A novel solution to address the soaring prices of generic drugs would approve competitors about seven times faster than normal, but some say that may not be enough to deal with the issue.
During the first Senate hearing on high drug prices last week, senators from both parties lauded a solution that would speed approval of certain generic drugs. The idea is to create more competition to combat companies that buy up older generic drugs and then raise the price.
The pathway would allow the Food and Drug Administration to approve a generic drug in about six months, much faster than the drug industry’s current estimate of 48 months.
Not all generic drugs could use the pathway. The agency would allow only drugs that compete directly with pharmaceuticals whose prices have skyrocketed.
One key liberal group supported the idea, but didn’t want Congress to end there.
“As part of a broader reform it is a very good idea,” said Maura Calsyn, director of health policy for the think tank Center for American Progress.
The concern is that the pathway is aimed only at dealing with high-cost generic drugs and not with brand-name drugs whose prices also have increased.
“I don’t think it is a panacea and won’t solve a lot of other problems in the market,” she said.
The Campaign for Sustainable Rx Pricing, part of a coalition of insurers and business groups, was in favor of any measure that creates more competition in the generic drug market, but didn’t have a specific position on the pathway.
“We certainly think Congress should be giving more attention to price-gouging behavior,” said spokesman John Rother.
But the generic drug industry was more ambivalent about it.
“There is an existing framework for the agency to conduct priority generic drug application review,” said David Gaugh, senior vice president of sciences and regulatory affairs for the Generic Pharmaceutical Association, the industry’s main trade group.
The association said after the hearing last week that it wanted Congress to focus on other measures, namely a backlog of more than 3,000 generic drug applications.
It also wants Congress to repeal an increase in Medicaid rebates from generic drugmakers, which was inserted into the two-year debt limit deal.
The association also fervently disagrees with proposals from some lawmakers to allow importation of cheaper drugs from other countries such as Canada. GPhA said it is because the drugs don’t have the same quality standards as the FDA, but some imported drugs would be significantly cheaper than U.S. products.
Sen. Susan Collins, R-Maine, said last week after the hearing she would look into including a pathway in a larger FDA reform package next year.
The Senate hearing focused on companies that acquire decades-old treatments and raise the prices. Normally other generic companies don’t want to create a competitor because of the long FDA approval times and because the treatments often only have a small amount of prescriptions a year.
Take Daraprim, an old anti-parasite treatment prescribed to fewer than 10,000 Americans a year. The drug’s price was raised to $750 a pill from $13.50 this summer when the small biotech firm Turing Pharmaceuticals acquired it.
Under the pathway, an independent panel would look for a drug that experienced a similar price hike. The agency then would work to approve a competitor for that drug within six months, Dr. Gerard Anderson, professor at Johns Hopkins Bloomberg School of Public Health, said at the hearing last week.
The FDA already agreed to a series of reforms to the generic drug approval process as part of a 2012 law that allows the agency to collect user fees from manufacturers.
In exchange for the funding, the agency must meet certain approval timelines. For instance, by 2017 the agency has to approve 90 percent of its generic drug applications within 10 months.
