HUMAN DRUGS.

8241W Bristol-Myers Squibb, New York, NY, Oct. 27 (DDMAC). FDA stated that the firm's presentation of Hydrea and Droxia (hydroxyurea capsules) at a scientific conference promoting the drugs "in the treatment of HIV disease is an unapproved use," and insisted that the promotions lacked fair balance or were misleading because of the unapproved use. The letter also noted that the National Institutes of Health terminated a study due to higher toxicity in patients randomized to the treatment arm, which recorded two fatal cases of pancreatitis.

The letter stated that Bristol officials were "made aware of these events on or before Sept. 24, but in the presentation on Sept. 28, the Bristol-Myers Squibb representative discussed the use of hydroxyurea in HIV disease and promoted hydroxyurea as 'very well tolerated.'" The agency requested that the firm "immediately cease the dissemination of the promotional materials" in question and submit a "Dear Healthcare Provider letter" correcting the "misleading information." FDA also recommended that the letter be sent to all attendees at the Sept. 28 conference and any healthcare providers who may have received information on the drugs' use for treatment of HIV. The letter stated further that FDA "may determine that additional remedial measures may be necessary." AE, F-B, Ol-Use

8242W Chemrite, Lannon, WI, Oct. 19 (Minneapolis). FDA cited the maker of OTC drugs for failure to: validate production processes; validate cleaning processes for utensils; conduct appropriate training; of the QC unit to review written procedures; prepare master production and control records; and determine actual yield and percent of theoretical yield of drug products. The letter noted that reserve samples must be held for products exempted from expiration date regulations. The agency recommended a meeting between company officials and agency personnel due to "recurrent GMP problems cited in a warning letter issued to your firm in 1996," as well as inspections in 1997 and 1998. The inspection took place on Sept. 28-30 and Oct. 1 and 6. VAL 

8243W Clinical Pharmacology Associates, Miami, FL, Oct. 18 (Office of Compliance). A clinical investigator whose name was redacted was cited for failing to protect the rights, safety and welfare of subjects in that effective means of contraception were not employed by study subjects. The letter stated that two subjects became pregnant during the study. Also noted were failure to: provide consent information in a language understand- able to subjects; maintain drug disposition records; and follow defined randomization schedules. FDA alerted the physician that "the clinic's current practice of allowing subjects to help in the kitchen is not acceptable for bioavailability/bioequivalence studies wherein subjects receive controlled diets." The investigation took place during February and March.