The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States.
It could cut down the time from 10 to 12 months for a review to just one.
The pilot program, known as the Commissioner’s National Priority Voucher program, could drastically change the way pharmaceutical drugs reach the public and significantly cut down the time in the process for pharmaceutical companies.
“To reinvigorate innovation, we must become a user-friendly FDA that partners with industry rather than takes a receive-only posture. Such a close relationship can provide guidance and predictability to developers and investors,” said Dr. Marty Makary, new FDA commissioner. “In the case of small companies, the FDA can provide the regulatory navigation that companies may lack internally. At the same time, the FDA will guard against a cozy relationship that has characterized the agency in the past and led to allegations of industry capture. The scientific evaluation of products will always remain strictly independent.”
Makary said the vouchers will be given to some drug companies to help streamline the review processthat can take up to a year and bring it down to just one month.
“By taking that review time down to one month, we think that has significant incentives for a company to play ball with our national priorities,” he said.
Those new national priorities include increasing domestic drug manufacturing, addressing the affordability of drugs in the United States and doing more to meet public health needs, Makary said.
“We’d like to reward good behavior in the marketplace, and a more rapid review that is, say, a one-month turnaround time for a final drug application is worth well over $100 million in market value,” he said.
When asked about concerns by going from 12 months to one month for the review process and if it will compromise the safety of these drugs, Makary responded, “We’ve done everything humanly possible to make sure we’re still doing the same scientific review, but in a much more efficient way.”
He previously spent two decades at Johns Hopkins University in Baltimore, where he specialized in pancreatic surgery and public policy research.
He insists the new voucher program is about cutting red tape using artificial intelligence to more rapidly go through lengthy documents and making FDA review personnel more accessible. It is somethingsome say will be difficult given the more than 3,000 jobs recently cut at the FDA, several of which Makary said he’s since brought back, though he stands firm on the new direction he hopes to take the agency.
“The FDA is not supposed to be your doctor, and it’s not our job to censor Americans. So we’re getting back to our core mission of reviewing products and making determinations of what’s safe and effective, “ Makary said.
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