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The New Jersey Life Sciences Vendors Alliance (NJLSVA) is a coalition of businesses, individuals and academia who provide goods and services to New Jersey’s life sciences companies.

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Controversy Erupts Over Congressional Plan to Let Pentagon Bypass FDA and OK Unapproved Drugs for Battlefield Use

Washington, DC, November 10, 2017 — Should the Pentagon be allowed to authorize the use of unapproved drugs and medical devices on an emergency basis for combat soldiers?

That question, Laurie McGinley reports in The Washington Post, has sparked a furious battle this week among some of Washington’s biggest power players, with the Defense Department and its congressional advocates on one side and the Food and Drug Administration (FDA) and the health committees on the other.

The Capitol Hill clash was set off by a provision in the annual defense authorization bill.

The provision would allow the secretary of defense to authorize the emergency use of drugs and devices that have not been approved by the Food and Drug Administration (FDA).  T

The permission would apply to military personnel who are outside the United States.  The purpose, the bill says, would be “to reduce the number of deaths or the severity of harm to members of the armed forces…caused by a risk or agent of war.”

Under current law, the FDA has the sole authority to make decisions on medical products, including during an emergency.

However, the Defense Department can ask the FDA to grant an emergency authorization to use unapproved drugs and devices if there’s a threat of a chemical, biological, radiological or nuclear agent.

The FDA and leaders of congressional health committees say that giving the Pentagon the authority to decide whether to use unapproved drugs and devices could expose soldiers to dangerous products.

But members of the defense panels and the Pentagon argue that the measure would save lives by ensuring that soldiers in combat situations get cutting-edge treatments.

Capitol Hill talks to resolve the dispute are now underway.

The House-Senate conference report, filed Wednesday, which includes the provision to allow unapproved drugs and devices, could be voted on by the House as soon as next week.

For McGinley’s full story, click here.