Bureaucratic gaffe delays new rulesThe Food and Drug Administration's release of revised good manufacturingpractices (GMP) guidelines may be delayed due to a regulatorysnafu caused by overzealous budget-cutters at the agency. Beforethe FDA can
The Food and Drug Administration's release of revised good manufacturingpractices (GMP) guidelines may be delayed due to a regulatorysnafu caused by overzealous budget-cutters at the agency. Beforethe FDA can release a final version of the GMPs, it must receivethe approval of a technical advisory committee that has not onlybeen dormant for the past several years but whose members areno longer authorized to serve on the panel. The two-year termsof the committee members have expired and the FDA is scramblingto put a new committee together.
The FDA's Division of Enforcement III in the agency's Centerfor Devices and Radiological Health has been forced to place anotice in the Federal Register asking for membership nominations.The time needed to obtain, review and select committee memberswill make it impossible to convene the committee before the beginningof 1995, according to Fred Hooten, director of the Division ofEnforcement III.
The delay means the revised GMPs will not likely be completedin final form until late March or April. Because the FDA is expectedto provide industry with a 180-day period before beginning enforcement,the new GMPs probably won't take effect until fall 1995 at theearliest.
The delay results from a bureaucratic faux pas at the FDA.SCAN has learned that top FDA officials targeted the technicaladvisory committee earlier in the year as one that could be eliminated.As a result, the lapse of members' terms did not appear to bea problem, except to the FDA staff charged with revising the GMPs.
Hooten and his colleagues argued that the technical committeewas required to review the revised GMPs before the revision couldbe issued.
"There was a push earlier in the year to deactivate certaincommittees and this particular committee got caught up in that,"Hooten said. "Once it was realized that this committee wasrequired by the (Food, Drug and Cosmetic) Act, it was decidedthat we needed to fill the membership."
But it took until summer for Hooten to make and win his casefor continuation of the committee. By then it became obvious thatthe terms of the committee members had all expired and new membershad to be picked.
Review by the GMP Advisory Committee is one of the final stepsin the rule-making process for revising GMPs. The first step wasaccomplished last November with publication of the proposed GMPsin the Federal Register. The FDA then sought and is now in thefinal stages of incorporating comments from the public into thatrevision.
It is expected that only about two or three of the nine committeemembers will not be completely familiar with the proposed revision,Hooten noted. In fact, most will probably not only have seen therevisions but will have had a chance to comment on them. At leastsome will have submitted comments and, perhaps, some of thosecomments will have been incorporated into the revision.
Going to a committee with the GMPs at this late date, therefore,raises the question of whether the exercise is more to satisfya bureaucratic technicality than to obtain substantive commentary.Hooten acknowledged that this technical requirement must be metand that convening the committee will meet that requirement, buthe added that several issues have yet to be resolved and the committeecould play a key role in their resolution.
One issue is whether component suppliers will be governed bythe GMPs; another will address whether the FDA will have accessto audit reports prepared by manufacturers regarding the performanceof their suppliers. The details on these two issues have not yetbeen worked out and the committee will have an opportunity toaddress them, as will the public, Hooten said.