A new defense policy bill would give the US Department of Defense the power to approve drugs and medical devices without FDA clearance, according to a report from Politico.
The bill has alarmed congressional health staff and the Dept. of Health and Human Services who claim it could erode medical safety, putting US soldiers at risks, according to the report.
The bill is being backed by House Armed Services Chairman Mac Thornberry (R-Texas) who says the move is necessary to get technologies, like Velico Medical’s freeze-dried plasma, to soldiers on the field.
“The FDA has denied freeze-dried plasma to troops in the fields for 10 years. The Chairman has perfect moral clarity on this provision, and there is no doubt in his mind that it is the right thing to do for the troops,” House Armed Services spokesperson Claude Chafin said, according to Politico.
The FDA disagrees, and thinks the new route to approval as both dangerous and unnecessary, according to the report.
“FDA has been working closely with DoD to bring freeze-dried plasma to our troops and anticipates that these products will be fully approved for safe and effective use for our armed forces as early as 2018,” an FDA official told Politico.
The bill, if passed, would create a new regulatory pathway to allow Pentagon officials to clear previously unapproved devices and drugs for emergency use on military personnel. The bill is expected to get its final language as early as this week, according to the report.
“It’s unprecedented. We’ve never had a process for where an individual agency could [approve] drugs and devices … for its own use. It’s a massive shift,” a Democratic aide who works on medical safety issues said, according to Politico.
Because the language in the bill is so broad, some claim that it could open the door for the military to approve a broad range of products and treatments without FDA oversight, according to the report.
With the bill, two safeguards would be implemented – a DoD committee of health care experts appointed by the Defense secretary would need to recommend emergency use of the drug or device and the assistant secretary of Defense for health affairs would have to authorize its use after consulting with the FDA, according to Politico.
The pathway would remove the need to base approval off years of safety and efficacy evaluations, leaving the entirety of the decision up to a handful of DoD individuals as the DoD would be under no requirement to take the FDA’s advice as necessary, according to the report.
Despite opposition, the provision is expected to remain in the bill as the bill has bipartisan support from defense lawmakers, according to Politico.
The HHS warned Congress that the new law could undermine existing protections which have sold for decades, and create situations where data would be limited and approvals could come entirely based on limited information from drug or device manufacturers. The FDA proposed an alternative route through which device and drug reviews would become expedited upon request of the DoD, but the language was denied.
In September, freeze-dried plasma dev Velico Medical raised $19 million for the Frontline ODP spray-dried plasma product it’s developing.