FDA Launches Effort to Improve Transparency for Drug Applicants

Pharmacy TimesAugust 2019 Back to School
Volume 85
Issue 8

The agency aims to increase timely access to high-quality, lower-cost generic drugs.

The FDA, in a bid to improve predictability and transparency for generic drug applicants, outlined its efforts in a recent statement. In 2017, 90% of prescriptions in the United States were filled with generic drugs, and the FDA approved or tentatively approved more than 2000 generic drug applications in 2017 and 2018, according to a statement from Acting Commissioner of Food and Drugs Norman E. Sharpless, MD.

The FDA previously implemented steps supporting drug development, prioritizing the review of some generic drugs, and publishing a list of off-exclusivity, off-patent brand drugs, all in an effort to increase the competitiveness of the generic-drug market. FDA data have shown that prices decrease significantly when at least 3 generic versions of a drug are on the market.

As part of the Drug Competition Action Plan, the FDA said it intends to publish additional guidelines and take further policy steps to improve the process for drug applicants.

“Each of these efforts [was] aimed at getting more competitors into the market, which might drive down prices for consumers, all the while making sure generics meet the FDA’s approval standards and will be manufactured under our rigorous quality standards,” according to an FDA statement.

Now, however, the FDA is turning to internal policies to improve the application process, and availability of resources to generic-drug applicants is one part of its new effort. By ensuring that applicants have a clear idea of the timeline and status of their application, the agency said it will be able to provide patients with timelier access to high-quality medications at lower price points.

“We are working hard to reduce approval times and to enhance the efficiency of certain aspects of the submission process for generic drug applicants,” the statement said. “We are also striving to provide the industry with greater transparency in order to provide greater certainty around timing of market entry and empower more informed decisions on how to prioritize their resources.”

To that end, the FDA has introduced enhancements to the Paragraph IV Patent Certifications List, which provides information on 180-day exclusivity. If a generic applicant provides a statement arguing the brand name’s patent is invalid or unenforceable or will not be infringed by their generic product, they may seek FDA approval to market the product before the original patent’s expiration. This statement, included in the abbreviated new drug application (ANDA), is the “Paragraph IV certification.”

The FDA added several new data points to the Paragraph IV Patent Certifications List, including the status of any 180-exclusivity decisions, the dates of first approval, marketing status, and expiration dates of blocking patents. Before these additions, the list included the name of the drug and the date of the first substantially complete generic-drug application that contained a Paragraph IV certification.

The update will help potential applicants understand which applications are more likely to be approved and when that approval could be finalized. The new data points could also provide more public transparency in situations in which the FDA grants an ANDA with exclusivity but the generic version is not marketed for an extended period.

The FDA will also begin releasing the number of applicants with potential eligibility for 180-day exclusivity, to help inform other generic manufacturers’ development decisions. Finally, to ensure transparency on how to handle postapproval patent infringement court orders, the FDA said, it intends to improve clarity on how to handle the legal proceedings.

“Drug access is a public health concern, and more generic competition could help reduce prices, improve access to needed medicines, and benefit the public health,” according to the statement.


Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs [news release]. Silver Spring, MD: FDA; June 18, 2019. www.fda.gov/news-events/press-announcements/statement-new-effort-improve-transparency-and-predictability-generic-drug-applicants-help-increase. Accessed June 19, 2019.

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