A proposal to allow the secretary of the Department of Defense (DoD) to authorize emergency use of unapproved medical products by troops in war zones will likely be reversed, to the relief of critics who said that it would have further endangered military personnel.
The proposal is in the nearly $700 billion fiscal 2018 National Defense Authorization Act (NDAA), which was approved by the full House and Senate and then by a joint House-Senate conference committee on November 8. The final legislation is poised for floor votes in both chambers the week of November 13, according to a Senate staffer.
But after a backlash against the emergency use proposal, the DoD and the US Food and Drug Administration (FDA) have reached a compromise in which the Pentagon would no longer have emergency use authority. Instead, the DoD would be required to ask the FDA for an expedited review of products that it felt were needed quickly for the battlefield, said a Senate committee aide. An FDA spokesperson declined to comment, noting that the agency generally does not comment on pending legislation.
The compromise stems in part out of concerns voiced by House Energy and Commerce Committee Chairman Greg Walden (R-OR), Senate Health, Education, Labor, and Pensions Committee Chairman Lamar Alexander (R-TN), and Senate Select Intelligence Committee Chairman Richard Burr (R-NC).
The original 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 for those who have risked their lives to defend our nation,” they said in a statement.
The legislators helped draft the compromise that they hope to see included in new legislation that would reverse the NDAA proposal.
New legislation is needed because the House and Senate are unlikely to alter the final NDAA bill, said a Senate Armed Services Committee staff member. The Senate and House armed services panels had been satisfied with the proposal in its original form. “The legislation was written in very specific ways to accommodate the priority for patient safety for men and women in uniform, and to balance that with ability to deliver these lifesaving medical technologies to the battlefield,” said the committee aide.
The DoD lobbied for the proposal. “For DoD, the value of a provision like the one now under consideration is about addressing the lack of existing authority to approve combat casualty treatments with the same urgency that now exists regarding chemical, biological, and nuclear threats,” said Gary Ross, commander, US Navy Defense Press Operations, in the Office of the Secretary of Defense.
Ross told Medscape Medical News that the DoD would not ignore the risk to troops. “Patient safety is at the heart of everything we do,” he said. “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.”
The Pentagon had not responded to queries about the compromise at press time.
DoD Not Equipped
The proposal at issue ― Section 716 of the NDAA ― creates a process within the Pentagon “to authorize an emergency use outside the United States of the product to reduce the number of deaths or the severity of harm to members of the armed forces (or individuals associated with deployed members of the armed forces) caused by a risk or agent of war.” Legislation was approved by a joint House-Senate conference committee on November 8 and could receive votes for final approval by both chambers the week of November 13, according to a Senate staffer.
Currently, only the FDA has emergency use authority. It is granted to “sustain and strengthen national preparedness for public health, military, and domestic emergencies involving chemical, biological, radiological, and nuclear agents, including emerging infectious disease threats such as pandemic influenza,” according to the agency.
The current FDA commissioner and five former agency heads ― along with bioethicists and consumer advocates ― objected to the original proposal.
“The last thing we need is an Alt-FDA embedded inside the military,” said Peter Lurie, MD, MPH, president of the Washington, DC-based nonprofit Center for Science in the Public Interest, in a statement.
“The current law is very clear in giving the sole statutory authority for drug and medical device review to the FDA,” wrote the former FDA commissioners ― Margaret Hamburg, MD, Jane E. Henney, MD, David A. Kessler, MD, Mark B. McClellan, MD, and Andrew C. von Eschenbach, MD ― in a letter to the chairmen of the House and Senate Armed Services Committee. The proposal “undermines that longstanding statutory framework and likely increases the risks for our military personnel,” they wrote.
At an unrelated forum on opioids in Washington, DC, on November 7, current FDA Commissioner Scott Gottlieb, MD, said he believed the DoD “has a legitimate concern that FDA historically hasn’t looked at the war fighter and products destined for that setting,” but that it was important to keep emergency use authority at the FDA. “We think we provide a level of oversight that helps ensure the safety of products” and that the FDA also allows for follow-up on adverse events, said Dr Gottlieb.
He said the agency was proposing an alternative that would couple a “breakthrough therapy-like process for products destined for the war fighter with an expansion of FDA’s existing emergency use authorization authority.”
Freeze-dried Plasma the Impetus?
The DoD and the FDA have clashed in the past over expediting products for troops, most recently over a freeze-dried plasma developed in part by the US Army Medical Materiel Development Activity, Fort Detrick, Maryland. The product can be carried in a small vial or pouch and reconstituted on site on the battlefield. French soldiers have been using a product ― manufactured by French Centre de Transfusion Sanguine des Armees ― since 1994. The French freeze-dried plasma has been available on an investigational basis for American troops, but only for US Special Operations Command personnel.
A US product, RePlas, has been under FDA review. Vascular Solutions (now owned by Teleflex Inc), the manufacturer of RePlas, first sought FDA approval in 2016. Dr Gottlieb said he expects RePlas to be on the market by 2018.
A Teleflex spokesman declined to comment on the potential new DoD approval process.
Troops’ Health at Risk?
Under the Section 716 proposal, the secretary of defense could authorize the emergency use of an unapproved product or unapproved use of an approved product for personnel at the battlefront, but only if a specially formed commission recommended it, and only after consulting with the FDA commissioner on the available evidence.
Critics said they saw both a usurping of the FDA’s authority and the potential for troops to be put even further in harm’s way.
“This is so dangerous,” said Adil Shamoo, PhD, a professor of biochemistry and molecular biology and editor of Accountability in Research. Dr Shamoo, who was a member of the Defense Health Board’s ethics committee from 2006 to 2010, told Medscape Medical News that the proposal would in effect make military personnel clinical trial subjects, especially if the products were not far along in the development process, as would be expected.
“When you don’t have a clinical trial, it’s really a crapshoot,” said Dr Shamoo.
“I’m concerned that those people who are putting their lives at risk for our country might have their lives further endangered by the failure to properly vet the medications that they would receive,” Dr Lurie said.
Dr Lurie, who was previously associate commissioner for public health strategy and analysis at the FDA, said the proposal also “undermines literally a century of practice in which the Food and Drug Administration has taken the responsibility for the approval of medical products.”
Having been at the agency gave him an “appreciation of the complexity of a drug review,” he said. Thousands of employees investigate questions about chemistry and pharmacology and address manufacturing issues, safety, and effectiveness. The FDA also has access to a manufacturer’s raw data ― something that a DoD commission could not access, he said.
“They cannot exercise the degree of scrutiny over the data that the FDA could,” Dr Lurie said.
Dr Lurie said he supported the alternative approval path proposed by Senator Alexander and his colleagues.
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