NMA: Nonprescription Medicines Academy

FDA Considers Making More Medications Available Without a Prescription

April 4th, 2012

The FDA is holding a public hearing on March 22 and 23 to obtain input on a new paradigm under which certain drugs that otherwise would require a prescription would be made available on a nonprescription basis under conditions of safe use. The conditions of safe use would be specific to each drug product and might require sale in certain predefined health care settings, such as a pharmacy. Conditions of safe use also could involve the use of innovative technologies (e.g., interactive touch-screen kiosks) that would enable consumers to self-screen for a particular disease or condition and determine whether a particular medication is appropriate for them.

In the meeting announcement that appeared in the Federal Register on February 28, 2012, the FDA noted that requiring patients to obtain a prescription for appropriate medication, as well as make one or more visits to a prescriber, may contribute to undertreatment of common medical conditions such as dyslipidemia, hypertension, migraine headaches, and asthma. Making certain medications available without a prescription—or authorizing a certain number of refills without a return visit to the prescriber—has the potential to improve health outcomes for consumers and free up prescribers to spend time with more seriously ill patients.

Pharmacist intervention is among the conditions of safe use mentioned in the Federal Register announcement. For example, some diseases or conditions might require confirmation of a diagnosis or routine monitoring using a diagnostic test (e.g., a blood test for cholesterol levels or liver function) that could be available in a pharmacy. The pharmacist would evaluate a patient’s test results to determine whether use of a certain drug product is appropriate. Other potential roles for pharmacists include assessing whether the consumer has any contraindications to drug use, as well as assisting the consumer in choosing between various drug products.

As this new paradigm is currently envisioned, candidate medications would be approved for nonprescription use on a case-by-case basis pursuant to a New Drug Application (NDA). The NDA may need to include patient studies, such as self-selection studies, label comprehension studies, and actual use studies. If a diagnostic test or computer self-diagnosis algorithm is necessary as a condition of safe use, evidence may need to be submitted demonstrating that the test or algorithm will perform its intended function and can be administered appropriately in its intended setting.

The complete notice of public hearing is available online at http://www.gpo.gov/fdsys/pkg/FR-2012-02-28/pdf/2012-4597.pdf. Comments about the new paradigm are being accepted until May 7, 2012.