Partner Joel Wallace was quoted on how the government shutdown could impact the drug industry if the U.S. Food and Drug Administration (FDA) runs out of funding.
The FDA predicts it can continue generic drug reviews for a number of months. But generic drug product launches are also contingent on a parallel process related to the lifetime of patents and exclusivity periods that plays out in the courts, which also do not have fiscal 2019 funding.
Joel said that generic drugmakers, who usually make money from drug supply-chain intermediaries, risk a business disruption if they can’t meet a deadline specified in a contract.
“You run risks of generics missing these agreed-upon launch dates that they’ve been planning around for possibly years,” he said.
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