September 24, 1996 - Food and Drug Administration Reform

The Honorable Thomas Bliley, Chairman
Committee on Commerce
U.S. House of Representatives
2125 Rayburn House Office Building
Washington, D.C. 20515

Dear Chairman Bliley:

The American Society for Microbiology (ASM ) would like to submit comments on the proposed legislation to reform the Food and Drug Administration (FDA). The ASM is the largest single life science society in the world with over 43,000 members, working in university, clinical, and public health laboratories, as well as in industry and government. Our membership, especially those involved in clinical care, diagnostics, and clinical research, are dependent upon the quality of the diagnostic devices and the pharmaceuticals used in our work. The ASM believes that proposals to reform the FDA have the potential to improve patient access to new, innovative technologies that may assist with the diagnosis and management of a wide variety of infectious diseases and other conditions. Microbiologists rely on the availability of accurate medical devices to assist with the diagnosis and treatment of infectious diseases, including those associated with newly recognized infectious agents, antibiotic resistant microbes, and those affecting immuno-compromised groups (e.g. the elderly). ASM would like to make the following specific recommendations as Congress considers FDA reform legislation.

The diagnosis and management of infectious diseases rely on the availability of microbiology devices as well as their accuracy and efficacy. An inaccurate device that is rushed through the approval process may potentially cause additional harm to a patient suffering from an infectious disease. Marketed devices must provide reliable information. The user of the device must be able to understand the strengths and limitations of a particular device or pharmaceutical as it applies to a particular patient population. Accuracy, efficacy and timeliness are three goals that must be achieved as FDA reform is considered. One should not be compromised for the other.

The ASM supports efforts to require the FDA to meet certain device performance standards, including specific timetables for acting on new product applications. However, we are aware that the FDA has taken substantive steps to improve the timeliness of product review. This includes the development of a triage system that expedites the processing and approval of safe and uncomplicated devices. In addition, the FDA, Division of Clinical Laboratory Devices, has begun to carry out their own reforms with a pilot program utilizing third party reviewers for selected 510K submissions. The FDA should be commended for these efforts. This pilot program will test the feasibility of using third-party reviewers for selected 510(k) pre-market notifications for medical devices. The ASM recommends that before legislation is passed mandating third-party review, this pilot program be implemented. The pilot program is crucial to establishing whether third-party review is a practical and useful tool to augment the current FDA review process or if it may pose unforseen problems. The ASM does not support the establishment of a third party review mechanism for Pre-market Approval (PMA) and 510(k) applications unless the pilot program is proven to work, cost less, and it does not endanger the public health. It is important to note that since December, 1995, the Division of Clinical Laboratory Devices has met the statutory deadline of reviewing 510K submissions within 90 days.

If third-party review is mandated, the agency would be responsible for developing the criteria for "deeming" organizations, as well as reviewing and approving all third party recommendations within a specified brief timetable. Such a process would place additional responsibility on the FDA, without guaranteeing appropriate resources or staff, and potentially abrogating its responsibility to protect the public health. Currently, there are forty-three advisory committees that provide the FDA with technical and scientific "third-party" advice and assistance related to the development and evaluation of medical devices and drugs. Strengthening these already existing advisory committees and responding to their recommendations in a more timely fashion would facilitate product review and obviate the need for third-party reviewers.

Congress is also considering revising the data requirements the FDA imposes on manufacturers. According to manufacturers of microbiology devices, the more important issue is encouraging and promoting standardized guidelines and requirements at the FDA. The ASM recommends that the FDA standardize their data requirements for manufacturers. This would not compromise the public health but would be helpful to manufacturers and would reduce total costs of product development.

Thank you for considering the ASM's written recommendations for FDA reform. We would be pleased to provide further information and assist the Committee as FDA reform legislation continues to move forward.