A ‘multi-faceted approach’: FDA’s actions to create generic competition

By Maggie Lynch

- Last updated on GMT

(Image: Getty/BankRX)
(Image: Getty/BankRX)

Related tags Fda fda commissioner Generic drugs Generics Regulations competition

US FDA takes aim at generic access by establishing new actions and maintaining its current regulations to increase competition in the generic market.

Ned Sharpless, the acting commissioner of the US Food and Drug Administration (FDA), made a statement addressing additional actions the agency is taking to increase generic competition​ and how the FDA is working toward its goal of providing greater access to generics​.

According to a spokesperson for the FDA, generic drugs account for about 90% of all prescription drug purchases in the US, and only 26% of overall spending on medications.

While the FDA does not have a direct role in drug pricing, it can take steps to increase competition in the market through the approval of generic drugs.

“Analyses have demonstrated that when three or more generics are approved and marketed, US patients have access to significantly more affordable generic drug products,” ​said the spokesperson.

The spokesperson added that studies have estimated that generic drugs have saved the health care system more than a trillion dollars over the past decade.

“A stated priority of the FDA is to undertake a multi-faceted effort to enhance drug competition. One way this can be achieved is by ensuring the public has generic options for their medications,”​ said the spokesperson.

The spokesperson also told us that under the Generic Drug User Fee Amendments (GDUFA) of 2012 (GDUFA), the generic drug approval process has significantly increased its efficiency and therefore supports access to safe and effective generic drugs.

Current actions

Sharpless’ recent statement addressed additional actions the agency is taking to increase this competition including the enhancement of the Paragraph IV Patent Certifications List, which is said to be the agency’s most viewed database for the pharmaceutical industry.

The list provides information about exclusivity related to generic challenges of patents on drug products.

Generic applicants can seek FDA approval to market a generic drug before the expiration of a patent for the corresponding brand name drug product through an application providing a statement that claims the patent is invalid or will not be infringed by the generic drug product that is being applied for. This statement, as part of an abbreviated new drug application (ANDA), is known as a ‘Paragraph IV certification’.

The agency also estimates that 843 ANDAs approved in 2017 were associated with a total yearly saving of $17bn (€14.95bn), compared to if these generics were not approved – due to the price reductions associated with increased generic competition. This includes the approvals of first-generics and approvals for generics entering markets with existing generic producers.

When a 180-day exclusivity of a product has expired or eligibility for exclusivity has been forfeited by the first generic drug applicant, other generic drugs that meet approval requirements may enter the market.

Several data points will be added to the Paragraph IV Patent Certifications List, and the status of any 180-day exclusivity decisions for individual drug products regarding approval, marketing status, and expiration dates of blocking patents.

Before the recent enhancement, the list included the name of the drug product, dosage, and the date on which the first complete generic drug application that contained a Paragraph IV certification was submitted.

By providing this additional information, the FDA believes that generic drug applicants will be able to determine when products can be approved and marketed much easier and be more informed regarding decisions about which generic drug applications are likely to be approved sooner.

Adding a layer of transparency

Transparency around generic approvals​ has been a point the FDA has been trying to further enforce with its movement to greater generic access.

“Transparency around the assessment process, and what drug products might be good candidates for development, can help support the availability of generics,”​ said the FDA spokesperson.

According to the FDA, the addition of the new data points will provide more public transparency into ANDA approvals that have exclusivity when the generic product is not marketed for an extended time. 

The spokesperson added, “Earlier and enhanced communication between FDA and industry over the course of the assessment also supports the development of generic drugs, including complex generic drug products, and should continue to help reduce overall time to approval for generic drug applications.”

Previous efforts to increase competitiveness in the generic market, and therefore provide greater access to generics, included increasing support for complex generic drug development and application review, prioritizing review of specific generics, and publishing a list of off-patent, off-exclusivity brand drugs.

The agency is now focused on reducing approval times to increase the efficiency of the generic drug application submission process.

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