The U.S. House of Representatives yesterday approved a measure that would create a fast track at the FDA for medical devices and drugs intended for treating battlefield injuries, a day after passing a nearly $700 billion defense policy bill that would have allowed Defense Dept. to approve the treatments without the FDA’s participation.
That provision last week alarmed congressional health and Health & Human Services Dept. staff, who claim it could erode medical safety, putting U.S. soldiers at risk. The defense bill passed Nov. 14 included a rider delaying the defense bill’s advance until a compromise was hammered out over the approval question.
That compromise expands the FDA’s authority to approve the emergency use of unapproved medical treatments and aims to expedite the approval process, according to The Hill. In a bid to force the Senate’s hand on the compromise, the House will not advance the defense bill unless the second FDA bill is passed without amendments, the website reported.
“Our men and women in uniform have put their lives on the line for this country, and they deserve to have the earliest possible access to medical products that could save their lives on the battlefield,” Energy & Commerce Committee chairman Greg Walden (R-Ore.) said yesterday, according to the site. “We found a good balance with our friends on the Armed Services Committee, and in working with the FDA and the leadership of the Pentagon.”
“Although we still have concerns about the impact it would have on our men and women in the field, we are content to let this compromise move forward in the hopes of improvement,” Reps. Mac Thornberry (R-Texas) and Adam Smith (D-Wash.) said in prepared remarks this week, The Hill reported. “To be clear, if the Armed Services Committee do not see evidence that the FDA is doing a better job meeting the needs of our troops, we will not hesitate to take action.”
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