FDA Approves First Generic Under New Pathway for Boosting Drug Competition

The FDA has approved the first generic drug under its new pathway aimed at boosting drug competition through access to generics. The agency has greenlighted several strengths of potassium chloride oral solutions as the first generic drugs to receive a Competitive Generic Therapy (CGT) designation.

The oral solution is indicated for the treatment and prevention of hypokalemia—low potassium levels—in patients who are on diuretics, and when dietary management with potassium-rich foods is insufficient or diuretic dose reduction is not possible. As proper potassium levels are necessary for cells to function properly, low potassium levels are associated with abnormal heart rhythms, lightheadedness, fainting, and in extreme cases, heart failure paralysis or death.

Read more on the FDA Reauthorization Act of 2017.

The CGT designation, which allows generics to come to market faster, came as a result of the FDA Reauthorization Act of 2017. Under the Act, a drug can be designated as a CGT if there are no current generics available. Drugs that meet the CGT designation may receive review enhancements and expedited review of their Abbreviated New Drug Applications. They are also eligible for 180 days of marketing exclusivity if it is the first approved drug for that CGT and it meets other conditions.

“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,” said Gottlieb, in a statement, in response to today’s approval. “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.”

According to Gottlieb, this approval came in the first cycle of review. He added, "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."

Access to generics has been a key part of the administration’s efforts to tackle prescription drug prices. In President Donald Trump’s blueprint, announced in May, the administration, among other things, vowed to increase the number of generic and biosimilar options. The blueprint called for ending loopholes that allow manufacturers from blocking generic competitors to reach the market.

A week later, the FDA called out 39 pharmaceutical companies they said are delaying generic and biosimilar competition by blocking access to product samples generic manufacturers need to test its own version of the drug.

Since the release of the administration’s blueprint for lowering drug prices, HHS Secretary Alex Azar has appeared before the Senate Committee on Health, Education, Labor, and Pensions and the Senate Committee on Finance to reaffirm the administration’s committment toward increasing generic and biosimilar competition.