FDA Releases New Data to Help Generic Drug Competitors

Regulatory NewsRegulatory News | 18 June 2019 |  By 

Generic drug applicants will now have more information from the US Food and Drug Administration (FDA) when deciding whether to file a generic drug application, which could potentially increase the odds of earlier approvals, the agency said on Tuesday.

Previously, FDA’s Paragraph IV Patent Certifications List included only the name of the drug (along with the dosage form and strength) and the date on which the first substantially complete generic drug application that contained a Paragraph IV certification was submitted to the agency. But potential generic applicants may not have been certain on whether an application previously submitted to FDA might be eligible for 180-day exclusivity.  

Now, the Paragraph IV Patent Certifications List will include several new data points, including the status of any 180-day exclusivity decisions for individual drugs, along with other information about the dates of first approval, marketing status and expiration dates of blocking patents.

“This data may also provide more public transparency into instances in which the FDA approves an ANDA with exclusivity, but the generic product is not marketed for an extended time which among other reasons may signal ‘gaming’ tactics in the generic market,” FDA said. “In addition, we’re sharing the number of applicants that are potentially eligible for 180-day exclusivity. This information may inform other generic manufacturers’ decisions on whether to develop a generic drug for that product. These new data fields will be included for any drug products that are the subject of ANDAs [abbreviated new drug applications] with Paragraph IV patent certifications, beginning today.” 

Michael Carrier, distinguished professor of law at Rutgers Law School, told Focus via email: “This shows the FDA’s increasing attention on competition issues. I think this could increase the number of ANDAs filed. Certain generics will rush to be the first filer (for example after the FDA exclusivity period expires). But other late filers could be encouraged to enter if there are fewer first filers than they anticipated. In general, the 180-day period is so important that any new information would be helpful.”

The agency’s move to help generic competitors follows the US House of Representatives’ passage of a bill that aims to increase the utility of FDA’s Orange Book on generic drugs.

FDA also has been cracking down on companies attempting to delay generic competition (former FDA Commissioner Scott Gottlieb in 2017 famously called to “end the shenanigans”), with moves to publish a list of companies that may be restricting access to samples of their products to generic firms, publish a list of off-patent drugs with limited or no competition, and by prioritizing the review of generic drug applications for which there are fewer than three applications approved for the reference listed drug.

Additional FDA guidance on converting a final generic drug approval to a tentative approval is also coming soon.

“Related, though uncommon, sometimes a generic drug manufacturer previously granted final approval for a specific product may be court ordered to cease marketing due to patent infringement. To help ensure there’s a transparent process for how we handle post-approval patent infringement court orders and convert a final approval to a tentative approval, we intend to provide clarity to industry on how we handle this process in the near future,” FDA added.



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