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FDA Approves Cocaine Nasal Spray as Study Casts Doubt on FDA Standards
The FDA Allows a Cocaine Nasal Spray to Enter the Medical Market
On January 13, the pharmaceutical company Lannett Company, Inc. announced that the United States Food and Drug Administration (FDA) approved its New Drug Application to market Numbrino, the brand-name for a cocaine hydrochloride nasal spray. Numbrino is a topical solution for the mucus membranes in the nasal cavities. Lannett Company intends to advertise and sell Numbrino to otolaryngologists, a group of doctors who specialize in the ears, nose, and throat. Otolaryngologists who buy Numbrino will use the drug as a local anesthetic during nasal operations. The drug will not be available for ordinary retail.
Numbrino is the first brand-name medication ever to be sold by Lannett Company, a Philadelphia-based manufacturer of about 100 generic drugs. The announcement caused the value of Lannett Company shares to rise by 5.7%. Tim Crew, the company’s CEO, hailed the FDA’s decision as “a major milestone in Lannett’s 70-plus years of operations” and predicted a product launch for Numbrino would happen soon. Last year, Lannett Company received FDA approval to sell a generic version of Adderall, a popular medication for ADHD.
Cocaine in Medicine and the FDA
Cocaine is a Schedule II controlled substance, a drug with medical value which poses serious risks for abuse and addiction, according to the federal government. Although it is illegal as a recreational drug, cocaine is legal as an ingredient in legitimate medications.
In fact, Lannett Company is not the first business to manufacture an anesthetic with cocaine. In 2019, Lannett Company won a regulatory battle against Genus Lifescience, a competitor also headquartered in Pennsylvania, over the latter company’s claim to a five-year period of exclusivity for its own cocaine hydrochloride product the FDA approved two years earlier. The FDA dismissed a petition to uphold an exclusivity period and allowed Lannett Company to submit Numbrino for approval.
The FDA Takes Less Time to Approve Drugs
Since 1906, the FDA has been responsible for assessing the safety and effectiveness of drugs before allowing pharmaceutical companies to sell them to Americans. The agency must consult clinical trials to ensure the benefits of every drug outweigh the risks. The FDA approved Numbrino only after the drug underwent a “phase 1” and a “phase 3” clinical trial. A phase 1 clinical trial takes several months and requires 20 to 100 subjects to test the short-term safety of a drug. A phase 3 clinical trial involves as many as 3,000 subjects and takes several years to monitor a drug’s long-term effects and hazards.
A study published this month in the Journal of the American Medical Association (JAMA) found the FDA is approving drugs faster than ever before. The researchers for the study determined the FDA approved an average of 41 drugs every year from 2010 to 2018. By contrast, the agency approved an average of 34 drugs every year from 1990 to 1999.
While the number of approvals has increased, the length of time the FDA dedicates to reviewing New Drug Applications has decreased. Specifically, the median length of time the FDA spent on reviewing data on a given drug from 1993 to 2005 was 1.5 years. From 2006 to 2017, the median length of time for review fell to 1.2 years. In 2018, the median length of time fell even further to just eight months. According to the study, accelerated review for drugs at the FDA “reduc[es] the amount of evidence available at the time of approval and increas[es] uncertainty about the existence or amount of clinical benefit.” Nevertheless, drug companies still take about seven years to conduct clinical trials, as they did thirty years ago.
The Pharmaceutical Industry Pays the FDA “User Fees” to Expedite Approval
The study attributes this trend to laws that Congress passed in the 1980s and 1990s to accelerate drug approval for HIV/AIDS and other diseases for which medications were not available. One law, the Prescription Drug User Fee Act of 1992, allows drug companies to donate money to the FDA to help the agency hire more researchers and review drugs more quickly.
In 2018, drug companies paid over $900 million to the FDA for this purpose. The JAMA study estimates that about 80% of the salaries of FDA researchers depend on Big Pharma “user fees.” The intention of the Prescription Drug User Fee Act was to create a partnership between the drug industry and the FDA for the benefit of patients, but researcher Jonathan Darrow suggested the law “has created a culture in the FDA where the primary client is no longer viewed as the patient, but as the industry.” Darrow and his peers say Congress should consider revisions to the system.