WASHINGTON – U.S. Senators Bill Cassidy, M.D. (R-LA) and Tina Smith (D-MN) today introduced two bills, the Simplifying the Generic Drug Application Process Act and the Modernizing Therapeutic Equivalence Rating Determination Act, to speed the development of and improve access to lower-cost generic drugs. These bills make changes to the Food Drug and Cosmetic Act (FDCA) and 505(b)(2) approval pathway, which will make it easier for generics to come to market driving up competition and driving down drug prices.
“Being able to afford medicines is key to healing sickness. This bill makes medicines more affordable which cares for a patient’s pocketbook and her health,” said Dr. Cassidy.
“Patients should be able to afford the medication they need, yet nearly 3 in 10 Americans report that they did not fill a prescription because it was too expensive,” said Senator Smith. “My bipartisan bills with Sen. Cassidy will help make prescription drugs more affordable and accessible by bringing more generics to market.”
The Simplifying the Generic Drug Application Process Act repeals section 505(j)(2)(C) of the Food Drug and Cosmetic Act (FDCA) so that sponsors can submit generic drug applications (ANDAs) without the need for the U.S. Food and Drug Administration (FDA) to first grant a suitability petition. FDCA requires that if a generic drug sponsor wants to submit an ANDA for a drug that differs from the brand in terms of its route of administration, dosage form, or strength, then the generic needs to first submit a suitability petition to FDA requesting permission to file the ANDA. FDCA requires FDA to respond within 90 days, but if FDA does not respond, the generic cannot file the ANDA. Unfortunately, FDA has not responded to many suitability petitions filed over the last seven years – preventing submission of ANDAs for drugs in shortage and drugs without generic competition. This bill repeals the requirement to file a suitability petition for ANDAs that do not require clinical data. Even with this change, FDA still has the opportunity to review the proposed change to the brand before the ANDA is filed and then again when reviewing safety and efficacy as part of the review process.
The Modernizing Therapeutic Equivalence Rating Determination Act requires FDA to assign therapeutic equivalence ratings for 505(b)(2) applications at the applicant’s request, as it does for ANDAs. The 505(b)(2) approval pathway is used to approve new drugs while leveraging certain data from an already approved drug. To the extent that the drug candidate differs from the already approved drug, the sponsor has to generate sufficient data including clinical data to support the differences, but does not automatically receive a therapeutic equivalence rating. A therapeutic equivalence rating is necessary to trigger automatic substitution at the pharmacy level and thus critical to driving competition. Because 505(b)(2) is technically a new drug pathway, the statute does not require FDA to assign a therapeutic equivalence rating. Sponsors can request it via the citizen petition process, but this can take significant time. Requiring FDA to assign a therapeutic equivalence rating for 505(b)(2) applications will level the playing field for 505(b)(2) products to compete with name brand drugs.