The House Committee on Energy and Commerce recently held an oversight hearing which seen Dr. Janet Woodcock, director of the FDA Center for Drug Evaluation discuss pending sunscreen applications whilst also giving insight into why some processes take so long.
It was congressmen Ed Whitfield and John Dingell who specifically took Dr. Woodcock to task about some applications that they said had been waiting for a decision from the Administration for the last 10 years, despite being used on the European market.
Under the spotlight
Whitfield started the debate by commenting that he had attended a meeting with a group of dermatologists last April where the approval process was the main focus of the conversation.
“We all are aware the workload is heavy at the FDA and that resources are limited, but myself and other senators have drafted legislation to try to expedite the approval process, which we have submitted to you for technical assistance,” he explained.
The congressman then asked if the FDA director was aware of the submitted legislation and if so, when he and his colleagues could expect a response.
“We hope you will get a prompt response,” Dr. Woodcock responded.
She then explained that; “If possible, we are more frustrated than the manufacturers and you all are about this situation. The problem is that we have to do regulations to get these ingredients into monographs and they are backlogged and slow to get through."
The FDA director continued to give insight into why some processes take so long at the Administration's offices.
“We have to do a proposed regulation, and sometimes an advanced notice to that proposed regulation, then a proposed role and then a final role which can take 6 – 8 years. We also have multiple categories of these over the counter products that we have to handle,” she states.
“But the sunscreens, there’s a public health issue here,” she concluded.
The first ever sunscreen final rule in the US went into effect last year.