clinical trials or the expertise to analyze them? Will they be able to monitor the post-market effects of these drugs and medical devices? No, no and no.

That’s why the former FDA commissioners declared in their letter that “medical innovation for these personnel is best served by utilizing the expertise and support that the FDA brings to medical product development.”

And that’s what the bipartisan group of lawmakers, working with the Pentagon and the FDA, have achieved. Their solution provides for speedy and close collaboration between FDA reviewers and a medical product’s manufacturer when the Pentagon identifies a needed drug or medical device, as well as ongoing communication before emergencies arise. What’s more, military personnel, like other Americans, can use the FDA’s expanded access program, which annually provides access to unapproved drugs and devices to hundreds of people.

There seems to be a will to fix this problem. Can Congress find a timely way as it considers the bill?

Peter G. Lurie is the president of the Center for Science in the Public Interest.