Document GKEjqjpe7V1R3z7BgN0m9EkQr

FILE NAME: CTFA (CTFA) DATE: 1978 Aug 4 DOC#: CTFA016 DOCUMENT DESCRIPTION: Letter ^{t JT iv * -rwi n * ' V A ~t iv .ii& > tto n u? ^fiigust 4, 1978 Dr. Donald Kennedy Commissioner Pood and Drug A d m in istra tio n 200 C S t r e e t , S.W . Room 6815 W ashington, DC 20204 Dear D r. Kennedy: The stro n g lik e lih o o d th a t t a l c i s c a rc in o g e n ic was the su b je c t o f a l e t t e r from D r. M arsh all E . Deutsch to the New England Jo u r n a l o f M edicine on February 16, 1978 (page 405 ). A more r e c e n t l e t t e r to the same jo u r n a l by Dra. W.R. Moorehead and T.O. Oei (June 15, 1978, pp. 1365- 66) sta te s th at: (a) t a lc i s s t i l l used by U .S . drug companies both in ' the m anufacturing process and as a f i l l e r in / certain ta b lets; / (b) a m ajor drug fir m "has n o t used t a l c in any o f the new drugs th a t i t has develo p ed in the l a s t fiv e years because i t reco gn izes the p o ssib le danger of t a lc ;" Cc) FDA r e g u la t io n s d isc o u ra g e i t s replacem ent in o ld e r dru gs because the new fo rm u la tio n w ithout t a l c would have to be resu b m itted and approved by the FDA-- and t h is procedu re would take a lo n g tim e . I f there i s good reason to b e lie v e -- even i f the evidence i s not c o n c lu s iv e -- th a t t a l c i s c a r c in o g e n ic , prudence would d ic t a t e th a t i t s use be e lim in a te d prom ptly in FD A -regu lated products such as drugs and co sm e tics. I t would be g r e a t ly a p p re c ia te d i f you would l e t us know what s te p s FDA i s ta k in g to a c h ie v e t h i s o b je c t iv e . SMW BG:pm Health R esearch G roup 2000 p Street, n .w ., Wash ington, D.C. 20036 (202) 872-0320