TRENDS & PERSPECTIVES
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Kahan
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In April, the Association of Medical Diagnostic Manufacturers (AMDM) held its 35th annual meeting in North Bethesda, MD. The two-day meeting covered various topics related to current issues affecting the IVD industry. Such topics included discussions on compliance, quality systems, new guidance documents, evolving trends, legislative and regulatory actions, and international regulatory requirements.
One of the speakers at the meeting, Jonathan S. Kahan, JD, a partner at Hogan & Hartson (Washington, DC) and a codirector of the firm’s food, drug, medical device, and agriculture group, presented an overview on FDA and the IVD industry.
In his presentation, Kahan made several remarks regarding laboratory-developed tests (LDTs). According to Kahan, the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) has shown no desire to regulate LDTs, nor does it have the resources to do so. FDA is also fairly comfortable with allowing those LDTs that are similar to standard reagent-based tests. However, if an LDT involves areas in which labs do not have the proper expertise (e.g., software), FDA will seek the necessary regulation. Kahan believes that high-risk LDTs will eventually be regulated through either litigation or legislation.
“Senator Edward M. Kennedy (D–MA) has already submitted the legislation, but it hasn’t gone anywhere, yet,” says Kahan. “But his bill is totally imbalanced. Overall, I think a well-drafted regulatory scheme passed by Congress based on risk is the way to go rather than letting the courts handle it on a case-by-case basis.”
Kahan also spoke about the regulation of genetic tests. He said that significant public health implications have emerged due to gaps in the oversight of genetic testing. According to Kahan, “The government has punted. It doesn’t want to stop the fast development of emerging technologies. But if it overlays FDA, everything comes to a crawl.”
Kahan added that such a laissez-faire approach to regulating genetic tests could result in a potential health danger (e.g., a false positive or false negative leading to a tragic event with bad publicity), which could then lead to a rush to greater regulation.
“For example, how about a woman having both breasts removed because she incorrectly thinks she has the BRCA gene, or someone committing suicide because they incorrectly think they will get Huntington’s? When this happens, and something like it surely will, there will be draconian legislation not unlike the Kennedy bill, or FDA will rush in and say that it is no longer exercising enforcement discretion,” says Kahan.
In addition, Kahan stated that IVD-related “trade associations, professional associations, and other interested parties should make their views known about the need to continue streamlining the IVD clearance and approval processes.” One way he suggested was the IVD Roundtable.
Originally set up as a meeting for IVD industry representatives and FDA officials to discuss concerns regarding IVD regulations, the IVD Roundtable meets three times a year to identify and openly discuss current and emerging issues of specific interest to the IVD industry. In addition, the meetings provide an opportunity for FDA representatives to offer project updates and information about new agency initiatives. During the past few years, these meetings have also resulted in the development of several question-and-answer documents specific to topics of concern to both the IVD industry and FDA.
However, the IVD Roundtable has undergone some changes, primarily concerning less emphasis on issuing formal work products (e.g., question-and-answer papers, input to proposed guidelines) and more involvement in formal presentations by FDA and industry. Nonetheless, the Roundtable is holding true to its original purpose of improving communications between FDA and the IVD industry by continuing to hold regularly scheduled meetings. Such meetings provide FDA and industry speakers with a forum to present current and emerging issues, including an opportunity for networking among the participants.
“In addition, one initiative resulting from early IVD Roundtable meetings is the 510(k) workshop sponsored by AMDM and OIVD, which has continued to be a successful meeting that is an excellent training tool to improve the quality of IVD submissions,” says Leif E. Olsen, director of regulatory sciences at Hogan & Hartson and a member of IVD Technology’s editorial advisory board. “The workshop is a regularly scheduled annual two-day event that coincides with AMDM’s annual meeting.”
Established in 1973, AMDM is a nonprofit trade association that serves as an educational resource for regulatory submissions and other compliance information related to the IVD industry. Its membership includes IVD companies of all sizes that manufacture and distribute IVD products, as well as consultants and other suppliers providing essential materials and services to the industry. AMDM is known for providing educational conferences in which FDA and other regulatory bodies comfortably share information and exchange ideas with industry.
Additional information about AMDM and the IVD Roundtable can be accessed via AMDM’s Web site at www.amdm.org.
