FDA again approves record-breaking number of generic drugs


The Food and Drug Administration approved or tentatively approved a record-setting 971 generic drugs in fiscal year 2018 that ended last month, the agency announced on Thursday.

The total figure is slightly above the 937 final and tentative approvals in fiscal 2017, which itself was also a record. Generics are copies of brand name drugs and typically much cheaper. The Trump administration has pinpointed quickening generic drug approvals as a key way to bring down prescription drug costs.

“We’ll continue taking additional steps to help ensure patients have access to the drugs they need by making generic drug approval more efficient and predictable,” said FDA Commissioner Scott Gottlieb in a statement.

The FDA noted the high number of complex generic drugs that were approved in fiscal 2018, saying that 12 percent of the approvals were for complex products.

“We also will continue our focus on helping to bring more generic versions of complex drugs, like EpiPen, to the market,” Gottlieb said, referring to the allergy drug EpiPen of which drugmaker Mylan spiked the price in recent years. “In too many cases, there is no generic competition for these costly branded drugs even after they have lost their exclusivity protections.”

[Opinion: Free market reforms can fix the problem of generic drug price spikes]

The agency said it did not list a percentage of complex generics approved in fiscal 2017 and 2016 because they were not available.

Altogether, the FDA approved 781 generic drugs and tentatively approved 190 more in fiscal year 2018, which ended on Sept. 30.

A generic drug cleared under tentative approval cannot be marketed in the U.S. because it is a copy of a drug that is still protected by market exclusivity. But the drug can be sold in developing countries.

A tentatively approved generic can be sold in the U.S. right after the brand name drug loses market exclusivity.

The FDA has made a concerted effort in recent years to boost generic drug approval times. In 2012, Congress passed a law that let the agency collect user fees from generic drugmakers. The FDA used the revenue from the fees to hire more staff and speed up generic review times.

The user fee program was reauthorized in 2017 with new regulations aimed at hastening generic drug approvals.



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