Clash over drugs
Defense bill would allow combat troops to use unapproved pills, devices
The FDA is battling a Pentagon proposal to use emergency drugs and devices that the FDA hasn’t approved.
Should the Pentagon be allowed to authorize the use of unapproved drugs and medical devices on an emergency basis for combat soldiers?
That question has sparked a furious battle this week among some of Washington’s biggest power players, with the Defense Department and its congressional advocates on one side and the Food and Drug Administration and the health committees on the other.
The Capitol Hill clash was set off by a provision in the annual defense authorization bill that would allow the defense secretary to authorize the emergency use of drugs and devices that have not been approved by the Food and Drug Administration. The permission would apply to military personnel who are outside the United States.
The FDA has the sole authority to make decisions on medical products, including during an emergency. The Defense Department can ask the FDA to grant an emergency authorization to use unapproved drugs and devices if there is a threat of a chemical, biological, radiological or nuclear agent.
The FDA and leaders of congressional health committees say that giving the Pentagon the authority to decide whether to use unapproved drugs and devices could expose soldiers to dangerous products. Members of the defense panels and the Pentagon say that the measure would save lives by ensuring that soldiers in combat situations get cutting-edge treatments.
Capitol Hill talks to resolve the dispute are now underway. The FDA and the leaders of the health committees favor a different approach that would create an expedited process for the Pentagon’s emergency-use requests. That would be similar to the FDA’s “breakthrough” designation for promising drugs for serious or lifethreatening conditions. If lawmakers agree on new language, it could be offered as an amendment to the defense bill or in future legislation. The House-Senate conference report filed Wednesday, which includes the provision to allow unapproved drugs and devices, could be voted on by the House as soon as next week.
FDA Commissioner Scott Gottlieb on Tuesday expressed unhappiness with the defense-bill language, saying medical-product approvals should be kept under his agency's control.
“We think we provide a level of oversight that helps ensure the safety of products, helps follow up to make sure that if there are adverse events we’re monitoring them; we’re collecting that information,” he said.
Navy Cmdr. Gary Ross, a Pentagon spokesman, said the Defense Department, if given the emergency authorization, would exercise caution. “If DOD is given this authority, we would work closely with our FDA colleagues to ensure lifesaving treatments are fielded quickly while protecting patient safety,” he said.
Under the defense bill’s language, the Pentagon would be required to create a panel of outside experts to recommend when an unapproved product should be used, and defense officials would have to consult with the FDA — but would not have to follow its advice.
Congressional supporters of the provision say lawmakers are frustrated over what they see as FDA delays in approving freezedried plasma, a dehydrated form of plasma that is intended to be quickly reconstituted and given to soldiers during military operations. Such plasma is being used by a small number of U.S. troops under limited permission from the FDA, and by some U.S. allies.
Gottlieb said that the FDA could approve the plasma as soon as 2018, more quickly than if the Pentagon had to develop its own review process.
The Pentagon provision has strong support among defense committee lawmakers of both parties, including Senate Armed Services Committee Chairman John McCain (R-Ariz.); ranking Democrat Sen. Jack Reed (R.I.); House Armed Services Committee Chairman Mac Thornberry (R-Tex.), and ranking Democrat Adam Smith ( Wash.).
In a letter to those lawmakers Thursday, five former FDA commissioners who served in both Democratic and Republican administrations — Margaret Hamburg, Jane Hanney, David Kessler, Mark McClellan and Andrew von Eschenbach — denounced the provision and said it “likely increases the risks for our military personnel.”
Lawmakers who support the FDA position include Sen. Lamar Alexander (R-Tenn.), chairman of the Health, Education, Labor and Pensions Committee; Sen. Richard Burr (R-N.C.), chairman of the Intelligence Committee; and Rep. Greg Walden, (R-Ore.), a member of the House Energy and Commerce Committee.
Michael Carome, director of Public Citizen’s Health Research Group, said it is a “horrible idea” for the Pentagon to get authorization to use unapproved materials on troops. “It will endanger the FDA’s authority and endanger the soldiers,” he said.
“It will endanger the FDA’s authority and endanger the soldiers.” Michael Carome, director of Public Citizen’s Health Research Group
FDA chief Scott Gottlieb objects to a Defense Department proposal to allow the emergency use of unapproved drugs and devices.