The “Increasing Transparency in Generic Drug Applications Act” (H.R. 1843), sponsored by Rep. Neal Dunn (R-FL) and Rep. Kevin Mullin (D-CA), would reverse a 2015 FDA policy change that has unnecessarily delayed the approval of some generic drugs.

Rep. Neal Dunn R-FL

“Americans deserve ample access to safe, generic medications,” said Rep. Neal Dunn. “Unfortunately, the FDA is slow to approve new generics. The Increasing Transparency in Generic Drug Applications Act would expedite and improve this process to save Americans money at the pharmacy counter.”

2015: FDA Creates Red Tape for Generic Medications

For complex generic medications, the FDA requires that both active and inactive ingredients be qualitatively and quantitatively identical to the brand-name reference drug – a standard known as “Q1/Q2 sameness.”

Prior to 2015, when the FDA determined that a proposed generic drug didn’t meet these requirements, the agency would tell manufacturers specifically which ingredients were problematic and whether the amounts were too high or too low. This feedback allowed companies to quickly reformulate and resubmit their applications.

In 2015, the FDA abruptly changed course without notice. The agency now only informs companies that their formulation doesn’t match the reference drug, without specifying which ingredients are at issue or how they deviate.

The policy change has created what amounts to a guessing game for generic manufacturers, forcing them to conduct expensive trial-and-error reformulations that can take years to resolve.

“A decade ago, the FDA created new bureacratic hurdles that slow down the approval process for generic medications,” explains Terry Wilcox, the co-founder and Chief Mission Officer at Patients Rising. “This legislation will end nearly a decade of unnecessary bureaucratic delays that have kept generic medications out of patients’ hands.”

H.R. 1843 seeks to re-establish the FDA’s prior policies by requiring the agency to:

• Disclose the specific ingredient(s) that cause the generic product to not be Q1/Q2 the same as the reference listed drug (RLD).
• Provide the amount of any identified deviation.
• Issue guidance on its Q1/Q2 assessment criteria.
• Allow for public notice and comment before implementing future policy changes.

Generic Drugs Save Patients Billions of Dollars

Generic drugs are typicall less expensive than their brand name equivalents. Generic medications saved Americans $373 billion in 2021, according to a report by the Association for Accessible Medicines (AAM). 

A coalition of more than two dozen patient advocates, consumer groups, and taxpayer watchdogs backed similar legislation in 2022.

“Striking the right balance between innovation and access is the hallmark of our drug approval system,” argued 26 patient advocacy and consumer organizations, including Patients Rising, National Psoriasis Foundation, and the Colon Cancer Coalition. “Getting affordable medicines to market in an efficient, streamlined manner helps maintain that balance and ultimately will result in lower drug prices for Americans.”