Pharma Seeks Relaxed FDA Oversight to Move Drugs to Over Counter

Drugmakers are urging the FDA to reassess the regulatory process of switching medications from prescription to over-the-counter, a rigorous procedure that must demonstrate a patient no longer needs a doctor’s supervision to access a treatment.

US Food and Drug Administration Commissioner Marty Makary has made clear he wants to make more drugs nonprescription in an effort to make medications accessible and reduce health-care costs.

Top manufacturers for nonprescription products including Tylenol-maker Kenvue Inc., Perrigo Co Plc, and Opella Healthcare Group SAS appear on board with the FDA’s initiative, but they’re asking the agency to cut the red tape in the regulatory process, according to comments shared with regulators this month.

The task is not only complex, costly, and lengthy, but also unpredictable, drugmakers said, requesting the agency provide more clarity and flexibility to meet Makary’s demand.

“It is as rigorous as a regular new drug application,” said Rachel Turow, a former regulatory counsel at the FDA, now an attorney at Skadden Arps Slate Meagher & Flom LLP representing industry. “FDA is going to have to be flexible if they want to aggressively switch things to OTC.”

Over 100 ingredients, indications, or dosage strengths have been approved through the agency’s switch process or received over-the-counter approval through a new drug application. Some pharmaceutical experts, however, say the number is relatively low considering the length of time since the first authorized swap that required a new application occured over 30 years ago. The latest switch approved was Harm Reduction Therapeutics’s opioid treatment RiVive in 2023.

Makary has authorized “substantial hiring” for nonprescription drug efforts to fill current vacancies and expand this initiative, Emily Hilliard, an agency spokesperson, said in an email. The FDA is encouraging drugmakers to develop nonprescription plans and request a meeting with regulators.

Still, switches are “much harder to do than he is letting on,” Turow said in an interview. “Even with the personnel changes, I think FDA is going to struggle with some of these categories of drugs that have strong warning language in the label to move them into the OTC realm.”

Cutting ‘Paternalistic Approach’

The process requires drugmakers to conduct and submit studies related to label comprehension, self-selection, and actual-use of a drug to demonstrate that consumers can use it without the supervision of a health-care provider. The FDA then determines if a drug remains safe and effective should it shift to nonprescription.

The process can result in programs getting mired in “very lengthy back and forth successive discussions” related to labeling formatting and language, which can add years to programs with existing over-the-counter categories, Kenvue said to the agency.

The company, which manufactures popular medications such as Benadryl and Zyrtec, said the FDA has taken an “overly paternalistic approach” and recommends it be more pragmatic in response to the studies submitted.

Perrigo, too, said switches “often fail” during the regulatory process due to the FDA’s concerns about patient behavior. The company suggests that data from labeling comprehension studies should be accepted as sufficient evidence to demonstrate consumers can self-select and use the product safely.

Opella, known for Allegra, IcyHot, and Dulcolax, asked for more certainty in the process, as there remains an ambiguity that can delay efforts to advance new nonprescription products.

“Drug sponsors need clearer expectations from the FDA,” David Spangler, senior vice president of legal, government affairs and policy for the Consumer Healthcare Products Association, said in an interview. “There’s definitely some friction as sponsors and FDA talk about what you absolutely need to have to show people can use it safely and appropriately.”

Companies are also urging the FDA to update guidance on the switch process as the agency hasn’t substantively amended its recommendations on label comprehension studies and self-selection studies in over a decade.

The agency issued a final rule in December 2023 related to nonprescription drugs, but that focused on a new pathway that allows medicines to be marketed with both a prescription and nonprescription status following certain guidelines.

The Pharmaceutical Research and Manufacturers of America, which represents some of the world’s largest drugmakers, said the FDA should implement the rule as a way to modernize the switch framework, rather than solely viewing it as a mechanism for approving nonprescription products.

“FDA has slowly loosened up a bit,” said Michael Hinckle, managing partner of K&L Gates LLP’s Research Triangle Park office. “There has been recognition that maybe we should let patients self-select and self-treat where it makes sense and where it’s safe.”

Suggested Switches

The agency also received feedback on which drugs should remain prescription or shift to over-the-counter.

Makary has repeatedly said that naloxone, commonly known under the brand name Narcan and used to treat opioid overdose, shouldn’t have a prescription. A nasal spray version is available over-the-counter, but higher doses and injectables still require a doctor’s oversight.

Various comments commonly suggested that treatments for anaphylaxis, erectile dysfunction, nausea, and menstrual pain should be nonprescription.

“I’ve also argued for GLP-1s,” Jeffrey A. Singer, a senior fellow of the Cato Institute, said in an interview. “It’s more controversial,” but studies are analyzing the drug’s potential to treat conditions beyond obesity and diabetes, he said.

Other comments suggested that medications for blood pressure management, flu and pneumonia, and migraines should remain behind the pharmacy counter.

“All drugs have a risk of side effects,” said Gina Moore, a senior associate dean at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences. “Aspirin has been over-the-counter and one of the drugs that’s been around forever, even Tylenol has a very rare hypersensitivity reaction associated with it.”

“It’s interesting,” Moore said. “If those drugs were introduced today, would they be approved for over-the-counter use?”