Reps Prep Sunscreen Filter Legislation; FDA Frustrated By Backlog
This article was originally published in The Rose Sheet
Executive Summary
Without swift FDA action on eight sunscreen filters pending review, legislators intend to introduce a bill to alter the agency’s sunscreen approval process. House members questioned FDA Center for Drug Evaluation and Research Director Janet Woodcock on the status of the applications, some of which have been under agency review for more than 10 years.
Members of the House Energy and Commerce Health Subcommittee pressed FDA for answers on the status of eight pending time-and-extent applications for sunscreen actives during a recent hearing and announced their intent to introduce a bill to alter FDA’s sunscreen approval process.
In a Nov. 15 hearing reviewing FDA’s implementation of the Safety and Innovation Act, Rep. Ed Whitfield, R-Ky., and Rep. John Dingell, D-Mich., said they have already drafted legislation and submitted it to the agency for “technical assistance.”
They questioned Center for Drug Evaluation and Research Director Janet Woodcock on the status of their submission and the current state of sunscreen applications, some of which have been in the queue for more than 10 years.
She said she hoped they would receive a prompt response from FDA staff regarding the draft legislation, and suggested that the agency is “even more frustrated” than manufacturers and legislators about the application delay and backlog.
“This is a very intractable problem. We have to do regulations to get these ingredients into monographs,” Woodcock said. “We have to do a proposed regulation, sometimes we have to do an advanced notice of proposed regulation, then do a proposed rule and a final rule, which can take six to eight years. And we have multiple categories of these over-the-counter products that we have to handle.”
Despite the bureaucratic steps that must be taken, sunscreen delays represent a “public health issue” and the director said FDA’s legislative staff would provide any assistance needed regarding the legislation.
Dingell took the opportunity to underscore the importance of the issue at hand.
“This matter has been dawdled by prodigious, over-long delay,” he said at the hearing. “It’s simply got to come to a halt. … I urge you to resolve this problem, it’s a significant problem that does [FDA] no credit whatsoever.”
In a Nov. 15 release, Whitfield says he is drafting bicameral legislation with Dingell and Sen. Jack Reed, D-R.I., and Sen. Johnny Isakson, R-Ga., “to reform the FDA’s approval process for sunscreens and clear the current application backlog.”
In June, 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 (Also see "Senators Push FDA For SPF Cap, Spray Sunscreen Review" - HBW Insight, 10 Jun, 2013.).
Michael Werner, a partner with law firm Holland & Knight, 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,” he said in an interview with “The Rose Sheet.” “I think that you could tell that patience was wearing thin at that hearing.”
Werner staffs the Public Access to Sunscreens Coalition, a group of sunscreen industry stakeholders formed earlier this year to work with FDA and legislators to facilitate review of sunscreen actives (Also see "PASS Coalition Works Toward FDA Acceptance Of New(ish) UV Filters" - HBW Insight, 10 Jun, 2013.).
In September, the coalition urged the Centers for Disease Control and Prevention to push FDA to review the UV filter applications “at a time when cases of skin cancer outnumber the occurrence of all other cancers” (Also see "CDC Should Help Spur FDA’s Sunscreen Filter Review – PASS Coalition" - HBW Insight, 16 Sep, 2013.).
Legislation To Speed Up Approvals
It is unclear exactly what the potential legislation may entail, but it is likely to include procedures to facilitate approvals of the sunscreen actives.
The eight actives under consideration are marketed by L'Oreal SA, BASF Corp., [Symrise AG], Merck & Co. Inc. and 3V Sigma, and are awaiting FDA evaluation under the agency’s Time and Extent Application pathway. The TEA 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 also 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.”