Alexandra Murphy
FDA releases 200+ rejection letters to drugmakers
The FDA published a database containing more than 200 letters to pharmaceutical companies detailing why the agency initially refused to approve their products, The New York Times reported July 10.
FDA officials described the move as a form of “radical transparency.” The documents, known as complete response letters, outlined early concerns about drugs that were eventually approved. Letters about products that were never approved were not included.
“For far too long, drug developers have been playing a guessing game when navigating the FDA,” said Marty Makary, MD, the agency’s commissioner, in a statement to the Times. “Drug developers and capital markets alike want predictability.”
HHS spokesperson Andrew Nixon acknowledged that many of the letters were public already, but said it is the first time a centralized database has been made available.
A review of the letters addressed to companies showed that they often revolved around problems discovered in manufacturing facility inspections and others outlined concerns about drug safety or effectiveness.
One letter showed why the agency initially declined to approve testosterone drug Jatenzo, then being developed by company Clarus Therapeutics. The letter said the drug could increase blood pressure, raising the risk of major heart problems and concluded that the drug’s risks outweighed its benefits.
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FDA floats fast-track incentives for drugmakers that lower prices
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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