December 16, 1998

The Honorable Jane Henney, M.D.
Commissioner
Food and Drug Administration
Room 14-71 (HF-1)
5600 Fishers Lane
Rockville, Maryland 20857

Dear Dr. Henney:

Congratulations on becoming Commissioner of the Food and Drug Administration (FDA). We look forward to working with you, Dr. Friedman, and others in the coming years. One issue particularly worthy of your early attention is implementation of a recent international harmonization agreement.

Recently, Committee staff met with senior FDA officials to discuss the agency's progress in implementing the U.S.- EU Mutual Recognition Agreement (MRA) on drug inspections. According to the MRA, the parties established a three-year transition period during which the parties will assess the equivalency of the FDA and the individual national inspectorates of the EU. Many of the questions asked at this meeting were familiar to the agency, and were essentially the same concerns expressed by Members at the October 2, 1998 hearing before the Subcommittee on Oversight and Investigations. But FDA still remains unable to share details on whether FDA has both the necessary resources and the expertise to undertake the many complex tasks required to determine equivalency during the transition phase.

According to the recently published final rule, to ensure equivalency under the MRA, the FDA at a minimum will need to: (1) review for each EU country whether it has the necessary laws, regulations, statutory mandate, and jurisdiction to conduct Good Manufacturing Practices (GMP) inspections on an equivalent basis to FDA's legal and regulatory structure; (2) investigate whether each country has the ability to conduct GMP inspections and fully enforce GMP requirements where there is any violation of GMP practices; (3) assess whether each country has an accountable inspectorate that has the necessary expertise, training, and funding to accomplish equivalent GMP inspections, and (4) assess whether each country has in place the appropriate mechanisms to assure professional standards, guard against conflicts of interest, and consider other factors which may affect inspections.

The MRA became effective December 1, 1998, but FDA has not updated its implementation plan of February 27, 1998. That plan lacks a basic strategy on how FDA will accomplish these tasks during the transition phase of the agreement. From our perspective, it is certain that this phase will require significant staff resources from FDA in addition to highly specialized expertise. As of this date, the FDA still cannot or will not provide the Committee with even a crude estimate of the staff requirements necessary to accomplish these tasks or where they will come from within the government. The implications of this agreement are too important to allow the agency to proceed without formalized plans that identify what is needed to accomplish the tasks associated with the agreement's transition phase.

We understand that FDA has held or is holding internal meetings to prepare for a Joint Sectoral Committee (JCS) meeting with the EU to be held sometime in early 1999. It is reasonable to expect that FDA should or will develop a strategic plan before the JCS meeting. Given the JCS meeting in early 1999 and our growing concerns with the increasing resource burden that may be placed on the agency, we are requesting that FDA prepare immediately a strategic plan detailing how the agency intends to undertake the multitude of tasks required in the agreement's transition phase. At a minimum the plan should include:

1. An identification of the milestones (with proposed dates) envisioned by the FDA for implementing this agreement;

2. A refined estimate (with supporting methodology) of the required FTEs to accomplish each step of the transition period. In addition, identify where such resources will come from within the agency. If FDA intends to rely on resources from other Departments (e.g., State or Commerce), please include a description of what role each Department will play, the total number of FTEs each has guaranteed to the FDA, and a description of how each arrangement has been formalized (e.g., Memorandums of Understanding, etc); and,

3. A methodology identifying the intended step-by-step procedures the Agency intends to follow for each country (e.g., what components will be examined, what laws and regulations reviewed, etc.). Please also identify the intended sequence FDA intends to follow in selecting EU countries for equivalency determination, and provide supporting justification.

Please provide a copy of the strategic plan, or, if none is yet available, copies of all relevant drafts, to us by the end of January 31, 1999. Your immediate attention to this matter would be greatly appreciated. If you have any questions, please have your staff contact Christopher Knauer of the Democratic Staff at (202) 226-3400.

Sincerely,

JOHN D. DINGELL, RANKING MEMBER
COMMITTEE ON COMMERCE

RON KLINK, RANKING MEMBER
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

cc: The Honorable Tom Bliley, Chairman
Committee on Commerce

The Honorable Joe Barton, Chairman
Subcommittee on Oversight and Investigations

Back to the Public Record Home Page