FDA to speed up review of medical products for U.S. military

FDA-logo-newThe U.S. FDA today announced a memorandum of understanding with the Department of Defense to accelerate regulatory assessment of medical products for military personnel.

Congress last year passed a law to expedite regulatory review of products to diagnose, treat or prevent serious diseases or conditions facing U.S. military personnel. The memorandum establishes a framework to implement the 2017 law. It allows the Secretary of Defense to request that FDA speed up the review of investigational submissions, applications for approval/licensure, and submissions for clearance for particular medical products.

Get the full story on our sister site Medical Design & Outsourcing.

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House approves FDA fast track for battlefield treatments

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DoD, PentagonThe 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.”

House passes DoD bill with room to renegotiate drug, device approval provision

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DoD, Pentagon

The US House of Representatives this week passed a nearly $700 billion defense policy bill, but left room for negotiating new terms related to a controversial provision which would have given the Dept. of Defense the power to approve medical devices and drugs without FDA clearance.

The house voted 356 to 70 to approve the $692 billion National Defense Authorization Act, but left room to renegotiate and narrow the provision before the legislation is passed on to the Senate, according to a report from The Hill.

The House approved a rule on Tuesday that requests that the House clerk not send the bill forward until the chamber approves a separate bill to refocus the provision, according to the report.

House Armed Services Committee Chairman Mac Thornberry (R-Texas) and ranking committee member Rep. Adam Smith (D-Wash.) said they support a compromise to allow for expedited FDA approval in military medical emergencies in place of giving the Pentagon the authority to approve drugs and devices that had not been cleared by the agency.

“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 hopes of improvement. To be clear, if the Armed Services Committee does not see evidence that the FDA is doing a better job meeting the needs of our troops, we will not hesitate to take action,” Thornberry and Smith said in a joint statement, according to The Hill.

The provision to the bill last week alarmed congressional health staff and the Dept. of Health and Human Services who claim it could erode medical safety, putting US soldiers at risk, according to the report.

Cardinal Health, Hamilton Medical, Zoll Medical score DoD contracts

U.S. Department of Defense DoD Cardinal Health Hamilton Medical Zoll MedicalCardinal Health (NYSE: CAH) will receive $29.2 million under a new U.S. Department of Defense contract, with Hamilton Medical and Zoll Medical also securing contracts in the tens of millions of dollars.

Cardinal Health’s contract win, announced Sept. 29, comes nearly eight months after Dublin, Ohio–based Cardinal Health secured a $2.25 billion surgical supplies contract renewal with the U.S. military, with Owens & Minor winning another $1.125 billion as part of the deal.

In April, Cardinal Health won a $46.5 million fixed-price DoD contract to supply laboratory supplies and wares.

The $29 million contract announced last week is a nine-month base contract with eight one-year and one 15-month option periods. Customers include the Army, Navy, Air Force, Marine Corps and federal civilian agencies.

Cardinal Health wasn’t the only medtech company scoring multimillion-dollar DoD contracts.

Hamilton Medical (U.S. headquarters in Reno, Nev.) and Zoll Medical (Chelmsford, Mass.) will receive $40.0 million and $30.7 million respectively under five-year contracts for medical equipment and medical equipment spare parts, DoD announced Sept. 29. The contracts have no option periods. Customers include the Army, Navy, Air Force and Marine Corps, as well as the U.S. Department of Health and Human Services.

In other news, biotechnology and regenerative medicine company Humacyte (Research Triangle Park, N.C.) today announced a $3.4 million D0D contract to help support additional clinical sites for Humacyte’s Phase II vascular trauma trial in the U.S. Humacyte has an investigational human acellular vessel called Humacyl. The company announced last week that the California Institute for Regenerative Medicine is giving it $14.1 million to support a clinical trial comparing Humacyl to arteriovenous fistulas.

 

 

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