New Congressional Bill Aims to Reform Review, Approval Process

Pharmacy TimesMay 2022
Volume 88
Issue 5

Goal of modernizing therapeutic equivalence rating determination act is to increase availability, competition, drive down prescription costs.

A new congressional bill aims to increase drug availability and market competition and help drive down costs.1

In April, Reps Angie Craig, a Democrat from Minnesota, and John Curtis, a Republican from Utah, introduced the bipartisan Modernizing Therapeutic Equivalence Rating Determination Act to reform the FDA review and approval process for complex generic drugs.1

“Every year, millions of Americans all across the country struggle to fill prescriptions because they simply can’t afford the high prices of many name-brand drugs,” Craig said in a statement. “The United States must take immediate action to remedy this challenge by ensuring that generics are readily available for hardworking Americans, which will help to lower drug costs and create competition in the pharmaceutical industry.”1

The bill requires the FDA to assign therapeutic equivalence ratings for 505(b)(2) applications at the applicant’s request, which is similar to what the agency does with abbreviated new drug applications (ANDA).1

The 505(b)(2) approval pathway is used to approve new drugs by leveraging data from already-approved drugs. The sponsor must also generate sufficient data, including to support the differences of the drug compared with the already approved drug, but does not automatically receive a therapeutic equivalence rating.1

The therapeutic equivalence rating is necessary to trigger automatic substitution at the pharmacy level and is essential to driving competition.

However, because 505(b)(2) is a new drug pathway, the bill does not require the FDA to assign a therapeutic equivalence rating.1

A sponsor can request it via the citizen petition process, although this can take a significant amount of time. By requiring the FDA to assign a therapeutic equivalence rating for 505(b)(2) applications, the bill will help level the playing field for generic products to compete with brand-name drugs.1

“I hear frequently from Utahns about the challenges that high out-of-pocket costs create to accessing lifesaving prescription drugs,” Curtis said in the statement. “This bill helps to address this problem.”1

Meanwhile, companion legislation, the Simplifying the Generic Drug Application Process Act, has been introduced in the Senate.1

The bill repeals section 505(j)(2)(C) of the Food and Drug Cosmetic Act (FDCA) so that sponsors can submit an ANDA without the need for the FDA to first grant a suitability petition.2

The FDCA requires that if a generic drug sponsor wants to submit an ANDA for a drug that differs from the brand in dosage form, route of administration, or strength, the sponsor must first submit a suitability petition to the FDA.2

The petition requests permission to file the ANDA, and the FDCA requires the FDA to respond within 90 days. If the FDA does not respond, the generic sponsor cannot submit an ANDA.2

The FDA has not responded to many suitability petitions in the past 7 years, which prevents the submission of ANDAs for drugs that are on shortage and drugs without generic completion.2

The bill repeals the requirement to file a suitability petition for ANDAs that do not require clinical data.2

Under this change, the FDA can still review the proposed change to the brand before the ANDA is filed and then again when reviewing efficacy and safety as part of the review process.2

The bills both aim to amend the FDCA and 505(b)(2) approval pathways, thus making it easier for generic drugs to enter the market and driving the competition up and the prices down.2 Both bills were originally introduced in April 2021.


1. Curtis, Craig introduce bill to improve access to generic treatments. News release. Office of John Curtis. April 5, 2022. Accessed April 6, 2022. https:// -to-generic-treatments/

2. Cassidy, Smith introduce bills to lower drugs costs by speeding up devel- opment of and improving access to generics. News release. Office of Bill Cassidy. April 29, 2021. Accessed April 6, 2022. https://www.cassidy.senate. gov/newsroom/press-releases/cassidy-smith-introduce-bills-to-lower-drugs- costs-by-speeding-up-development-of-and-improving-access-to-generics

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