Sponsors interested in pursuing innovative Rx-to-OTC switches should open a dialogue with FDA now, rather than wait until the agency further develops its nascent new paradigm for expanding the availability of nonprescription drugs, an FDA official said.

FDA reviewers are open to discussing what can be done to facilitate switches under the current switch infrastructure on a product-by-product basis, said Riken Mehta, FDA’s technical lead for the Nonprescription Safe Use Regulatory Expansion initiative, at the American Conference Institute’s meeting on OTC drugs in New York Oct. 29.

Approaches could include the use of technology, health care providers or label restrictions to help consumers correctly self-select and safely use drugs in a nonprescription setting, Mehta said.

He did not make any promises about what types of conditions FDA might recognize as potentially facilitating a switch under the current system, which relies on consumers’ ability to appropriately select an OTC drug based on the Drug Facts label. But he did say the agency is open to ideas as it continues to explore NSURE’s goal of making more products nonprescription to address under-treatment of common ailments Also see "FDA Aims To “NSURE” Clarity About New Paradigm For OTC Switches" - Pink Sheet, 5 November, 2012..

OTC drug manufacturers do not have to wait for FDA to further develop the paradigm to suggest a role for new technology or health care providers in an Rx-to-OTC switch, he said.

This could encourage some sponsors to move forward with creative switch applications, even though they may be frustrated by the pace of NSURE development.

FDA launched NSURE to explore regulatory approaches to expanding the nonprescription drug market in March 2012 and despite the agency receiving 189 comments from stakeholders about the initiative and holding three meetings at the Engelberg Center for Health Care Reform at the Brookings Institute, Mehta said the project remains conceptual and suggested the timeline for it may be longer than some anticipated ([A#05131007005]).

The agency has not communicated a timeline for NSURE, but when Mehta introduced the program at the conference he told attendees to “put on your dreamer hat” and think about “what should the nonprescription market look like in 10 to 20 years?”

Mehta also said to his knowledge the Brookings Institute will not present a culmination of its research or recommendations for actions based on the three meetings it held about NSURE, but will provide summaries.

Private meetings addressed insurance and reimbursement issues associated with switches on Nov. 4, and innovative technology and nonprescription medications previously. The first meeting last November was public and addressed conditions of safe use as a novel solution for undertreated disease.

Frustrated by the pace of NSURE, health care attorney Paul Hyman said he worries the agency’s focus on the new initiative, which “may be useful down the road,” is delaying regulatory actions that the agency could take now.

“NSURE itself appears almost to be an academic exercise – examining legitimate and significant issues to be sure, but not obviously leading to any real regulatory initiatives,” he said in an email.

“Please note that I am not opposed to many of the various suggestions for improving the [switch] process,” but “there are serious questions as to when, or if, NSURE will result in any action, and if it does, whether it will actually expand the OTC drug market, or raise more obstacles to switch,” said Hyman, a partner at Hyman, Phelps & McNamara in Washington.

NSURE Should Allow Flexibility

Regulatory action may not be necessary to enact some of the changes or suggestions gleaned from comments and the discussions at the Brookings Institute, said David Adams, a partner at Venable LLP and former associate chief counsel for enforcement in the Office of the General Counsel at FDA.

He argues that approving switches with conditions for safe use is a policy decision for which the agency has plenty of precedent.

For example, he noted, FDA did not need new regulations to limit the sales of OTC weight loss drug alli to consumers 18 years and older with an online education program or for the inclusion of educational audio cassettes with the sale of Nicorette when it switched OTC.

Adams also said codifying regulations for NSURE does not make sense for a paradigm that demands flexibility for unique circumstances.

“You are not going to be able to foresee everything that can and should be done under the new paradigm” and include it in a regulation, he said, noting a better “approach should be fleshed out on a case-by-case basis.”

One way to maintain flexibility under NSURE would be to create labeling intended for the dispenser rather than for the patient, he said. Dispensing labeling could outline age restrictions or direct retailers if they need to confirm specific health information prior to sale without overloading the consumer with too much information, he said.

This also addresses concerns that generic competitors might not be held to the same conditions of safe use as volunteered by the brand product sponsor.

“If FDA establishes the conditions in dispenser labeling, generics will have to include the same conditions in their labeling. A generic drug approved in an ANDA must, with certain exceptions, have the same labeling as the reference drug,” he explained.

He added creating dispensing labeling would not require legislation or a regulation because “the definition of ‘labeling’ in section 201 of the Act is very broad, and would include dispensing labeling. FDA can review and can approve the labeling in the regular drug approval process. In this process the applicant creates and seeks approval for the labeling.”

Paths To OTC Expansion

An alternative to expanding access with regulatory changes, a process that could take a decade or more, is for FDA to “do a lot more with its current procedures,” Hyman said.

The agency is not effectively using the tools it already has to expand the number of products or ingredients eligible for OTC access, he said, such as time and extent applications.

TEAs allow firms to request the addition of an ingredient to the OTC monograph by showing it was marketed extensively and for at least five years as a nonprescription product in another country, but even FDA admits this route is “not an expedited process,” according to industry guidance Also see "Guidance Underscores FDA Practice Of Letting TEAs Steep" - Pink Sheet, 3 October, 2011..

Indeed, Hyman said no TEA to date has progressed beyond eligibility for inclusion in the monograph. The agency has posted Federal Register notices asking for data demonstrating general recognition of safety and efficacy for several ingredients’ indicated conditions. He added FDA should consider streamlining this and other processes, which might be more feasible in the short term than a new initiative.

For example, if FDA finalized the existing tentative final monographs, then firms could add drugs and indications to them by submitting new drug application deviations, which are for drugs that comply with the monograph except for one deviation, Hyman said. He noted deviations, such as a higher concentration of an active or a unique combination with another ingredient, are much less work than a full NDA because firms can rely on the monograph for most of the support material. But the monograph process has also been slow, limiting this option’s applicability ([A#00500320008]).

While NDA deviations could expand the variety of OTC drugs, it is not a route for switches or new drug classes or ingredients.

Another option is for FDA to more quickly and readily grant citizen petitions that ask the agency to amend a monograph to include a new ingredient or indication, such as one Colgate-Palmolive Co. submitted in 2012 asking FDA to establish monofluorophosphate/potassium nitrate/zinc citrate combination as rational, safe and effective, Hyman said Also see "Colgate Bids To Expand U.S. Toothpaste Lineup Through FDA Rulemaking" - Pink Sheet, 28 May, 2012..

He also suggested FDA improve the path to market for new monograph combinations by allowing combinations from different monographs.

Renewed dedication and a few minor tweaks to these paths may prove more practical and realistic than creating a new paradigm, Hyman maintained, stressing he still supports NSURE.

FDA Encourages Novel Switch Ideas, Though NSURE Remains Unsure

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