FDA Approves First Generic Drug Version of Daraprim

March 09, 2020 - Patients will now have access to a cheaper version of the drug at the center of a recent price gouging case. In an announcement on Feb. 28, the FDA reported that it has approved the first generic drug version of Daraprim, which is used to treat toxoplasmosis.

This approval expands the agency’s commitment to increasing competition in the markets with limited or no generic alternatives.

“Through the FDA’s Drug Competition Action Plan, we’ve worked to remove barriers in generic drug development by not only taking actions that improve the efficiency of the development, review the approval of generic drugs, but also by closing loopholes that allow brand-name drug companies to ‘game’ the rules in ways that delay generic competition that Congress intended,” FDA Commissioner Stephen M. Hahn, MD said in the announcement.

Toxoplasmosis is an infection caused by a single-celled parasite called Toxoplasma gondii that may cause damage to the brain, eyes, or other organs. An individual may contract this infection by eating undercooked meat or shellfish, drinking water contaminated with Toxoplasma, or accidental swallowing of the parasite.

Toxoplasmosis is considered the leading death of foodborne illness in the US, yet only about 11 percent of the population six years or old have been affected, according to statistics from the CDC.

The drug used to treat the condition was recently the subject of a case involving Turing Pharmaceuticals, founded by Martin Shkreli.

In 2015, Turing Pharmaceuticals acquired Daraprim and immediately raised the price from $13.50 per tablet to $750. Some patients saw their annual cost for the drug increase to hundreds of thousands of dollars.

Shkreli, founder and chief executive of Turing Pharmaceuticals, found himself in hot water after the increase. He believed the drug was so rarely needed that the impact on the health system would be non-existent. 

“This isn’t the greedy drug company trying to gouge patients, it is us trying to stay in business. This is still one of the smallest pharmaceutical products in the world,” Shkreli said at the time. 

Shkreli was later imprisoned for crimes unrelated to the price setting controversy, but Turing Pharmaceuticals (now known as Phoenixus) maintained a monopoly on Daraprim even though the drop lost its patent protection.

The FDA’s approval will usher in a new player. Pharmaceutical company Cerovene is the sponsor of the new generic version of the drug. The FDA did not release how much the company plans to charge for the generic drug or when it will be released.

However, the agency did highlight in the announcement how this approval is part of its efforts to stop pharmaceutical companies like Turing Pharmaceuticals from maintaining monopolies on off-patent drugs.

Since 2017, the FDA has attempted to address the challenges in developing generic drugs in its Drug Competition Action Plan by improving the efficiency, review, and process of the development, as well as closing loopholes that allow brand-name drug companies to delay the generic competition.

Generic drugs that have less than three approved generic versions or don’t have any blocking patents or exclusivities are prioritized on the FDA’s list of submissions. 

The FDA prevents any generic competition from obtaining samples of certain medicines using certain “gaming” tactics, according to the announcement. One tactic is to improve transparency about this issue by posting a list identifying all drugs that the FDA received an inquiry related to “limited distribution of the reference drug from a prospective generic applicant.”

“Empowering patients and promoting choice and competition are top priorities for the FDA. These important efforts include improving access to safe, effective, and high-quality generic medications. Today’s approval is especially important for populations that are more susceptible to toxoplasmosis infections, such as pregnant women and individuals with HIV or AIDS by paving the way for more choices in treatment options,” Hahn concluded.