CDRH, CBER halve output of warning letters in FY 03's first six months vs. 2002: Guaifenesin letters spike CDER totals.

Dear Reader,

A significant drop in warning letters coming out of the Center for Devices contributed to an overall reduction in letters issued by FDA's three major Centers for the first-half of fiscal year 2003 (Oct. 1, 2002-March 30, 2003) as compared to the same period last year.

On the whole, CDRH accounted for 91 letters in the first-half of fiscal 2003 versus188 letters the Center released in the first-half of fiscal 2002.

While totals from the three major Centers decreased modestly, compared to the first-half of FY '02 (217 letters compared to last year's 258), these totals can be deceiving when not taking into account certain anomalies.

For example, totals in October were thrown off by the release of 68 warning letters by CDER, all on Oct. 11, 2002 (See Warning Letter Bulletin, Nov. 4, 2002) concerning extended release dosages of guaifenesin. These letters were the result of the agency according new drug status on extended release dosages of the expectorant not covered under the OTC monograph.

Taking these letters out of the totals leaves 149 letters released by the three major Centers during the first-half of FY '03, or a reduction of nearly 42%.

Without the guaifenesin letters, CDER's output remained steady, releasing 49 letters over the six month period, compared to 53 released over the same period last year.

CDER received another spike in its number of letters released the next month, in November, when it released five Division of Drug Marketing, Advertising and Communication (DDMAC) letters, bringing the total of CDER letters released in November to 13.

Another less pronounced spike in DDMAC letters occurred from December to February, perhaps in anticipation of criticism from watchdog groups and Congress that DDMAC has been issuing fewer DDMAC letters (See, Warning Letter Bulletin, March 24).

Like CDRH, the Center for Biologics nearly halved the number of warning letters released for the first six-months of FY '03. Compared to the 17 letters released the first six-months of FY '02, the Center only released nine letters total for the same period this year.

Over the six-month period, CBER letters started out strong in October with three, and then fell into a slump by February when no letters were released at all.

Of the CDER total, eight letters were issued for medical gas violations. Stripped of medical gas and guaifenesin letters and a total of 12 DDMAC letters, CDER ended up only releasing some 29 letters over the first six months of FY '03.

Of the CDRH total, mammography violations accounted for 48 letters thereby leaving only 43 letters dedicated to medical devices.

A factor that likely contributed to the reduced volume of letters released by CDRH and CBER was the continuing requirement that all warning and untitled letters be reviewed by the Office of the Chief Counsel. This measure formally began in March 2002.

And in February, CDER announced that all of its warning letters would be issued by headquarters, not field offices.

Sincerely,

The Editors

Warning Letters Released First Half FY '03

         Mar.   Feb.   Jan.   Dec.   Nov.   Oct.

CDER        5     10      3      8     15     76 *
CDRH       17     11     13     11     18     21
CBER        1      0      1      2      2      3
Totals     23     21     17     21     35    100

* Includes 68 letters for Guaifenesin

Source: FDA Office of Regulatory Affairs