Skip to Main Content

Under pressure to speed approval of generic medicines, the Food and Drug Administration last week released data to defend its progress. And while industry watchers say the statistics indicate the agency is making headway, there are also clear signs the FDA continues to struggle with the workload.

On the bright side, the number of full and tentative drug approvals has been rising each month since last April and reached 99 this past December, which is the largest tally ever issued in a single month, according to FDA watchers. They note the agency also appears to be doing a better job of communicating with generic drug makers about their applications.


“Overall, there’s some improvement,” said Robert Pollock, a former acting deputy director of the FDA Office of Generic Drugs, who now works at Lachman Consultants and advises drug makers on regulatory matters. “But the question is can it be sustained, and will there be progress beyond what we’ve seen.”

Generic drug approval is gaining more attention thanks to the intensifying national debate over the rising cost of prescription medicines. Although prices have also risen for some of these copycat medicines, generics remain — by and large — lower-cost alternatives to brand-name drugs. And generics now account for 88 percent of all prescriptions written in the United States, according to IMS Health.

This explains why FDA performance is of increasing interest. In response to the scrutiny, Dr. Robert Califf, who last week was confirmed as the agency’s commissioner, acknowledged that accelerating generic approvals is high on his list of priorities. Although Adam Fein of Pembroke Consulting, who tracks pharmaceutical distribution, contends the increasing number of approvals is starting to temper the price hikes for generic drugs.


But historically, the FDA has been unable to keep up with the pace of marketing applications filed by generic drug makers. And so, four years ago, the FDA was authorized to start collecting fees from generic companies to fund two key goals – increase the number of facilities to be inspected, especially overseas, and increase the rate at which applications to market generics are reviewed.

So far, the FDA has collected about $1.5 billion in fees and hired about 1,000 additional employees, but some contend the agency has failed to make sufficient progress in approving generics. Last week, for instance, US Senator Tom Cotton (R-Ark.) wrote the FDA to complain that there has been an overall decrease in approvals and an increase in the amount of time the agency takes to review applications.

In particular, he noted there continues to be a large backlog of applications. Indeed, the FDA is staring at about 4,000 applications that have yet to be approved, according to Pollock. Although the agency recent told Congress the backlog is slowly dissipating, Pollock pointed out that the FDA is actually referring to a so-called first review, not an approval.

“The FDA is being a little disingenuous saying its backlog is almost cleared,” he told us.

Meanwhile, the Generic Pharmaceutical Association is circumspect. A spokesman for the trade group would only say that “we are seeing some progress, but more can be done. (We are) eager to see actions taken by the agency translate to approvals.” He declined further comment while the industry is holding talks with the FDA about setting the latest round of fees.

The FDA faces yet another challenge – the increasingly large number of applications that drug makers are submitting. In 2012, the agency estimated about 750 would be filed each year, but more than 4,000 have been filed in the past four years, or 1,022 annually, on average. And Pollock estimates a similar number will be filed this year, suggesting the FDA workload will not abate.

The upshot is that the rate at which new generics will find their way to pharmacy shelves is unclear — and that adds further uncertainty for health care budgets.