April 30, 2012 – Comments are due May 7 on an FDA-proposed paradigm that would allow the agency to approve

certain drugs – that would otherwise require a prescription – for over-the-counter (OTC) distribution under “conditions of safe use.”

An FDA statement regarding expansion of the definition of nonprescription drugs says that the agency believes that some doctor visits can be eliminated under the new paradigm to remove cost or time barriers that may deter consumers from receiving appropriate medications.

“We applaud the FDA for jump-starting a public conversation about how to get medicines into the hands of people who need them with adequate directions for safe and effective use,” said Coalition for Healthcare Communication Executive Director John Kamp. “Public and targeted communication will be key to success. The stakes are high because success here means better health for individuals and better public health outcomes.”

According to Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, OTC drugs have had great success in providing consumers with excellent self-care options. “But our concept of self-care is limited to conditions that can be self-diagnosed and self-treated based on the information in the drug facts box, combined with common knowledge. What we are asking is, should there be more flexibility in the concept of nonprescription drugs? Can we broaden the assistance a consumer gets and increase the types of medicines that might be available over-the-counter?”

The new paradigm would ensure safe and appropriate use by applying special conditions to types of nonprescription products. “For example, before getting a medication, you might have to talk with a pharmacist, or need to have a diagnostic test,” the FDA states. “In other cases, you might have to visit a physician to obtain the original prescription, but not to get refills. FDA is also considering whether some drugs could be a prescription drug and a nonprescription drug with conditions of safe use.”

Among many questions cited in a call for comment published in the Feb. 28 Federal Register, the agency has requested input on the feasibility of this initiative, and what types of evidence would be needed to demonstrate that certain drugs could be used safely and effectively in an OTC setting. The agency also has requested input on dual availability of drugs by prescription and OTC and whether diagnostic tests would need to validated for a change in setting, such as in a pharmacy.

The agency lists a number of potential benefits for consumers from this initiative: an increase in the appropriate use of medication, decreases in health costs, greater access to health screening, easier access to needed medications, and better, more consistent treatment of common conditions. Major challenges with the proposed paradigm shift include reworking FDA rules and separating patients from appropriate medical care. Other potential challenges are: liability concerns, disruption of workflow for often overburdened pharmacists, equipment costs, and questions about health insurance reimbursement.

Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest, said on DrugWonks.com that some questions still remain regarding this proposal, such as: “How will this impact patient compliance?  How will this affect one condition masking another, more serious one? How will this change the role of the pharmacist?”

“Hopefully stakeholders will share their views on this proposal so the FDA has the information it needs to consider this option,” Kamp said. “Regardless of the outcome here, FDA is to be commended for thinking outside of the box.”