The U.S. Food and Drug Administration's chief of drug evaluation and research visited Capitol Hill on Thursday to assure lawmakers that the agency is doing a better job processing applications for generic drugs.
Dr. Janet Woodcock updated the Senate Health committee on the progress of speeding up and improving the generic drug approval process outlined by the Hatch-Waxman Act.
As more generics have been manufactured overseas, the approval system has shown signs of strain, Committee Chairman Sen. Lamar Alexander (R-Tenn.) said in his introduction to the hearing.
In 2012—28 years after Hatch-Waxman passed—4,700 generic drug applications sat in backlog while manufacturers waited two and a half years to complete an application. That timeframe in recent years has slowed to four years, Alexander said. The statute gave an expectation of 180-days or roughly six-months.
But Woodcock said the FDA has tried to modernize its system since the delays began roughly three years ago. The agency has since acted on over 90% of the 6,000 applications it has received since 2012. Over 1,700 were approved, or tentatively approved, because of patent obstacles.
Currently, only 600 drugs need to begin the review process and some are recent applications, Woodcock said.
Right now, it takes the FDA an average of 15 months to respond to drugmakers, said Woodcock, who official title is director of the FDA' s Center for Drug Evaluation and Research. She added the agency will have a 10-month review process for the cohort of drug applications that are submitted after September of this year.
One of the reasons the FDA is working hard to bring more generics to the market is because their competitive pressure can lower exorbitant drug prices – the agency even expedites first-generation generic products. Woodcock told lawmakers that currently 99 so-called “innovator drugs” have only one generic competitor, 66 have two competitors and 623 have over three competitors.
Sen. Sheldon Whitehouse (D-R.I.) worried there have been reports of spikes in the costs of some generic drugs due to price manipulation. But Woodcock pointed to an HHS report released Wednesday that found generic drug price spikes to do significantly contribute to the larger drug cost problem. Two-thirds of generic products actually experienced price declines in 2014, the report said.
Another HHS report, released by the Office of Inspector General in December, found that prices rose faster than inflation for 22% of the top generic drugs reviewed between 2005 and 2014. That report came after now-infamous Turing Pharmaceuticals CEO Martin Shrekli announced that his company would raise the price of generic drug Daraprim, which is used to treat toxoplasmosis, from $13.50 to $750 a pill. Shrekli has since been arrested for securities fraud.
Several lawmakers, including Alexander and Hatch, said the FDA needed more support to further the generic drug approval process.
“If our goal is to make sure patients have access to and can afford the safest and most effective courses of treatment we have to look at the research we're putting into this effort,” Alexander said. "If you want the FDA to approve drugs more quickly without rolling back the gold standard of consumer safety and protection, the FDA is going to need more support to do its job."
