Innovative Rx-to-OTC switches could be considered under FDA’s’ existing regulatory framework, nonprescription drug program chief Theresa Michele says in encouraging firms to make proposals.

The Division of Nonprescription Drug Products is reviewing comments on the Nonprescription Safe Use Regulatory Expansion initiative announced in 2012 to consider regulatory changes that would make more products available nonprescription to address under-treatment of common ailments, including chronic conditions such as high cholesterol and diabetes Also see "FDA Digs Deeper On “New Paradigm” To Expand Rx Switches" - Pink Sheet, 5 March, 2012.

FDA also is meeting with industry stakeholders and “exploring options within the agency for how to make this a reality,” Michele said Oct. 27 at the American Conference Institute’s meeting on OTC drug regulations.

However, changing FDA regulations is a lengthy, contentious process and likely would require legislation that grants the agency additional authorities.

“If regulations are needed, that’s a big issue for industry and really for everybody because … rulemaking is quite slow and difficult,” food and drug law attorney Michael Labson said in his presentation at the conference in New York.

“If we wait for regulations, it’s just going to be a real long time before we see anything concrete come out of this,” Labson added.

Existing FDA regulations make approval of switches and other NDA OTCs contingent partly on whether sufficient information can be stated in a Drug Facts label on self-selection and dosing in addition to ingredients and any contra-indications and other warnings.

“The problem is not … that you have to do all of those things, but you have to do it all in the Drug Facts label,” Michele said.

But DNPD, restructured and renamed Oct. 1 as part of the Center for Drug Evaluation and Research’s reorganization (see box below), is interested in proposals for novel switches, which would use information other than Drug Facts label to instruct consumers on self-selection and safe use of a nonprescription product, that could be done under FDA’s existing regulations for making drugs available OTC.

“Right now we’re in an exploratory mode,” and when firms suggest submitting new drug applications for “something that would be worth engaging on, we’re not going to tell you no,” Michele said.

Novel approaches could include the use of technology, health care providers or label restrictions to help consumers correctly self-select and safely use a under “conditions of safe use.” The conditions would be specific to each product, such as limiting sales to pharmacies, requiring a consumer to confer with a pharmacist about whether a certain drug is appropriate or requiring the availability of a diagnostic technology suitable for use by consumers or pharmacists.

As other FDA officials have, Michele acknowledged that Drug Facts labels by themselves probably are less helpful to consumers than other methods for stating information on nonprescription drug selection and use could be, but the agency’s options are limited by the existing OTC regulations.

“Many of those ways might be much more effective than this little piece of real estate on Drug Facts labels. But those other conditions, we don’t really consider under the current paradigm,” she said.

“So we don’t consider websites or apps or any other technological means or other opportunities which you might have to educate the consumer so they can get all these things right about an OTC product.”

However, allowing information needed for nonprescription drug instructions to be provided outside of Drug Facts labels bodes well for public health, Michele added.

“Right now in the NSURE program we’re not ruling anything either in or out. I think there’s a lot of opportunity for creativity here.”

Rulemaking Equals Long Wait

Labson pointed out FDA already has approved switches based on information the products provide consumers outside of Drug Facts labels.

In each case, the switch sponsors voluntarily included additional conditions in their NDAs. FDA officials have said the agency needs additional regulatory to make approval of an OTC NDA contingent on drug marketers being required to restrict or limit distribution of their products.

The agency’s approval of OTC weight loss drug alli (orlistat 60 mg) in 2007 depended partly on “labeling beyond Drug Facts,” including a brochure provided with the product that discussed the need for diet and exercise and explained body mass index, said Labson, a partner at Covington & Burling LLP in Washington Also see "Alli Approved OTC For Weight Loss With “Goal Oriented” Indication" - Pink Sheet, 12 February, 2007..

Additionally, the approvals of Nicorette nicotine replacement therapy (2mg and 4mg gum) in 1996 and the original two-pill Plan B emergency contraceptive in 2006 came with the NDA sponsors voluntarily limiting distribution or access to the products and committing to post-market surveillance to monitor whether the restrictions were effective Also see "Plan B Pioneers OTC “Pharmacy Counter” Approval, Dual-Status Marketing" - Pink Sheet, 28 August, 2006.. Nicorette’s switch NDA also called for including in packages an audio tape and information about the firm’s telecounseling program ([A#05040070002]).

FDA Combines OTC Divisions

FDA reorganizes its OTC drug office for the second time in four years by combining divisions that separated the oversight of products approved though the new drug application process and those compliant with the OTC monograph system.

The Division of Nonprescription Drug Products comprises what since March 2010 had been the Division of Nonprescription Clinical Evaluation, with NDA product oversight, and the Division of Nonprescription Regulation Development, the monograph monitor, in FDA’s of Office of Drug Evaluation IV.

“The new unified division is well suited to provide consistency and efficiency in managing the complex issues related to all types of OTC products,” FDA’s Center for Drug Evaluation and Research said in a statement.

FDA through Oct. 31 had not changed the OTC program office listings in its online organizational nomenclature.

And DNDP Director Theresa Michele said Oct. 27 at an OTC drug regulatory conference that the division’s name probably was new to some.

“For those of you who are unfamiliar with that name, you should be,” said Michele, who had been acting DNCE director. “This is very exciting for us because we have been working on a merger of two divisions over the past year.”

FDA in 2010 split the Office of Nonprescription Products into two divisions in CDER’s Office of New Drugs, assigning them to the same ODE unit with the then-new Division of Medical Imaging Products. The Office of Nonprescription Products had been elevated from the Division of OTC Drug Products in 2005 Also see "FDA's ONP Reorganization Challenges Industry To Prioritize OTCs" - Pink Sheet, 15 March, 2010..

Those examples, Labson said, show that under existing regulations, there is “opportunity for label and labeling to go beyond Drug Facts. It’s got to be linked with what’s in Drug Facts, but it can go beyond that.”

“If you take these existing authorities, through the label and labeling and through the approval process and the approval letter, you can start to think about how that might work with the concepts” suggested in FDA’s NSURE notice.

“I don’t want to suggest that that go all the way ... to a fully worked-out kind of NSURE paradigm that FDA and other stakeholders have talked about so far, but I think you could get a good chunk of the way there,” Labson said.

A potential disincentive for novel switches or other nonprescription NDA approvals based on sponsors’ voluntary restrictions or limits on product sales is that FDA could not make approval of generic versions subject to the same restrictions Also see "FDA To Tackle Critical Generics Issue In Switch Paradigm Debate" - Pink Sheet, 12 March, 2012..

Michele noted pharma firms also might be tentative about submitting NDAs for OTC switches or for other new nonprescription drugs because FDA is considering whether to make changes to its evaluation and approval process.

“I recognize that that leaves you … in a bit of uncertainty because I’m sure that many people are coming to you and saying, ‘What about NSURE? When is it going to be in place?’” she said.

“I can’t give you any dates. I can’t even tell you exactly where it is in the process. But what I can tell you is that the division is very open to speaking with pharmaceutical companies who have programs that they fell might benefit from NSURE.”

Room For Innovative Switches Could Lurk In Existing FDA Framework

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