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WASHINGTON — Somewhere in the depths of the Food and Drug Administration, applications for 4,300 generic drugs are awaiting approval.

With growing dissatisfaction over the price of prescription drugs, that backlog has become more than a bureaucratic curiosity. Congress is furious. Hillary Clinton has raised the issue on the campaign trail. And drug makers are threatening to abandon the generics business altogether if the FDA doesn’t speed things up.

The FDA, for its part, blames drug makers for sloppy and incomplete applications that slow the process.


For consumers, the debate might not seem to matter much, but there is no doubt that the availability of generic drugs matters to their bottom line. Sometimes called copycat drugs, generics are between 30 percent and 80 percent cheaper than the original brand-name drugs. They account for 88 percent of all prescriptions in the United States, but only 28 percent of the cost, according to the Generic Pharmaceutical Association.

“The longer it takes for a generic drug product to first get approved or multiple generics for the same product to get approved, the more it costs consumers,” said Robert Pollock, a former FDA generic drugs official who now consults for industry. “If [people] can’t afford to purchase their drugs, the drug can’t do them any good.”


Not all of the 4,300 generic drugs awaiting FDA approval are at the same stage of review. Many have only recently entered the pipeline. But others go back to 2009, since before the advent of a program that was intended to help speed the process.

Political pressure to reduce the number of pending applications has built in recent months. At his confirmation hearing in November, Dr. Robert Califf, President Obama’s nominee to head the FDA, was pressed on the bottleneck by lawmakers. Senator Susan Collins, chairwoman of the Senate’s Special Committee on Aging, said she planned to investigate how much progress the agency has made. The House Committee on Oversight and Government Reform said it is making its own inquiries.

The FDA acknowledges it has had problems in the past. Chronically underfunded, its generic drug office was long the poor stepchild of the agency. But the agency says it has made significant strides, in part because of measures known as the Generic Drug User Fee Amendments.

The 2012 measures required drug makers to pay user fees to help defray the costs of reviewing applications and inspecting facilities. In exchange, the FDA was put on a strict timeline to finish applications that were languishing.

The fees provided an estimated $1.5 billion over five years — enough for the FDA to hire and train 1,000 more staffers for the generic drug office, update its technology, and inspect more manufacturing plants.

How much progress has been made since then depends on how you interpret the data.

The FDA acknowledges that drug applications completed in fiscal 2015 took an average of four years to review, and generic drug companies continue to complain about the lack of progress.

Still, the agency says that its turnaround time has improved and that it has now “acted on” 82 percent of the 2,866 applications that were submitted before the Generic Drug User Fee Amendments took effect. That puts the agency ahead of its statutory deadline. (Just because the FDA has acted on 82 percent of these applications, though, doesn’t mean it has approved or rejected them. In some cases, the agency may have only responded to applicants to request more information.)

More broadly, FDA officials fault drug makers for slowing the process with applications that lack crucial information — about their research, when the original drug will lose patent protection, or relevant court cases.

“Our goal can’t be achieved unless the applications are submitted with high quality,” Hany Edward, acting branch chief, told a group of wary generic drug manufacturers gathered in North Bethesda last month.

In a presentation at the event, FDA officials cited a litany of examples. One applicant seeking to produce a drug for irritable bowel syndrome ignored the propensity of its inactive ingredient to cause diarrhea. Too many generic drug submissions showed a lack of knowledge about medicine or how to make it.

Edward Sherwood, acting director for regulatory operations in the generic drug division, told STAT the agency must push drug companies to keep up with changing standards.

“The more information we have, the more we can do in terms of making sure the bar is set exactly where it needs to be,” Sherwood said. “All applications either hit it, or we can go back and explain what that gap is, and they have a chance to correct themselves.”

But some drug makers complain that the FDA’s changing standards for approval are part of the problem.

“They keep changing the goal posts,” said one industry consultant who spoke on condition of anonymity for fear of angering FDA officials. “A good example is ‘quality by design,’” he said, referring to the agency’s new criteria for good manufacturing processes. “They’d say, ‘Your application isn’t very good because you didn’t have the quality by design concept. But when [the drug] was developed two years before that, quality by design wasn’t a concept of any substance.”

Generic drug makers also complain that less than 1 percent of their applications are approved on the first try. In comparison, applications for new drugs have an 88 percent approval rate.

Sherwood notes that back in 1992, only 27 percent of brand name drugs were approved on the first try, and that over time, better guidance from FDA improved quality of submissions.

“These are very complex types of assessments,” he said. “There are several types of disciplines that all have to evaluate this data to make sure everything is 110 percent understood, so if you take one brand drug on Monday and one generic on Tuesday, you are going to get the same treatment.”

Agency officials also stressed that they are communicating earlier with generic drug applicants than they used to, pointing out flaws in the applications and offering guidance.

Kenneth Phelps, owner of Camargo Pharmaceutical Services, which develops generic drugs, said that he understood FDA’s concern about deficient applications, but that he shared his industry’s concern about how long the process takes.

“We kind of got what we designed, so we should share some of the blame,” Phelps said. “People threw in all kinds of garbage, so the FDA had to wade through the sewage to find out what was good and what was bad. It’s true, the dirty little secret of the generic industry is that they always submitted deficient [applications],” Phelps said. As long as the FDA accepted the applications, companies would “submit and then add the right stuff later.”

“Honestly,” he added, “it was a game.”