The U.S. Food and Drug Administration is responsible for protecting consumers from potentially threatening products. But a new Yale study found that the agency’s multistage review and alteration processes have potentially dangerous loopholes.
Led by Harib Ezaldein ’11, the team found that many dermatologic devices had been altered after going through the review process, with limited inspection from the FDA. After alteration, the products were not reviewed as thoroughly as they had been during their initial screenings. As a result, some devices were re-released with dangerous modifications.
“As more and more products are developed for dermatology, especially in the anti-aging domain where the interventions are elective, device drift could result in substantive changes that limit safety or effectiveness,” said School of Medicine professor David Leffell ’77, the senior author of the report. “While the trend towards evaluating real-world data may allow us to better understand both efficacy and safety, until that is broadly deployed, accessing and evaluating data from manufacturers is essential.”
All products approved by the FDA must undergo a follow-up review if any changes are made to a product’s design, manufacturing or labeling changes. Over the last 20 years, the study concluded, most assessments of dermatologic devices took the 30-day track; meanwhile, the strictest review — the panel track — was used the least. The popularity of the 30-day process increases the chance of mistakes in the review and can pose a threat to consumer safety, according to the study.
In theory, the selected track should correspond to the type of changes under review. But the research team found that a particular review track does not always correlate to its designated modification. For example, small post-market design changes should match up with the real-time review track. But the research team found that the FDA used that track for the corresponding change less than half of the time.
A more relaxed review process also may open the door to dangerous numbers of modifications. Some of the devices reviewed had undergone as many as 84 modifications.
“We should be focusing on increasing regular device reviews to ensure that current iterations do not drift too far in design or components than what was originally approved,” Ezaldein and co-author Jeffrey Scott said in a joint statement.
For the study, the research team looked at 27 dermatologic devices that had been approved by the FDA. Out of the 27, four had been recalled from the market after approval.
Despite the concerns raised with the FDA review paths, members of the team said they do not think current consumers are in any substantial danger as a result of alterations to products. The researchers did not find any instances of a change in a dermatologic device creating a Class-1 recall — a situation in which there is reasonable probability that a device would cause “serious adverse health consequences or death,” according to the study.
“Dermatologic devices are overall quite safe,” said Ezaldein and Scott. “Life-threatening danger to patients, such as blindness or stroke, can still occur but are largely operator-dependent — when injected by inexperienced providers or in critical anatomical areas or when used off-label.”
The FDA created the review track system in 1980.
Allen Siegler | allen.siegler@yale.edu