Senators grilled a top Food and Drug Administration official on whether the agency has done enough to lower generic drug prices.
A big concern is the time it takes for generic drugs to be approved by the agency, with senators concerned that the agency hasn’t done enough to reduce a backlog of thousands of drug applications.
“It is taking longer for the FDA to get drugs through the approval process, and according to a survey of generic drug makers, the median approval times have slowed from 30 to 48 months,” said Sen. Lamar Alexander, R-Tenn.
Alexander is chairman of the Senate Health, Education, Labor and Pensions Committee, which held a Thursday hearing on the generic drug program.
Several senators said speedy approval of generic drugs could create competition in the marketplace and lower high prices.
In 2012, the agency had a backlog of about 4,700 applications for generic drugs.
Sen. Orrin Hatch, R-Utah, said, there are still major problems with the time it takes to get a generic in the backlog to the market.
“The approval time has increased,” Hatch said, noting the 48-month figure. “This is eight times longer than the statutory review time called for by the Hatch-Waxman Act.”
The 1984 bill authored by Hatch and former California Rep. Henry Waxman set up a regulatory structure for generic drugs.
Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said the agency has cleared 82 percent of the backlog and plans to clear 90 percent by 2017.
In 2012, the FDA received approval from Congress to start collecting user fees from generic drug manufacturers. In exchange, the agency would eliminate the backlog and reduce the time it takes to act on a generic drug application.
Congress must reauthorize the program by September 2017, and the hearing focused on the reauthorization.
The quicker timeframes started last year, with the FDA supposed to review new applications within 15 months. That drops to 10 months in October.
An important caveat is that the 15-month deadline isn’t the time to get approved, but for the FDA to act on the application. Sometimes the agency has to work with the manufacturer to fix problems with an application.
Sen. Susan Collins, R-Maine, noted that certain generic drugs could be approved faster and asked if the agency could do that to spur competition for a drug whose price has spiked.
That would work for the drug Daraprim, a decades-old drug acquired by Turing Pharmaceuticals last summer. Turing increased the price by 5,000 percent. A reason the company could do that was because the drug doesn’t have any competition.
Woodcock said certain generics could be approved much faster. A speedy approval is usually reserved for first generics, which would be the first generic version of a brand name drug, or drugs that are in shortage. The FDA allows that drug to essentially jump to the front of the line and be reviewed first.
The agency currently doesn’t take into account price when deciding whether a drug gets speedy approval.
Woodcock seemed reticent about speeding up approval of a drug to compete with another drug that has spiked in price. The main problem is there isn’t any clear definition of what price spike triggers action.
“We don’t know what a price spike is,” Woodcock said, asking if a drug price doubling from 10 cents per pill to 20 cents would qualify or if it would be something much larger.
Sen. Elizabeth Warren, D-Mass., was more skeptical that changes to the FDA would help the problem of drug prices.
“We can make some small changes as to how the FDA approves generics,” she said. “But real change will require us to face the fact that the market for prescription drugs is not working.”
