Sunscreen TEAs Could Illuminate How Deadlines Influence FDA’s Process

CHPA says FDA’s work on sunscreen TEAs under deadlines already set will give an idea of the impact from changes Congress imposed for FDA’s TEA process. But the industry will not know whether the changes benefit introducing other new OTC ingredients until FDA establishes and follows process deadlines.

The jury’s still out on how changes Congress imposed on FDA’s process for OTC ingredient time and extent applications will influence introducing new nonprescription drug ingredients, though the agency’s work on sunscreen TEAs should provide evidence for a verdict.

The Sunscreen Innovation Act Congress passed in October sets hard deadlines in FDA’s process of considering and evaluating TEAs for ingredients to add to the OTC sunscreen monograph, beginning with determining whether a sunscreen TEA is eligible for review within 60 days of receiving it.

For TEAs to amend other OTC ingredient monographs, though, lawmakers allowed FDA to determine the timelines it will follow. The act requires FDA to publish proposed regulations with timelines for other TEA reviews by around mid-2016, allowing that the timelines “may vary based on the content, complexity, and format of the application.”

Sponsors of other OTC ingredient TEAs already found eligible to be evaluated for inclusion in the monograph system can ask FDA to provide a review framework. Those requests should be made within 180 days of the act’s enactment because FDA must within one year provide a framework to each sponsor that submitted a request (Also see "Sunscreen Innovation Act Starts Clock Ticking On FDA Review Of TEAs" - Pink Sheet, 17 Nov, 2014.).

The Consumer Healthcare Products Association says the pharma industry and consumers will not know whether the TEA system for other OTC ingredients is improved until FDA establishes process timelines and makes decisions on TEAs under those timelines.

FDA’s work on sunscreen TEAs within the deadlines set by the act, however, will give an idea of the impact (see box below).

“We’ll benefit a little bit over the next few months in terms of what comes out with the sunscreen ingredients,” CHPA Associate General Counsel Carolyn Herrmann said. “This is really kind of a source we can study going forward,” she added.

Deadlines ‘A Good Start’

As other stakeholders told FDA in comments on improving the OTC monograph amendment process, CHPA says TEA process deadlines alone likely will not generate significant improvements. FDA in February 2014 published a notice for comment on overhauling its OTC drug monograph process to be “more agile and responsive” (Also see "FDA Floats OTC Monograph Overhaul To Be “More Agile And Responsive”" - Pink Sheet, 24 Feb, 2014.).

Hermann pointed out that imposing deadlines on FDA does not mean the agency will always deliver positive results on TEAs faster. “They obviously don’t mandate whether the FDA has to accept or reject an application,” she said.

In its comments on updating the monograph system, CHPA suggested FDA streamline the existing three-step TEA process to two steps to reduce redundant data requirements. The trade group recommended FDA first conduct a threshold review of an ingredient’s eligibility to be included in the monograph, and if this standard is met, allow the ingredient to be marketed on an interim basis while an amendment to the monograph is pending (Also see "TEA Changes, GRASE Basics Central To CHPA Monograph Comments" - Pink Sheet, 15 May, 2014.).

CHPA also suggests applying to the monograph process the temporary use permits FDA issues for food products that do not conform to standards of identity, allowing marketing of new products while the agency conducts a rulemaking to amend the relevant standards of identity.

Additionally, the Sec. 505(b)(2) process for deviations from a monograph that require safety and efficacy data not already included in a monograph can provide an amendment pathway, CHPA commented. Sec. 505(b)(2) was added to the Food, Drug and Cosmetic Act by the Drug Price Competition and Patent Term Restoration Act of 1984 – the Hatch-Waxman amendments – and permits FDA to rely, for approval of an NDA, on data not developed by the applicant.

The trade group also asks FDA to consider establishing a more formal collaborative partnership with stakeholders to collect and evaluate available data; says appropriate use of FDA’s enforcement discretion is a critical tool to expeditious monograph changes; and asserts the regulated industry is willing to cooperate in adopting labeling changes, conducting studies or removing ingredients from marketed products before formal rulemaking procedures are completed.

Hermann noted the while the recently passed legislation is limited to imposing TEA deadlines, “I think what this produces is a good start.”

“This hopefully will address some of the issues that we’ve had under the monograph system when it comes to time and extent applications,” she added.

FDA in 2002 established the TEA process as a pathway for adding substances to an OTC drug monograph that have been marketed “to a material extent and for a material time” – in a foreign market, for example – and have safety data to back them up.

Sunscreen TEAs As Timelines Template

Under the Sunscreen Innovation Act, after determining that a sunscreen TEA is eligible for review FDA will:

• allow 45 days for public comment supporting or otherwise relating to an ingredient’s determination on being generally regarded as safe and effective.
• within 60 days of a comment period ending determine whether a sponsor’s data and other information “are sufficiently complete, including being formatted in a manner that enables [the agency] to determine the completeness of such data and information[and] conduct a substantive review.”
• within 300 days complete the review and issue a proposed sunscreen order either approving or rejecting the ingredient for addition to the monograph, or convene an advisory committee meeting to review a request.
• following publication of a proposed order and a 45-day comment period, the agency has 90 days to issue a final order on whether an ingredient is approved or rejected for a monograph.

However, should FDA determine a sponsor’s data are insufficient and additional information is necessary to determine whether a proposed sunscreen ingredient is GRASE, the agency must issue a final rule within 210 days if an advisory committee meeting is not conducted, or 270 days if an advisory committee discusses a TEA.

Additionally, if FDA refuses to accept a TEA for review at the beginning of the process, the sponsor within 30 days can request a meeting with FDA officials to discuss the decision.