The Food and Drug Administration has started to move generic drug applications to the front of the line if they compete with high-priced products.
Sens. Susan Collins, R-Maine, and Claire McCaskill, D-Mo., filed legislation in March calling for the agency to change the way it prioritizes generic drug applications. The agency has since told the senators, who lead the Senate Special Committee on Aging, that they are able to do it without legislation.
“The FDA is starting to change its manual on how it handles the processing of applications for approval of generic drugs that compete with monopoly drugs,” Collins told the Washington Examiner recently.
The agency has methods to advance the approval process for drugs that address an unmet medical need but does not factor pricing into such decisions.
The move addresses an issue that has received much public scrutiny. Some drug companies have bought the rights to older generic drugs that have been on the market for decades and then jack up the price.
The generics often don’t have any competition since they aren’t prescribed to a lot of patients and the process to get a generic drug approved by the FDA can take more than a year.
For example, the small biotech firm Turing Pharmaceuticals ignited an outcry after it bought the rights to anti-malarial drug Daraprim in August 2015 and raised the price overnight from $13.50 a pill to $750. Daraprim has been on the market since the 1960s and has no competition.
Valeant, another company that raised the price of several generics, testified before the Senate aging committee on Wednesday and apologized for the practice.
The move by the FDA essentially would move a generic drug to the front of the line if it competes with a Daraprim or similar product, McCaskill told the Examiner. The agency has a backlog of more than 3,000 generic drug applications.
Even with the speedup, it could still take more than a year for the drug to get approved and on the market.
Lawmakers have criticized the agency’s generic approval process for being too slow to address the lack of competition needed to drive down prices. FDA officials have previously told Congress that it is making progress on approval times.
In 2012, the agency established a user fee program in which generic drug makers pay the agency every time they submit an application. Those funds must be used to reduce the approval timeline for generics partly through hiring more staff.
The FDA hopes to get the review time for a generic drug down to 10 months by 2017.
Meanwhile, the Senate aging committee is drafting more legislative proposals to address high drug prices. It is not clear what the legislation will focus on, and McCaskill shied away from saying whether the panel will write a bill that caps prices on drugs.
“I think that we want to gather all the information and look at everything,” she said. Collins said she hopes to get legislation approved by the end of the year.
“That may be very hard given how much we are going to be out because of the conventions, but I think this is really important,” she said.
