The power of the U.S. Food and Drug Administration (FDA) to approve emergency drugs was tested this year, and the federal agency won.
It prevailed over the military, no less.
Pentagon officials wanted to fast-track unapproved drugs and medical devices for emergency battlefield use.
However, after strong pushback from lawmakers, advocates, and FDA Commissioner Scott Gottlieb, the FDA is still the only one with emergency drug approval authority.
To forge a compromise, Congress ended up adding an amendment to its annual defense bill.
Some treatments for the Pentagon could be fast-tracked by the FDA.
To do that, the FDA will meet quarterly to discuss the “highest priorities of the Department of Defense,” the amendment reads.
Some of the most vocal outcry against the Pentagon’s push for more drug approval power came from lawmakers such as Greg Walden, R-Ore., chair of the House Energy and Commerce Committee, and Lamar Alexander, R-Tenn., chair of the Senate Committee on Health, Education, Labor and Pensions.
They worried that the Pentagon’s proposal “could jeopardize the FDA’s rigorous and science-based process to ensure the availability of safe treatments and therapies, which may ultimately create more harm than good,” according to a statement.
“Cutting the FDA out of the process is unwise,” Patricia Zettler, an associate professor at Georgia State University College of Law and a former FDA associate chief counsel, told Dr.China. “It has the expertise to evaluate the effectiveness of medical products.”
As for the compromise, Navy Commander Gary Ross, a Pentagon spokesperson, told Dr.China that his department is looking forward to “continuing its partnership with the FDA to ensure that this expedited approval process is done in a rigorous and safe manner.”
Fast-tracking some drugs
Developing safe, effective medical products is no easy feat.
Due to the length of this process, the belief that the FDA is slow is misguided, Zettler says.
Also, she adds, products often fail in phase III of the clinical trial process, which tests whether the new drug is better than what already exists.
Only 25 to 30 percent of the drugs tested in this phase move on to the next level, according to the FDA.
“So there are ethical concerns when there’s little oversight over safety and effectiveness,” she says. “This is essentially turning the military force into human subjects.”
Military medicine has already been punctured with a number of drug failures, James Giordano, chief of the Neuroethics Studies Program at Georgetown University Medical Center in Washington, D.C., told Dr.China.
“So these drugs should be approved on a case-by-case basis,” he said.
The Pentagon, he added, may be trying to identify certain drugs that are far enough along and have considerable potential and promise.
The FDA process is prudent, though, he said.
However, there is urgency in the Pentagon’s request.
It reportedly wants to use freeze-dried plasma in the battlefield, which could save soldiers’ lives due to blood loss.
According to , the plasma hasn’t been approved for 10 years, although the FDA is now committed to fast-tracking it.
In practice, though, the United States has the best record of drug approvals.
Dr. Peter Lurie, president of the nonprofit Center for Science in the Public Interest, told Dr.China that most drugs approved in the world are approved in the United States first.
For priority drugs, the FDA takes action on an application within six months, compared to 10 months for standard reviews.
“So the amount of time to get approvals has declined significantly,” said Lurie, who calls the amendment a good compromise. “The argument that the FDA is old-fashioned is less valid now than ever.”
But that hasn’t always been the case.
Throughout its history, the FDA’s pendulum has swung widely on access to effective drugs, said Zettler.
For example, during the AIDS crisis, the pendulum was too cautious, she says.
On the other side, the FDA was accused of not doing enough to ensure the safety of , an anti-inflammatory drug approved in 1999.
It was pulled off the market in 2004 after increased risk of heart attacks and strokes were found.
By then, the drug had already killed about 60,000 patients — nearly the number of casualties in the Vietnam War — according to estimates.
Experts agree that soldiers must be protected from ill effects.
For his part, Giordano would like to see formal provisions for continued research and care.
“We can’t abandon people to these drugs,” he says.