by Brian Shilhavy, Health Impact News:
While HHS Secretary Kennedy has promised more rigorous study of drugs using higher standards and returning to the “Gold Standard of Medical Research” before they are approved, his FDA is doing the exact opposite.
In a Press Release today from the FDA, Commissioner Dr. Marty Makary announced that they were now going to begin offering “vouchers” to “companies supporting U.S. national interests” for new drugs being introduced to the market, and that voucher will shorten the drug company’s review time from approximately 10-12 months to only 1-2 months.
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FDA NEWS RELEASE: FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests
Excerpts:
The U.S. Food and Drug Administration today announced its Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans.
The new voucher may be redeemed by drug developers to participate in a novel priority program by the FDA that shortens its review time from approximately 10-12 months to 1-2 months following a sponsor’s final drug application submission.
The new CNPV process convenes experts from FDA offices for a team-based review rather than using the standard review system of a drug application being sent to numerous FDA offices. Clinical information will be reviewed by a multidisciplinary team of physicians and scientists who will pre-review the submitted information and convene for a 1-day “tumor board style” meeting.
“Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies. The ultimate goal is to bring more cures and meaningful treatments to the American public,” said FDA Commissioner Marty Makary M.D., M.P.H.
In a recently published JAMA medical journal article, the FDA Commissioner said he wanted to copy the truncated process used to authorize the first COVID-19 vaccines under Operation Warp Speed.
From the Associated Press:
Since arriving at the FDA in April, Makary has repeatedly told FDA staff they need to “challenge assumptions” and rethink procedures.
In a medical journal commentary published last week, Makary suggested the agency could conduct “rapid or instant reviews,” pointing to the truncated process used to authorize the first COVID-19 vaccines under Operation Warp Speed.
For the new program, the FDA will issue a limited number of “national priority vouchers” to companies “aligned with U.S. national priorities,” the agency said in a statement.
The special designation will give the selected companies access to extra FDA communications, streamlined staff reviews and the ability to submit much of their product information in advance.
Speeding up drug approvals has long been a priority of the pharmaceutical industry, which has successfully lobbied Congress to create a variety of special programs and pathways for faster reviews.
Many aspects of the plan announced Tuesday overlap with older programs. But the broad criteria for receiving a voucher will give FDA officials unprecedented discretion in deciding which companies can benefit from the fastest reviews.
Makary previously said the FDA should be willing to ease its scientific requirements for certain drugs, for instance, by not always requiring randomized studies in which patients are tracked over time to track safety and effectiveness.
Such trials are generally considered the gold standard of medical research. (Full Article.)
This announcement should not be too surprising, given that Mr. Kennedy stated publicly that he supported Operation Warp Speed under Trump 1.0, and would do so again. (Source.)
This new policy by the FDA eliminates the need to invoke a “national health crisis emergency” as Trump did with the PREP Act back in 2020.
Now he can just choose which drug companies he wants to give federal funds to so they can rush their products to market, and basically use the American public as the third phase of the drug trials to see how many people these new “novel” drugs injure and kill, before making adjustments.
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