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STAT | PHARMALOT

Congress considers risky choice to speed up drug approval for military use

CAROLYN KASTER/ASSOCIATED PRESS

Some ideas are bad. Others are simply terrible.

A group of congressional lawmakers has found a way to put military personnel at risk and undermine regulatory standards for approving medicines — all at once.

Under legislation that was crafted by House and Senate negotiators, a special US Department of Defense panel would be authorized to approve certain drugs and devices for emergency use when members of the armed forces confront “agents of war.”

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This may be a well-intentioned idea, but putting it into practice would be a colossal blunder.

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Before explaining why, let’s first acknowledge that the rationale is noble.

A 2003 law already allows the Defense Department to ask the Food and Drug Administration to approve medical products for emergency use — without going through the usual review — in the event that military forces are attacked with biological, chemical, radiological, or nuclear agents. But the lawmakers behind the new proposal are concerned soldiers might die unless more drugs and devices are approved for more common battlefield situations.

An example cited is freeze-dried plasma, which is easier to carry in backpacks than other blood products and does not require refrigeration. The military is currently buying plasma from a French company, but it wants a domestic manufacturer to ensure availability. An official with the Health and Human Services Department says that FDA approval could come next year.

Nonetheless, critics call the current FDA approach to approving critical battlefield drugs too slow. By letting the Pentagon take the lead, the new bill could “lead to even higher survival rates from severe battlefield wounds,” according to a Senate Armed Services Committee conference report.

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In general, complaints about pushing the FDA may be valid, but this workaround would create a sort of alternative universe, causing a new and potentially disturbing set of problems.

For one thing, the FDA already has the resources and expertise to assess medical products for safety and effectiveness. It’s hard to see how the Defense Department and its panel could match this. To mollify any concerns, the lawmakers would have the five-member panel consult with FDA officials, but that is hardly a substitute for full-blown staffing.

And this is a point that five former FDA commissioners correctly tried to explain in a letter last Thursday to the leaders of the House and Senate Armed Services Committees.

“These five external advisers are not likely to have the requisite knowledge about the chemistry, manufacturing, and controls that are part of every FDA review, nor will they have access to the raw data that are part of every new product application to the FDA,” they wrote. They also stressed that current law gives FDA sole authority to approve drugs and devices.

There may be an unforeseen consequence as well. The Defense Department panel could effectively transform military personnel into clinical trial participants.

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How so?

The legislation refers to approving products to counteract “agents of war,” but there is no legal definition for this term, which means the Defense Department could approve a wide range of drugs and devices. And since the Defense Department would not have access to FDA data, the special panel might end up green-lighting products based on limited evidence, primarily from drug and device makers.

This is a problem. As the former FDA commissioners noted, the legislation doesn’t rule out emergency use of medical products that are still under development, which is no guarantee of success.

Earlier this year, for example, the FDA issued a report showing nearly two dozen instances in which unpleasant surprises appeared in Phase 3 testing, the large studies designed to assess benefits versus risks. Instead of verifying results of earlier Phase 2 studies — which involve smaller groups of patients — these late-stage studies failed to confirm safety or effectiveness.

“Essentially, it looks like this [legislation] would [allow] non-voluntary experimentation on soldiers,” said Alexander Major, a retired Air Force intelligence officer who is now a partner at the McCarter & English law firm, which represents drugmakers, among others. “How do we want to perceive our troops — as lions or guinea pigs?”

Rather than create a new apparatus that would short-circuit an existing system of checks and balances, it would be smarter to make changes to existing laws or arrangements.

For instance, the FDA and Defense Department already have a decades-old memorandum of understanding for investigational use of drugs and devices. That could be updated. Or a law could be written to require FDA to expand emergency use authorization to so-called battlefield drugs.

“The best course of action is for the agencies to work better together, not cut the FDA out of the picture,” said Patti Zettler, a former FDA associate chief counsel who is now a Georgia State University College of Law professor.

Indeed, a compromise may yet get worked out to require the FDA to take action if the Defense Department seeks an expedited review.

To be sure, ensuring that needed medicines are available for military personnel should be a priority. But the legislation would undermine a longstanding approach to product approvals that is designed to serve everyone.

The bill, as it stands, is bad policy and might just create a battlefield of its own.

Ed Silverman can be reached at ed.silverman@statnews.com. Follow him on Twitter @Pharmalot. Follow Stat on Twitter: @statnews.