Rx-to-OTC switches for nonsteroidal anti-inflammatory drugs (NSAIDs) should be considered on a case-by-case basis and should not require formalized guidelines, the Pharmaceutical Manufacturers Association and the Nonprescription Drug Manufacturers Association asserted in separate presentations to FDA's Arthritis Advisory Committee on Feb. 22. "As in all areas of drug development, decisions will need to be made on an individual, case-by-case basis," PMA Senior VP-Science & Technology John Beary, MD, said. "Each NSAID compound is unique and, even within chemical subclasses, differences exist that make generalization to the entire NSAID group very difficult." The committee met Feb. 22-23 to discuss possible development of written guidelines for approving NSAIDs for OTC use (see preceding story). The NDMA and PMA comments were among six presentations made during the first day of the two-day advisory committee meeting. While both associations approached the switch issue from a regulatory policy perspective, presentations by Public Citizen's Health Research Group, the Arthritis Foundation, the National Kidney Foundation, and the American College of Rheumatology addressed specific scientific and medical questions related to NSAID switches. While noting that clinical trials "conducted with the dosage strengths proposed for switch from Rx to OTC...remain the keystone of the drug approval process," Beary suggested that "innovative studies in this evolving area may supplement or, in some cases, obviate more traditional approaches." NDMA Director of Scientific Affairs William Soller, PhD, argued that existing FDA regulations already provide a workable basis for Rx-to-OTC switches: "The process for switch is in place ...The work of this Advisory Committee on Rx-to-OTC switch petitions should be able to continue uninterrupted without the development of switch guidelines." Soller recommended that FDA not require a "specific standard number of years that a product should be marketed -- or a specific number of Rx prescriptions filled -- before an Rx product is considered for OTC status." Further, the guidelines should not fix the number and type of trials needed to approve a switch, Soller argued, suggesting instead that "the specific trials that would be needed to establish a candidate as a general purpose OTC analgesic and/or antipyretic would be dependent on the nature of the Rx database for that candidate and therefore should be determined through cooperative discussions between FDA and the sponsor." Since this principle is already in operation, Soller noted, "formal guidelines on this issue would not seem to be needed." NDMA maintained that "the development of switch guidelines would lead to artificially restrictive...cookbook approaches" to the process of approving OTC switches. Soller pointed out that FDA has already developed a standard indication for "general analgesics" in its Tentative Final Monograph on internal analgesics. Therefore, Soller continued, clinical trials in some of these allowable indications should be enough to establish a formerly prescription-only NSAID as a general analgesic. "In other words, clinical trials in, for example, the pain models of dental extraction and/or menstrual pain or another model would be sufficient to establish an OTC dosage level of an Rx-to-OTC switch candidate as a general OTC analgesic, if the data in the [Rx] NDA were not to be sufficient in themselves," Soller stated. Soller also suggested that "in principle there should be no general requirements that a company explore anew a determination of the effective OTC dosage if the overall assessment of the product warrants its OTC availability based on the available Rx database." No companies made presentations, but NDMA and PMA both requested that the hearing record be left open for 30 days so that interested parties could comment. However, Acting Director of FDA's Pilot Drug Evaluation Staff John Harter, MD, said he was leaning toward holding the record open for 14 days.
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