FDA Explores Options to Expand Access to Non-Rx Drugs

Manufacturers seek clear path to develop safe-use approaches for more risky OTC therapies.
May 02, 2012
Volume 36, Issue 5

Jill Wechsler
The prospect that consumers will improve their health through wider use of nonprescription drugs is back on the policy agenda at FDA. Pharmacists, healthcare companies, and some consumer groups are backing the agency's new campaign to authorize certain over-the-counter (OTC) drugs with special "conditions for safe use," such as access to electronic information and special assistance from pharmacists. Whereas OTC medicines primarily treat acute, short-term conditions, FDA officials are touting this "new paradigm" as a way to approve nonprescription meds for common chronic diseases, with the help of systems that assist patients in assessing their health and response to medication over longer terms.

FDA is considering whether "there should be more flexibility in the concept of nonprescription drugs," explained Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), during a two-day public hearing held in March by FDA to gain stakeholder input on the proposal. To approve an OTC therapy, FDA currently seeks evidence from manufacturers that the medicine can be used safely and appropriately based on the approved "drugs facts box" label and common knowledge. Now, FDA is exploring whether additional information from pharmacists and health IT systems could sufficiently augment consumer understanding of how to select and use a drug appropriately without going to a doctor.

Expanding authority

Such a change, Woodcock acknowledged, will require a lengthy rule-making process; legislation also is needed for FDA to permit simultaneous marketing of both prescription and nonprescription versions of the same drug. Manufacturers could implement "safe use" provisions voluntarily, but would be disadvantaged because FDA cannot compel competitors to adopt procedures not listed on the product label. There is talk of including authorizing language for this approach in this year's user-fee renewal legislation, but the desire to avoid any proposals that could delay Congressional action is likely to put the topic aside for the short term.

The rationale for expanded OTC drug access is that the cost and inconvenience of visiting a doctor to obtain a prescription deters many people from treating common health conditions—and from adherence to recommended therapy after treatment begins. There's strong evidence from the literature over the past 20 years that prescription-to-OTC switches for vaginal antifungals, allergy treatments, and heartburn medicines, among others, have promoted effective self-care. Testing innovative nonprescription products has improved methods for conducting label-comprehension studies and actual-use trials as well.

Yet, Merck failed several times to gain OTC status for its anticholesterol drug Mevacor (lovastatin), largely because FDA was not convinced that consumers could determine whether a cholesterol drug was right for them just by reading the product label. FDA has tried to handle with such situations by establishing a third category of "behind-the-counter" drugs available from pharmacists, as with the Plan B morning-after pill. However, manufacturers generally object to creating a third class of drugs or simultaneous marketing of a prescription and nonprescription product for fear that such options will confuse consumers.

Under FDA's new paradigm, manufacturers would ensure "safe use" of a medicine by using new IT programs and more home-use diagnostics to enhance and document individual understanding of appropriate drug use. Information kiosks and other IT aides in pharmacies, for example, could direct consumers through self-diagnosis information programs that check for risk factors contraindicating treatment and monitor continued safe use.

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