FDA Generic Approvals Are Rising Without Plans to Stop


The most recent fiscal year reached a new peak in total approvals — for the 3rd year in a row.

The flooding of generic drugs into the US market, which today makes up about 90% of all dispensed prescription drugs, started because of a drought.

The Drug Price Competition and Patent Term Restoration Act — informally known as the Hatch-Waxman Act — was passed into federal law in 1984. It sought to address the lack of generic options with an expedited and beneficial form of the Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA).

Generic rates exploded over years, from 19% at the time of the law passing to over 50% by 2002. With it now nearing a near-monopolized stake of the market, logic would argue the rate of new generics would slow down.

It’s not slowing down.

According to the most recent FDA data, the administration approved 763 generic drugs in the 2017 fiscal year (October 2016 to September 2017). The rate is an 18.7% boost from the previous fiscal year (651), and is the highest annual rate since the FDA began recording the data under the Generic Drug User Fee Amendments (GDUFA) in 2012.

The approval count is nearly double that of the 2013 fiscal year total (409). In fact, generic approvals exceeded the 2013 rate just midway through the 2017 fiscal year.

Ted Sherwood, director of the FDA’s Office of Regulatory Operations (ORO) in the Office of Generic Drugs, told MD Magazine the annual climb of approvals in recent years is due to a “better match of resources to workload,” and a stronger push of policy language to applicants learning the GDUFA system.

On August 18, President Donald Trump signed into law the Food and Drug Administration Reauthorization Act (FDARA). Informally dubbed “GDUFA II,” the law simply reenacted the expiring GDUFA policies through September 2022.

The FDA is looking forward to building generic approval successes into GDUFA II, Sherwood said. A big part of that is limiting buffer between the administration and applicants.

“We’re certainly focusing on trying to get more info out on products, so manufacturers can read it, digest it,” Sherwood said. “All these pieces will hopefully facilitate getting a better package on day one, and hopefully that all leads to quicker approval.”

Though there aren’t specific hiring commitments in GDUFA II, the FDA told MD Magazine that the reauthorized program increases funding by about 65%, “which will allow us to continue to build the program through hiring and improved programming.”

Along with bolstered funding, the FDA enters the new phase for the first time with commissioner Scott Gottlieb, MD. Prior to Gottlieb’s swearing-in as the 23rd FDA commissioner in May, the administration had approved an average of about 57 generic applications per month. In May through September, the rate jumped to almost 73 per month.

Sherwood attributed the increased rate to a combination of Gottlieb’s support for the program, and GDUFA II new staff members “hitting stride.”

Gottlieb shared intentions earlier this month to implement initiatives to quicken generic approvals even more so. Manufactuer-friendly amenities such draft guidances provided prior to ANDA meeting requests will be aimed at "ensuring that we provide as much scientific and regulatory clarity as possible with respect to complex generic drugs," Gottlieb said in a press release.

Many FDA policies surrounding generic application and approval process are designed to provide guidance to the companies, Sherwood noted. If they’re able to facilitate information, while matching resources to the workload, the rate of generics approved since Gottlieb was appointed should continue, Sherwood said.

“We’ll always have fluctuation month to month, but we certainly expect things to continue to be very good,” Sherwood said.

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