By Lisa Seachrist
WASHINGTON — Newly appointed FDA Commissioner Jane Henney has been at the job for less than a month. However, heading an agency that has operated without a permanent leader for 18 months leaves little room for easing into the job.
In a letter dated Dec. 16, House Commerce Committee Democrats have given the new commissioner a Jan. 31 deadline to establish a detailed plan for implementing the Mutual Recognition Agreement (MRA) between the U.S. and the European Union (EU) on drug inspections, which went into effect Dec. 1. At issue in the letter is whether the agency can implement the agreement with current resources, and adequately assure the safety and efficacy of drugs that fall under the new inspection regime.
"You can't really separate the two," a Commerce Committee staffer said. "If FDA doesn't have the resources, then they have no way to provide assurances of safety and efficacy. The committee has some questions, but they haven't reached any hard-and-fast conclusions on the situation."
The letter to Henney was signed by Rep. John Dingell (D-Mich.), ranking member of the House Commerce Committee, and Rep. Ron Klink (D-Pa.), ranking member of the committee's Subcommittee on Oversight and Investigations.
The MRA on drug inspections was designed to provide a means to avoid redundant manufacturing inspections by U.S. and European regulatory agencies. Currently, FDA inspectors travel to foreign manufacturing sites to ensure that they comply with Good Manufacturing Practices (GMP). The same facilities are examined by European inspectors.
The MRA calls for the creation of certification bodies in Europe and the U.S. that could complete inspections and verify that the manufacturing facilities conform to both local and foreign standards, thereby alleviating the need for both European and American inspections. A three-year transition phase to complete implementation of the agreement began on Dec. 1.
The Dingell and Klink letter, however, asserted that the agency has been "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."
The FDA has concluded that in order to ensure equivalency under MRA the agency needs to conduct a series of reviews of each EU country, to ensure that inspectors are adequately trained and accountable and to ensure each country has the necessary regulatory structure to enforce GMP standards upon finding violations. In addition, the agency must determine whether each country has in place appropriate mechanisms to guard against conflicts of interest, as well as establish professional standards.
The congressmen have questions about how the agency intends to accomplish these tasks during the transition phase. Noting that the general plan hasn't been updated since Feb. 27, 1998, the congressmen take the agency to task for operating without a "basic strategy." To date, the agency hasn't provided the committee any estimate of staff requirements.
The agency has stated it intends to implement the MRA using basic operating funds. However, in their letter, the congressmen note that the transition phase "will likely require significant staff resources from FDA in addition to highly specialized expertise."
The plan, which Henney is expected to submit to the committee by Jan. 31, is expected to include: an identification of milestones for implementing the agreement; a refined estimate of the FDA staff requirements, as well as staff requirements from other agencies; and a methodology identifying the intended step-by-step process FDA intends to follow for each country.
Pending Henney's reply, a commerce committee staffer said that the committee would evaluate whether hearings are necessary on the subject. The committee held a hearing Oct. 2, at which the agency maintained it intends to use currently available resources to implement MRA. After that hearing Joe Barton (R-Tex.) and Klink asked the General Accounting Office to estimate the likely cost of implementing MRA.
While the minority has made the request to Henney, the committee staffer noted that the issue "remains a bipartisan concern." *