The Food and Drug Administration is considering a big change that would make more drugs available over the counter. Done carefully, it would be a move in the right direction. The agency, wisely, wants greater flexibility to take advantage of information technology and the expertise of pharmacists to improve the public's access to medicines.
Legal drugs essentially fall into two categories: prescription or over-the-counter. The rule for those available over the counter is that the "fact box" on the package must provide all the information consumers need to self-diagnose and select the proper medication. But that's an antiquated restriction in the modern, information-rich world.
Consumers today tap a variety of sources for knowledge about medicines, including websites and pharmacists. The FDA wants the regulatory flexibility it needs to incorporate that reality when evaluating whether to approve the nonprescription sale of a drug that currently requires a prescription.
While safety concerns must be carefully assessed, this kind of out-of-the-fact-box thinking generally is the right approach, using technology to better deliver medical care and contain costs. Fewer doctor and emergency room visits aren't the FDA's objective, but that money-saving outcome should be one result of the proposed changes.
Freed from the confines of the fact box, regulators could make some drugs easier to get while imposing conditions for safe use. For instance, consultation with a pharmacist could be required before purchase. Or a computer kiosk could be mandated at the point of sale to provide additional information. Or the computer could present a checklist -- age, gender, medical history, blood pressure, etc. -- to help consumers select the right medicine.
The idea is still more concept than detailed proposal. It was aired in public hearings in March and a public comment period that ended last week. There should be more expert and public input before deciding how to modify this long-accepted standard.
Can computers or videos or checklists effectively guide consumers in this complex arena? Will pharmacists embrace an expanded role? Who will be liable for damages if things go wrong? And the most critical question of all: Will this approach be safe? The American Medical Association is concerned that anything that means fewer office visits would compromise patient care.
The FDA is a long way from a final decision and should proceed deliberately. But the public shouldn't cling to old ways simply because that's how they've always been done. Historically, pharmacists weren't allowed to give vaccinations. Now they can, a change that has occurred state by state in the last decade. More than 175,000 pharmacists nationally have completed the required training. And in the last flu season they vaccinated more than 20 million people -- no doubt including some who would not have seen a doctor for the shot.
More flexible regulation that safely expands access to care is a goal worth pursuing.