Senator Jon Ossoff (D-GA) worked with Republicans and Democrats to pass the Increasing Transparency in Generic Drug Applications Act, increasing transparency in generic drug applications and reducing unnecessary delays for the delivery of low-cost medications.
In a statement, Sen. Ossoff explained how the bill will hold Big Pharma accountable and provide Georgians the alternatives they seek. To the Senator, this is purely a pro-consumer effort, and one that will reward Georgians enormously.
“Georgians deserve alternatives to expensive name-brand medications,” Sen. Ossoff commented. “This new law will help hold big pharma accountable and promote stronger competition for more affordable prescription drugs.”
The Bill
The bipartisan bill became law on February 3 as part of bipartisan government funding legislation. Its purpose is to streamline the drug review process of generic drug applicants by establishing new requirements for the Food and Drug Administration (FDA)
Specifically, the FDA will have to disclose to generic drug applicants what ingredients cause a drug to be different from and the same as brand-name drugs. By doing so, the bill will make generic drugs, which are lower-cost alternatives, more available to those in need.
Additionally, a person can submit a generic drug application and request to know if their drug is quantitatively and qualitatively the same as the brand-name version. If the FDA determines that the drugs are not the same, they must identify the ingredients causing the difference and their concentration.
To balance out this initiative, the bill places limits on the FDA to change the evaluation. For example, once the FDA determines that a drug is basically the same as the listed drug, the FDA cannot rescind that decision unless the health and safety of consumers is at risk.
The bill sets a strict deadline for the FDA to revise industry standards. Within one year of enactment, the FDA must publicize its standards, and the public must be given sixty days to provide comment.
Final guidance must then be published one year after the comment process, but the transparency guidelines take effect immediately upon enactment, regardless of finalized guidance.
