DeLauro Calls on FDA to Stop Plans to Outsource Key Agency Function

New guidance document suggests FDA would outsource decisions regarding the effectiveness of previously-approved antibiotics

Washington, DC – Congresswoman Rosa L. DeLauro (D-CT) today sent a letter to Commissioner Margaret Hamburg of the Food and Drug Administration (FDA) urging the FDA to suspend the process that would outsource decisions regarding the effectiveness of previously-approved antibiotics to a ‘standards setting' organization.

"Determinations regarding the effectiveness of antibiotics are an essential function of the FDA," Rep. DeLauro wrote. "Those efforts should be held to the same high standards as determination of effectiveness for other drugs. Any proposal that would outsource this work is highly questionable and would reflect poorly on the FDA."

The full text of the letter is as follows:

November 10, 2009

Margaret Hamburg, M.D.

Commissioner

U.S. Food and Drug Administration

U.S. Department of Health and Human Services

10903 New Hampshire Ave Silver Spring, MD 20993-0002

Dear Dr. Hamburg:

I am writing to express my concern over the plan to outsource efficacy testing as indicated in a section of the guidance document, Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices. The section that is of most concern suggests that the Food and Drug Administration (FDA) would outsource decisions regarding the effectiveness of previously-approved antibiotics to a ‘standard setting' organization. It is very troubling that the agency would consider outsourcing an essential function. Therefore, I strongly urge you to suspend this process immediately.

Recently, an FDA Advisory Committee met to discuss the implementation of the guidance document, and although not stated explicitly in the guidance document, the organization being considered is the Clinical and Laboratory Standards Institute (CLSI), a nonprofit public/private partnership. CLSI would provide updated post-market information that the FDA would accept to make decisions about the effectiveness of antibiotics for treating humans.

As you know, determinations regarding the effectiveness of antibiotics are an essential function of the FDA, and those efforts should be held to the same high standards as determination of effectiveness for other drugs. FDA decisions about antibiotic resistance and efficacy of drugs already on the market should be based on data from outcomes of clinical studies in humans, not the kinds of test tube studies or animal studies that CLSI primarily relies upon to make its determinations. Any proposal that would outsource this work is highly questionable and would reflect poorly on the FDA.

Congress has provided a substantial increase in appropriations to the FDA in recent years in order to provide the FDA with the resources it needs to do its job. As a regulatory agency, the FDA has essential safeguards in place to minimize potential conflicts of interest among those making decisions about efficacy and safety. Public health safeguards cannot be duplicated if the agency's work is primarily conducted by an outside entity, regardless of whether that entity is a nonprofit organization or a for-profit organization.

This is especially true of a membership organization that receives dues from companies that are regulated by the FDA, whose members include drug company employees and which sells products to those same companies. In addition, the consensus process used by CLSI includes the drug sponsor, and that approach is not appropriate for research interpretations used by a regulatory agency.

CLSI is a well-respected organization that helps determine standard conditions for growing organisms relevant to antibiotics, and their work is highly regarded. However, developing standards is a very different task compared to interpreting the results of studies to evaluate disease outcomes for drugs taken by human patients. The results of such studies have implications for the health and lives of all Americans, as well as enormous implications for the cost of health care. When evaluated in test tubes, older drugs may compare unfavorably to newer, more expensive drugs. However, the older drugs still could provide treatment results that are equivalent, or even surpass the newer, more expensive drugs.

The recent FDA Advisory Committee meeting was especially troubling because of the bias and conflicts of interest that were apparent. They include the following:

· The questions posed to the panel assumed these tasks would be outsourced, as opposed to examining whether they should be outsourced. There is some question as to whether these are appropriate questions for an advisory committee to consider given that this is a high-level policy issue that affects FDA as a whole.

· The morning session for "Stakeholders" did not include any presentations by patient groups or consumer organizations, but included the Pharmaceutical Research and Manufacturers Association (PhRMA) and CLSI.

· Several members of the Advisory Committee also were members of CLSI, but that information was not made public and no waivers were required for these very obvious conflicts of interest. When the CLSI membership of three Advisory Committee members was brought to the attention of the FDA prior to the meeting, those members did not participate on the panel, but others with CLSI connections continued to serve. For example, one committee member received an award from CLSI in 2007 and, during the meeting, expressed strong support for giving CLSI the responsibility of evaluating antibiotic resistance.

The effectiveness of antibiotics, including antibiotic resistance, is a critical public health issue that should be tested through studies of outcomes in human disease based on current FDA regulations for all drugs, whether new or old. The interpretations of any studies should not be outsourced and should be done by scientists at the FDA. This should be done in the same manner as is required of post-market assessments of other drugs, and therefore should include independent review by the Office of Surveillance and Epidemiology.

Thank you for your attention to this issue. I look forward to hearing from you regarding the agency's plans to resolve these issues, and to working with you to ensure that a critical function of the agency is not outsourced. The FDA's Office of Antimicrobial Products should continue to make decisions about the effectiveness of previously-approved antibiotics, and be allowed to move forward on the long-overdue post-market testing of antibiotic-resistance of previously approved drugs. Sincerely,

ROSA L. DeLAURO Chairwoman

House Appropriations Subcommittee on Agriculture Rural Development, Food and Drug Administration, and Related Agencies