Warning Letter “Templates” Likely Part Of GMP Proposal In August

The Center for Drug Evaluation & Research is likely to propose warning letter "templates" as part of its revisions to the Good Manufacturing Practices regulations coming out in August.

The goal of the templates will be to streamline the warning letter issuance process by defining certain categories of letters that do not require a thorough vetting by the Office of the Chief Counsel.

OCC began signing off on all enforcement letters under an HHS policy implemented at the end of 2001 (¹ (Also see "FDA Warning/“Untitled” Letters Will Be Reviewed By Chief Counsel" - Pink Sheet, 17 Dec, 2001.), p. 30). As one of the first steps in the ongoing GMP initiatives, the centers took over authority for issuing warning letters from the field in March 2003 (² (Also see "FDA GMP Initiative Shifts Warning Letter Review Back To Agency Centers" - Pink Sheet, 24 Feb, 2003.), p. 3).

OCC is encouraging the centers to develop templates to help reduce the administrative burden of the vetting process. With formal sign-off authority now in the hands of the centers, OCC may also be more confident in its ability to monitor standards through spot-checks.

Critics of direct-to-consumer advertising seized on the chief counsel's expanded role in enforcement letters as evidence that FDA is becoming more lenient about promotional standards.

A General Accounting Office report issued a year after the OCC review process was implemented suggested it was delaying the issuance of warning and "untitled" letters. FDA responded by adding more lawyers to the review effort (³ (Also see "DTC Ad Letter Review Cited By GAO; Chief Counsel’s Office Adds Two To Task" - Pink Sheet, 9 Dec, 2002.), p. 3).

Although it has not received as much attention, there has also been a sharp decline in GMP warning letters over the last two years. FDA issued 70 warning letters in fiscal 2001, declining to 58 in 2002 and 29 in 2003 (⁴ (Also see "GMP Warning Letter Downward Trend Accelerates; Few Oral Solids Get Cited" - Pink Sheet, 3 May, 2004.), p. 46).

The factors contributing to the decline are numerous and reach well beyond any inefficiencies in the review process. Nevertheless, administrative simplification efforts could help protect FDA from claims that it is backing off on enforcement.

[Editor's note: A detailed analysis of FDA drug GMP warning letters for fiscal year 2003 is included in the April issue of ⁵ "The Gold Sheet" . For a sample copy, call customer service at 800-332-2181.]