New York, NY -- (SBWIRE) -- 11/09/2017 -- The U.S. Department of Defense may soon be armed with the right to approve drugs and devices that it deems essential to protecting U.S. troops, according to a recent Politico article. To date, the U.S. FDA has been the only government agency with the authority to approve drugs and devices. Section 732 of the National Defense Authorization Act, currently in the Senate, could change this fact. Such a seismic shift in healthcare regulation could have a huge impact on Pluristem Therapeutics' pipeline of cell therapies. Pluristem's PLX-R18 product has shown efficacy in the treatment of Acute Radiation Syndrome (ARS) and is currently being evaluated by both the Department of Defense and National Institutes of Health as a countermeasure for nuclear catastrophes including a potential nuclear attack, a dirty bomb, on a Fukushima-like accident.
Emergency use of medical products is something the FDA already has authority to approve, if there is a threat of biological, chemical, radiological, or nuclear attack. The Pentagon may soon gain the same power and be in a position to take faster action on the front lines.
Threats from North Korea could be a catalyst to make countermeasure for ARS front and center at the Pentagon. Section 732 of the National Defense Authorization Act titled, "Additional emergency uses for medical products to reduce deaths and severity of injuries caused by agents of war" is all about defending troops on the front lines.
Anyone in harm's way, not just troops, may be impacted by the new law, according to the Politico article, "…[Section 732] creates a new regulatory structure that would allow the Pentagon to sign off on unapproved devices and drugs for emergency use on military personnel and others in harm's way."
"Traditional pathways to [FDA] approval and licensure of critical medical products, like freeze dried plasma, for battlefield use are too slow to allow for rapid insertion and use of these products on the battlefield," a Senate Armed Services Committee's conference report indicated, as reported by Politico. Freeze dried plasma has been the prime example and a reason for the proposed law in defense circles. If passed, the law would apply to any medical product, including cell therapies. The Pentagon appears to be taking things into their own hands.
Clearly, the Department of Defense is interested in Pluristem's PLX-R18 because it is already conducting studies for the cell therapy in ARS. PLX-R18 works by boosting blood cell production in bone marrow. High doses of radiation can destroy the bone marrow's ability to produce blood cells, leading to a risk of death.
As an off-the-shelf product, PLX-R18 is ideally suited for rapid deployment in large populations in case of a nuclear emergency because it can be administered without prior testing of individuals for their level of radiation exposure.
A pivotal study for FDA approval in ARS under the Animal Rule and potential orders for government stockpiles were considered the next step for PLX-R18 in ARS. However, if the National Defense Authorization Act passes with Section 732 intact, then the Department of Defense could speed up PLX-R18's approval. Pluristem and each of its cell therapy products and indications, including those in Phase III, would benefit.
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About Ray Dirks
Ray Dirks came to Wall Street with Goldman, Sachs & Co. in 1963 where he was established as the leading insurance stock analyst dealing with institutional investors and high -net worth investors both in the U.S. and internationally. In 1973 Ray uncovered the biggest Ponzi scheme of the 20th century, the Equity Funding fraud. Over the years Ray has expanded his stock market research to include Healthcare Stocks and Special Situations. Ray has written two books, "The Great Wall Street Scandal" and "Heads You Win, Tails You Win", published by McGraw-Hill and Bantam Books respectively. He continues to provide research to institutions and individuals, and he manages money for some individual investors.
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