House Pushes FDA To Expedite Sunscreen Ingredient Reviews
This article was originally published in The Tan Sheet
Executive Summary
Reps. Dingell and Whitfield ask for FDA’s assistance on legislation they are writing to expedite the agency’s review of additional sunscreen ingredients. CDER Director Woodcock pledges FDA help, but explains the agency’s OTC ingredient reviews are “backlogged.”
Backlogs in the monograph OTC drug system and the structure of the ingredient review process have hamstrung FDA in the task of modernizing sunscreen regulations, drug center chief Janet Woodcock told lawmakers planning to file legislation to expedite completion of the regulations.
On Nov. 15, Reps. Ed Whitfield, R-Ky., and John Dingell, D-Mich., asked Woodcock, director of the Center for Drug Evaluation and Research, when the agency will respond to draft legislation on sunscreen ingredient reviews that they sent to FDA in April 2013.
Woodcock, on Capitol Hill for a Health Energy and Commerce Health Subcommittee hearing on implementation of the 2012 FDA Safety and Innovation Act, acknowledged the lawmakers’ frustration with FDA’s progress in determining whether to allow additional active ingredients for OTC sunscreens.
“This is a very intractable problem. If possible, we are more frustrated than the manufacturers and you all are about this situation,” she said.
The CDER director did not say when Whitfield and Dingell should expect the agency to respond to their request, but pledged the agency’s help. “We hope you will get a prompt response,” she said, adding “there’s a public health issue here” and “we will provide any assistance needed.”
However, she reminded the members that FDA must follow arduous and complicated procedures to determine whether to approve additional OTC drug ingredients.
“We have to follow regulations to get these ingredients into monographs. That’s the problem, and they’re backlogged and they’re slow to get through,” she said.
“We have to do proposed regulations, sometimes we do advanced notice of proposed regulations, then do a proposed rule and then do a final rule, which can take six to nine years. We have multiple categories of these over-the-counter products that we have to handle,” Woodcock said.
Whitfield, a 10-term member, during the hearing acknowledged FDA’s workload, but pointed out Congress repeatedly has asked the agency to complete its sunscreen ingredient evaluation.
Whitfield’s staff said Nov. 22 that FDA had yet to respond with comments about the members’ draft legislation. The draft bill was not disclosed.
Dingell, elected to Congress in 1954 and now the longest-serving House member in U.S. history, also noted the unusually long period during which FDA’s sunscreen ingredient work has remained incomplete. He said the “prodigious, overlong delay” has “simply got to come to a halt.”
“It’s a significant problem that does the FDA no credit whatsoever.”
Michael Werner, an attorney representing the Public Access to SunScreens Coalition, which includes manufacturers, suggested that the bill may be introduced soon if FDA does not act swiftly on the matter.
“I would imagine that if FDA doesn’t come forward over the next several weeks, [Congress] will introduce legislation. That’s just a guess,” said Werner, a partner with law firm Holland & Knight. “I think that you could tell that patience was wearing thin at that hearing.”
According to a release, Whitfield and Dingell also are working with Sens. Jack Reed, D-R.I., and Johnny Isakson, R-Ga., “to reform the FDA’s approval process for sunscreens and clear the current application backlog.”
In June 2013, Reed and eight democratic senators wrote a letter to FDA Commissioner Margaret Hamburg asking the agency to resolve sunscreen issues that remain in regulatory limbo, including the delay on sunscreen active approvals.
TEA Changes Suggested
FDA’s most recent regulatory update for sunscreens was a June 2011 final rule requiring products that fail “broad spectrum” tests or have an SPF less than 15 to warn that they have not been shown to prevent cancer or early skin aging. The rule allows products with SPF 15 or higher and that meet new broad spectrum tests, which measure UVA and UVB protection, to claim they decrease the risk of skin cancer or early skin aging caused by the sun (Also see "FDA Strengthens Sunscreen Testing And Label Requirements" - Pink Sheet, 20 Jun, 2011.).
The agency simultaneously released a separate proposed rule to ban sun-protection factor values higher than 50; an advanced notice of proposed rulemaking to gather more information about sunscreen dosage forms; and a draft enforcement guidance to help industry comply with all three regulatory documents.
The final rule is not the long-awaited OTC sunscreen ingredients final monograph, but addresses some issues raised in the 2007 proposed monograph. FDA noted in the final labeling rule that it was still evaluating other issues in comments to the proposed monograph and would address them separately in the future.
Stakeholders including PASS are pressing FDA to reform its sunscreen reviews, including changing the time and extent applications process to facilitate ingredient evaluations. FDA officials have said the agency is working on a new paradigm for TEAs and is making progress on several long-delayed applications (Also see "PASS Presses FDA To Repair TEA Process, Facilitate Sunscreen Reviews" - Pink Sheet, 17 Jun, 2013.).
Eight active ingredients marketed by L'Oreal SA, BASF Corp., [Symrise AG], Merck & Co. Inc. and 3V Sigma are awaiting FDA evaluation under the TEA pathway. The process relies on rulemaking and was established in 2002 as a way to add ingredients with demonstrated safety records in foreign markets to the agency’s over-the-counter drug monographs.
“I think that folks that have looked at this have come to the conclusion that the rulemaking process is not a very efficient way to make decisions about safety and effectiveness of a sunscreen product,” Werner said.
As no ingredients have been approved yet through the TEA pathway, the bill could include language to disengage sunscreens from the traditional rulemaking process.
Sending the actives through an advisory committee for safety and efficacy evaluations may also be on the table, and could impose needed time constraints on the approval process.
PASS has proposed a user fee system as a way to provide FDA with the resources it needs to review the actives in a timely manner.
“We want this to be a win for FDA, a win for patients and a win for applicants,” Werner said. “The new process has to work for everybody – all stakeholders including the FDA. It has to be something that they think works and ensures that safe and effective products get to the market as soon as possible.”