FDA Commissioner Marty Makary, MD, said the agency may fast-track new drugs from pharmaceutical companies that equalize the cost of their medicines between the U.S. and other countries, Bloomberg reported July 11.
“We can issue a national priority review voucher for companies that are promising to equalize the price,” Dr. Makary said in an interview on Bloomberg Television’s “Wall Street Week”. “We want to incentivize good behavior in the marketplace, and these priority vouchers are worth a lot of money.”
The new vouchers would cut review times to one to two months, down from an average of about 10 months to one year, the agency said.
HHS has asked drugmakers to price therapies that don’t have generic competition at the lowest level offered to any member country in the Organization for Economic Cooperation and Development that has an economy at least 60% of the size of the U.S.
Rachel Sachs, a law professor and expert in health law, food and drug regulation and innovation at Washington University in St. Louis, said more detail is needed before the program could be taken seriously.
“There have been concerns raised that this pathway, because it is vaguely defined, would be a mechanism to dole out political favors,” she said. “This adds to that concern.”
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