Do not disregard FDA warnings, pharma told

The US Food and Drug Administration has revealed that during 2000, itissued about 1,180 warning letters to pharmaceutical and cosmetics manufacturers, health care facilities and food companies, compared with 900 in each of the two preceding years.

Moreover, the recent warning letters sent by the agency to pharmaceutical majors such as Schering-Plough (Marketletter February 26) and Eli Lilly (Marketletter March 19) concerning Good Manufacturing Practice standards violations send "a signal to everybody else" in the industry, according to attorney Alan Minsk, a specialist in FDA regulation. Speaking at an Institute of Validation Technology conference in Boston, reported by Reuters, Mr Minsk said the big firms used to regard warning letters as a slap on the wrist, but with major players being reprimanded, and more severe penalties such as the $100 million fine imposed on Abbott Laboratories some years ago (Marketletter October 11, 1999), no-one in the industry can regard themselves as immune from more severe FDA actions.

Moreover, the Boston meeting heard, investors do take warning letters seriously, as was illustrated by S-P's stock plunge in February after an agency letter disrupted production at the company's facilities in New Jersey and Puerto Rico, and the financial implications of possible FDA product seizures and recalls and plant shutdowns.