FDA Approves New Generic Drug Under Novel Pathway Aimed at Increasing Competition

The U.S. Food and Drug Administration approved a new generic potassium chloride oral solution under a novel term called the Competitive Generic Therapy designation. The new generic treatment, developed by Australia-based Apotex Inc., was approved to treat hypokalemia (low potassium blood levels) in patients who are on diuretics.

The FDA said the novel approval pathway was created to “expedite the development and review” of generic drugs that do not have any competition. The approval pathway could potentially close the door, or at least hinder, companies that significantly raise prices on a drug of which they are the sole manufacturer, like Turing Pharmaceuticals and the toxoplasmosis treatment Daraprim. After acquiring the nearly 70-year-old drug, the company raised the price by 5,000 percent. There were no other companies that manufactured the drug, so patients and payers were forced to pay the premium price for the medication.

FDA Commissioner Scott Gottlieb said the new Competitive Generic Therapy designation is designed to “encourage generic drug development for products with inadequate generic competition.” Gottlieb also noted that the new pathway was approved in its first cycle of review. He said that demonstrates the competitive generic therapy pathway is “efficient and open for business.”

“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. 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 in a statement. “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.”

This novel pathway isn’t the only method the FDA has explored that could open the doors to greater generic competition for narrow supply chain generic drugs. Last month the FDA said it was looking to address such threats by potentially importing foreign drugs under a narrow scope if conditions develop (such as massive price hikes) that block patient access to drugs.

Apotex Inc.’s generic potassium chloride oral solution was approved to treat hypokalemia in patients who are on diuretics, and when dietary management with potassium-rich foods is insufficient or diuretic dose reduction is not possible. Low potassium levels can lead to abnormal heart rhythms, especially in people with heart disease.

The new generic designation was able to be implemented under recent authorities provided to the agency in the FDA Reauthorization Act of 2017 (FDARA). Companies seeking approval under the new designation may receive review enhancements and expedited review of Abbreviated New Drug Applications, the FDA said. Additionally, applicants under this designation are also eligible for a 180-day period of marketing exclusivity if they are the first approved applicant for that CGT and meet certain other conditions, the FDA added.

The potassium chloride oral solution approved Wednesday is eligible for that 180-day period of exclusivity. The FDA said the applicant must commercially market the approved generic within 75 days of the regulatory approval or it will forfeit that exclusivity.