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FDA Launches Streamlined Generic Drug Approval Process

By John Commins  
   August 08, 2018

The Competitive Generic Therapy designation looks to encourage the development of alternatives for drugs with inadequate generic competition.

The Food and Drug Administration on Wednesday approved a potassium chloride oral solution as the first generic drug to receive a streamlined Competitive Generic Therapy designation.

The new approval process expedites the development and review of generic alternatives for products that lack competition, FDA said in a media release.

"Today's approval marks the successful implementation of a new program designed to encourage generic drug development for products with inadequate generic competition," said FDA Commissioner Scott Gottlieb, MD.

"The quick implementation of this new pathway is part of our broader effort to foster generic competition and help address the high cost of drugs," Gottlieb said. "So are our efforts to narrow the time it takes for generic drugs to reach the market by reducing the number of review cycles that generic applications typically undergo."

Gottlieb said the new generic drug was approved in its first review cycle.

"This approval demonstrates that the competitive generic therapy pathway is efficient and open for business," he said. "This pathway is a key step in making safe and effective generic drugs available to patients quickly and ensuring there’s adequate competition so patients have affordable access to the treatments they need."

Potassium chloride is an oral treatment for low potassium blood levels in patients who are on diuretics.

The FDA Reauthorization Act of 2017 can designate drugs as a Competitive Generic Therapy if there is not more than one approved drug in the active section of the Orange Book.

CGT-designated drugs are eligible for an expedited review and receive a 180-day exclusive marketing period if they are the first approved applicant for that CGT designation. 

The FDA granted approval of the potassium chloride oral solution USP to Apotex Inc.

Association for Accessible Medicines President and CEO Chip Davis credited the FDA "for recognizing the critical role generics play in helping to control overall drug costs."

"Generic manufacturers have responded to the Administration's efforts to increase competition through the new CGT pathway and remain committed to working to ensure that safe, effective and more affordable FDA-approved generics are accessible to patients and providers," Davis said. "This pathway, created through FDARA, is a better long-term sustainable solution than considering bringing in drugs from foreign markets."

PhRMA said it "applauds the FDA's use of its new authority to designate and approve a competitive generic therapy where there is inadequate competition and no remaining patents or exclusivity."

Premier, Inc. Senior Vice President Blair Childs said that the FDA's actions on Wednesday "enhance access to affordable treatments for patients with low potassium blood levels."

"On a larger scale, FDA's use of this new expedited process will create competitive friction for single-source generic drugs to foster market forces, which can help drive down prices," Childs said.

John Commins is a senior editor at HealthLeaders.


The new pathway is part of a broader FDA effort to foster generic competition and address drug costs.

The streamlined process expedites development of generic alternatives for products that lack competition

Certain designated generic drugs can receive a 180-day exclusive marketing period.

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