FDA To Consider ‘Over-the-Counter-Plus’ for Certain Drug Approvals

The Food and Drug Administration (FDA) announced on February 28, 2012 it is seeking input on what it calls a “new paradigm” under which the agency would approve certain drugs that would otherwise require a prescription for over-the-counter (OTC) use under certain safe use conditions.

FDA said the safe use conditions would be specific to the drug product and might require the sale of the drug in predefined health care settings, such as a pharmacy. Additionally, some conditions of safe use could be designed to assist patients in self-selection of an appropriate drug or provide for follow-up monitoring during continued use. The conditions also could include requiring pharmacist intervention to ensure appropriate nonprescription use, the agency said in a notice published in the Federal Register.

FDA acknowledged that industry is developing technologies consumers can use to self-screen for a particular disease or condition and determine whether a particular medication is appropriate. For example, kiosks or other technological aids in pharmacies or on the internet could lead consumers through an algorithm for a particular drug product. The algorithm could consist of questions that help consumers properly self-diagnose certain medical conditions or determine whether specific drug warnings contraindicate their use of a drug, FDA said.

The agency said it also is considering whether the same drug product could be available simultaneously as both a prescription and as a nonprescription product with conditions of safe use. “Dual availability could help ensure greater access to needed medications by making obtaining them more flexible,” FDA said.

FDA said the requirement to obtain a prescription for appropriate medication may contribute to the “undertreatment” of certain common medical conditions, including high cholesterol, hypertension, migraine headaches, and asthma. For instance, some consumers do not seek necessary medical care, which may include prescription drug therapy, because of the cost and time required to visit a health care practitioner for an initial diagnosis and an initial prescription, the agency said. Some patients who obtain an initial prescription do not continue on necessary medication because they would need to make additional visits to a health care practitioner for a prescription refill. Additionally, some prescription drugs require routine monitoring by a doctor.

FDA said some doctor visits could be eliminated by making certain prescription medications available without a prescription but with certain other conditions of safe use that would ensure they could be used safely and effectively without the initial involvement of a doctor. In some cases, a doctor visit would be required for the initial prescription, but a certain number of refills could be authorized beyond those that would normally be authorized without a return visit under specialized conditions of safe use like with certain rescue medicines such as inhalers, the agency said.
In addition to improved health outcomes for consumers staying on their medications, the time and attention that physicians and other health care providers expend on routine tasks related to prescription refills reduces the time that they are available to attend to more seriously ill patients, FDA said. Eliminating or reducing the number of routine visits could free up prescribers to spend time with more seriously ill patients, reduce the burdens on the already overburdened health care system, and reduce health care costs.
“The world is changing and we have to change to with it,” said FDA Commissioner Dr. Margaret Hamburg. “We’re not talking about abandoning standards for safety and efficacy, we’re talking about leveraging opportunities in science so we can do a more effective job as regulators and also improve the drug development process.”
The over-the-counter-plus switch is one of several FDA proposals aimed at increasing access to established drugs or speeding up approval of experimental medications. After years of high-profile drug-safety cases in which the FDA restricted access to certain medications, the agency is increasingly highlighting its efforts help drugmakers get new innovative drugs on the market. The shift comes as drug companies and their allies in Congress have pressured the agency to speed up approvals. Interest in creating a third category of drug products – something other than prescription or over-the-counter status is not new. In October 2007, FDA announced a November 14, 2007 public meeting to discuss the creation of a “behind the counter” (BTC) class of drugs – i.e., a class of drugs available behind the counter at a pharmacy without a prescription but that would require the intervention of a pharmacist before dispensing. This meeting was followed by a March 2009 report by the Government Accountability Office (GAO) which laid out, among other things, arguments supporting and opposing the creation of a BTC drug category.

The FDA will hold a public hearing on the over-the-counter-plus proposal on March 22 and March 23, 2012 from 9 AM to 4 PM at the FDA’s White Oak Campus in Silver Spring, MD. Additional information on the meeting is available on the FDA Web site.