Bill would streamline approval process for generic drugs
WASHINGTON – U.S. Senators John Hickenlooper, Maggie Hassan, Rand Paul, and Mike Braun’s bill to get generic drugs to market more quickly, and lower the cost of prescription drugs, recently passed out of the Senate Committee on Health, Education, Labor, and Pensions (HELP). The Increasing Transparency in Generic Drug Applications Act will now head to the Senate floor for a final vote.
“Expanding generic drugs in the market will lower everyone’s prescription costs,” said Hickenlooper. “This bill will improve the generic approval process so that cheaper medications are more available to Americans.”
Current FDA policy requires certain generic drug manufacturers to demonstrate that their medication has the same levels of active and inactive ingredients as a brand name drug. But if the generic drug contains the wrong amount of inactive ingredient, the FDA is not allowed to disclose how the generic comes up short. As a result, manufacturers end up playing a time-consuming guessing game until they reach the right formula. This legislation would require the FDA to clearly identify the formulaic differences between a generic and brand name drug to streamline the approval process.
Hickenlooper’s bill passed in the HELP Committee as an amendment to the Expanding Access to Low-Cost Generics Act, a larger piece of legislation that aims to increase generic drug competition, and bring generic drugs to market more quickly. During the same session, Hickenlooper also voted to advance legislation to regulate Pharmacy Benefit Managers (PBMs) by increasing transparency and requiring PBMs to pass 100% of rebates and discounts on to customers.
Senator Hickenlooper sits on the Senate Health, Education, Labor, and Pensions committee which is leading the effort to make prescription drugs more affordable.
Full text of the bill is available HERE.