Bill would streamline FDA approval process for generic drugs
WASHINGTON – U.S. Senators John Hickenlooper, Maggie Hassan, Rand Paul, and Mike Lee reintroduced the bipartisan Increasing Transparency in Generic Drug Applications Act to lower prescription drug prices for patients by streamlining the approval process for generic drugs to enter the market more quickly. Last Congress, Hickenlooper voted the bill out of the Senate Committee on Health, Education, Labor, and Pensions (HELP).
“More generic drugs means lower health care costs for Americans. Unnecessary and unclear FDA approval processes delay them from reaching the shelves,” said Hickenlooper. “Our bill speeds up the process to help Americans save more.”
“Skyrocketing prescription drug prices are forcing too many Granite Staters to choose between their health and their financial security,” said Hassan. “This commonsense, bipartisan legislation will help address a critical obstacle in the generic drug approval process that keeps affordable alternatives off of pharmacy shelves. By requiring more transparency from the FDA and streamlining the drug approval process, this bill will help deliver lower-cost medications to Americans faster.”
“No one should have to play a complicated guessing game with the FDA simply to bring a safe, effective, and affordable drug to market. The Increasing Transparency in Generic Drug Applications Act will help low-cost generics get to American consumers faster,” said Paul.
“Generic drugs have made the prescription drug market much more competitive, offering cheaper alternatives to their brand name counterparts. Streamlining the generic drug approval process by eliminating the pointless guessing game manufacturers are forced to play would eliminate red tape and bring down costs for American families,” said Lee.
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. 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.
“S. 1302 expedites generic submission by creating process efficiencies for FDA and Industry. These efficiencies will enhance patient access to lower-cost medicine. When generic medicines become available, they bring immediately lower prices for lifesaving and life changing medications. We are thankful for the work done thus far by Senators Hassan, Paul, Hickenlooper, and Lee,” said John Murphy, III, President & CEO for the Association for Accessible Medicines.
Full text of the bill is available HERE.
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