FDA criticized for "unscientific scare-mongering" over new eczema drug

The row over a US Food and Drug Administration proposal to put a black-box warning on topical calcineurin inhibitor (TCI) products for atopic eczema on "spurious grounds" (Marketletter March 21) has intensified, with leading European dermatologists adding their voices to the protest lobby already established in North America.

During the 8th Congress of the European Society for Pediatric Dermatology, held in Budapest, Hungary, leaders of the European Academy of Dermatology and Venereology and the European Society for Pediatric Dermatology were the latest to register a strong protest.

Speaking at the meeting, EADV president Johannes Ring and Ramon Grimalt, general secretary of the ESPD, strongly criticized the FDA for what they said was taking an unscientific approach and indulging in unfounded scaremongering. "There is no clinical evidence whatsoever to support this warning. We think it is disproportionate and unjustified," said Prof Ring, adding: "we are angry because we don't want this to limit access to the drugs or cause unnecessary anxiety to patients or their caregivers."