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The Food and Drug Administration on Nov. 6 awarded six companies vouchers that will accelerate the review process for their products.
“National priority vouchers are granted to a select group of products where the company has agreed to increase affordability, domesticate manufacturing as a national security issue, or address an unmet public health need,” Dr. Marty Makary, the FDA’s commissioner, said in a statement. “We are pioneering new ways of bringing these cures and meaningful treatments to the market faster.”
Regular drug reviews can take about a year. Under the pilot program, companies that receive vouchers are promised to receive decisions on applications within months, provided certain criteria are met.
The six drugs to receive vouchers for an accelerated decision include Bedaquiline, an approved treatment from Johnson & Johnson for drug-resistant tuberculosis, for which clearance is being sought for young children, and Casgevy, a sickle cell disease drug from Vertex Pharmaceuticals that is already available for many people.
The other vouchers were granted to GlaxoSmithKline’s Dostarlimab for rectal cancer; two weight loss medications, Eli Lilly’s experimental product called Orforglipron and Novo Nordisk’s Wegovy; and Zongertinib, from Boehringer Ingelheim Pharmaceuticals, for lung cancer treatment.
The vouchers were announced on the same day President Donald Trump said Eli Lilly and Novo Nordisk had committed to reducing prices for their weight-loss medications.
The products, part of a new class known as GLP-1, will be available to the public at a nearly 90 percent discount starting in January, including at $149 for the starting dose, officials said. The companies will also sell the drugs at a lower cost to Medicare and Medicaid.
“Through this pilot, companies will receive a decision within a month or two, as opposed to the typical 10 to 12 months,” Makary said at the time.
“One of the criteria for who will get a national priority voucher, which is designed, by the way, for companies acting in our national priorities, is to reward companies that equalize their price with other OECD [Organization for Economic Co-operation and Development] countries,” Makary told The Epoch Times. “Other criteria include companies or drugs that are meeting a large unmet public health need.”
Critics say the program is dangerous.
“Research has shown that when the FDA rushes to review and approve new drugs, there is a higher likelihood that these drugs will have safety problems after approval,” Dr. Robert Steinbrook, a director for the nonprofit Public Citizen, said in a statement.
The FDA in October unveiled the first nine vouchers. They included teplizumab, a monoclonal antibody from Sanofi for Type 1 diabetes, a gene therapy from Regeneron called DB-OTO for deafness, and Pergoveris from Merck for infertility.
