Tester to FDA commissioner: What’s taking so long on generic drug approvals?

by Missoula Current

It takes the U.S. Food and Drug Administration 47 months to approve a generic drug, and Sen. Jon Tester wants to know why.

Tester this week asked FDA Commissioner Scott Gottlieb if his agency’s budget is seeking the resources needed to address the standing backlog of generic drugs – a backlog Tester says is causing financial strain on thousands of Montanans.

“Montanans shouldn’t have to choose between buying their medications and buying dinner for their kids,” said Tester, a senior member of the Senate Appropriations Committee. “Folks shouldn’t have to empty their pockets for medicine. It’s that simple.”

Tester said that in 2016, nearly 4,000 generic drugs were awaiting approval, though it currently takes the FDA around 47 months, on average, to approve a generic drug.

Tester is asking Gottlieb how he plans to address that delay.

“I’ve held health care listening sessions across Montana and I’ll tell you, the number one thing I hear is that life-saving drugs are too expensive,” Tester said this week. “It’s your job to ease this burden and it’s my job to hold you accountable.”

In recent years, Tester has targeted the nation’s prescription drug prices, sometimes calling out specific companies for questionable price increases. That included Mylan, which raised the price of its EpiPen while moving its tax address to the Netherlands to avoid paying taxes.

Tester also introduced a bill last July to force prescription drug companies to publicly disclose detailed information about price increases on any prescription drug. Pharmaceutical companies are currently not required to release any information to the public after excessively raising the price of a drug, Tester said.