FDA has clarified several misconceptions stated in comments by stakeholders about a potential new paradigm for evaluating Rx-to-OTC switches “under conditions of safe use,” including concerns that it would create a new class of drugs.

Rikin Mehta, an official with the Office of Medical Policy Initiatives in FDA’s Center for Drug Evaluation and Research, discussed the paradigm, which FDA has named “NSURE” – the “nonprescription safe use regulatory extension” initiative – at the Regulatory Affairs Professional Society’s Regulatory Convergence conference in Seattle Oct. 28.

Mehta said “a lot of misconceptions came out of the public hearing” FDA conducted in March to discuss how innovative technologies and other conditions of safe use could expand the nonprescription drug market Also see "FDA To Tackle Critical Generics Issue In Switch Paradigm Debate" - Pink Sheet, 12 March, 2012.. Consumers, industry stakeholders and government officials spoke at the hearing and submitted comments.

“What we are doing here is looking at our nonprescription market and where we can create flexibilities in how we can consider drugs nonprescription through these conditions of safe use.” – FDA’s Rikin Mehta

One misconception voiced in comments is that NSURE would create a third class of drugs, such as a behind-the-counter class, said Mehta, deputy director of the Division of Medical Policy Programs in OMPI’s Office of Medical Policy.

“Drugs will remain either prescription or nonprescription. What we are doing here is looking at our nonprescription market and where we can create flexibilities in how we can consider drugs nonprescription through these conditions of safe use,” he said.

The misconception about a third class of drugs likely arose out of discussions about how in some cases pharmacists, prior to dispensing a switched product approved under conditions of safe use, might help consumers determine whether the drug is correct for them. In this scenario, the drug might be kept behind the counter so pharmacists can dispense it only when consumers meet certain criteria stated in the conditions of safe use Also see "Pharmacy Interests Back BTC Models For Third Class" - Pink Sheet, 18 June, 2012..

States Regulate Pharmacy Practices

A related question is whether NSURE would grant pharmacists authority to prescribe drugs.

“It is not so much that NSURE is giving pharmacists prescribing power,” but asking how pharmacists can help consumers accurately self-select nonprescription drugs, Mehta said.

“How will it look? That is what we are developing and we will receive feedback on how the program will develop.”

Mehta pointed out that pharmacy practices are regulated by states, not by FDA. “Licensing authority over the practice of medicine by pharmacists and other health professionals, including prescriptive authority, is granted and controlled by the states,” he said.

Mehta also noted that the intention of NSURE is not to move every prescription drug to OTC status eventually, as some commenters suspected.

“The approval of a drug product as nonprescription with a condition of safe use is product-specific and it is intended to undergo FDA’s rigorous process which will test the safety and efficacy of individual product,” he said.

NSURE Not Aimed To Threaten Doctor Visits

Also among the misconceptions is the idea that NSURE “will reduce or eliminate doctors’ visits” because patients will be able to buy more treatments without a prescription under the initiative, he said.

At the hearing in March, a representative from the American Medical Association voiced concern that expanded access could weaken patients’ relationships with physicians ([A#05120326012]).

However, Mehta said the program is aimed at reintroducing patients to the health care system who may have fallen through the cracks because they cannot afford to fill their prescriptions or visit a doctor. “The intent of the program is to reach those who are not currently seeing a health care provider.”

In the Federal Register notice announcing the March public hearing on novel switches, FDA discussed the public health need for making more drugs available. “Under-treatment of many common diseases or conditions … is a well-recognized public health problem. Increasing the number of people who are able to obtain for the first time and those who continue on necessary drug therapy could provide improved health outcomes,” FDA stated ([A#05120227016]).

A related concern that surfaced in comments to FDA is that patients who skip visiting the doctor and head straight for a drug store will incorrectly select drug products, Mehta said.

While that may happen, he said the “condition of safe use would be tested to help patients self-select products correctly. So again, there is going to be a regulatory approval system for this. It is not going to be overnight where all of a sudden anyone can throw a condition of safe use on their product and start marketing it over the counter.”

Mehta said FDA recognizes that clarifying misconceptions about NSURE to the public and health care industry will not be accomplished overnight, but it is one of the agency’s main focuses currently with regard to the initiative. FDA continues to solicit and explore feedback from the public and stakeholders to help shape policy decisions about the initiative going forward.

“This is a concept that is in development,” Mehta said.

FDA Aims To “NSURE” Clarity About New Paradigm For OTC Switches

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