CONCURRING STATEMENT OF COMMISSIONER ORSON SWINDLE
regarding
FTC v. Alfa Scientific Designs, Inc., et al. (File No. X000054)
and
FTC v. Chembio Diagnostic Systems, Inc. (File No. 992-3269)


Both of these settlements with manufacturers of rapid HIV tests provide strong injunctive relief for consumers against allegedly false and misleading claims about the accuracy of rapid HIV tests not approved by the Food and Drug Administration for sale in the United States. They demonstrate the FTC's continued commitment to law enforcement in this area. When rapid HIV tests give false negative results, individuals may forgo treatment and fail to take steps to avoid infecting others. Rapid tests not approved for sale within the United States are exported in bulk to foreign distributors and end-users such as health clinics and hospitals, many in developing areas of the world. Some of these tests remained in the United States and were illegally marketed by distributors over the Internet to consumers in the form of individual rapid test kits, leading to FTC actions against allegedly false claims of accuracy made by such distributors. See FTC v. Medimax, Inc., Case No. 99-1485-Civ-Orl-99A (M.D. Fla. Mar. 22, 2000); FTC v. Cyberlinx Marketing, Inc., Case No. CV-S-99-1564-PMP-LRL (D. Nev. Nov. 8, 1999).

As I stated in my concurring statement in Sovo Tec Diagnostics, Inc., law enforcement actions to protect consumers from false or deceptive claims about HIV tests are a tremendous public service.(1) But enforcement of the FTC Act cannot systematically address the export from the United States of potentially faulty HIV tests. The Alfa Scientific order requires compliance with export requirements enforced by the Food and Drug Administration and requires that the defendants obtain an FDA Certificate of Exportability for sales in foreign countries. Although these order provisions effectively increase the likelihood that defendants will comply with existing export laws, they do not address the potential flaws in the export regulatory scheme suggested in my statement in Sovo Tec. I am concerned that there may be unanticipated gaps in the current export regime that allow the export of some U.S.-manufactured HIV tests and test kits without independent scrutiny of their effectiveness, whether by the FDA or by a foreign government that authorizes the marketing of such devices.(2) A system designed to prevent wasteful, duplicative review may have led to the unintended consequence of ineffective review.

As I did several months ago, I urge the FDA and Congress to take a hard look at the current export regime to be sure that it is not inadvertently undermining U.S. and international efforts to combat the AIDS pandemic.

1. In Sovo Tec, the Commission settled allegations that a distributor and exporter of the rapid HIV tests manufactured by Chembio had violated the FTC Act by false claims about the tests' accuracy. FTC v. Sovo Tec Diagnostics, Inc., et al., C00-3468 BZ (N.D. Cal. Sept. 28, 2000). I wrote separately to identify questions about the treatment under current U.S. law of exports of U.S.-manufactured HIV tests and test kits not approved for sale in this country. See Concurring Statement of Commissioner Orson Swindle regarding Sovo Tec Diagnostics, Inc., File No. 992-3252, available at www.ftc.gov/os/2000/09/sovoswindle.htm. See also Concurring Statement of Commissioner Thomas B. Leary regarding Sovo Tec Diagnostics, Inc., File No. 992-3252 (agreeing with Commissioner Swindle's recommendation for a review of current export legislation and regulation), available at www.ftc.gov/os/2000/09/sovoleary.htm.

2. One of the requirements for export of unapproved devices under Section 802 of the Federal Food, Drug and Cosmetic Act is that the exporter obtain "valid marketing authorization" from at least one of the countries listed in the statute or added to the list by the Secretary of Health and Human Services. Currently listed countries include, for example, Australia, Germany, Portugal, Sweden, and the United Kingdom. Once marketing authorization is obtained, a device may be exported either to the country granting the authorization or to any other country that accepts the former country's marketing authorization. Thus, the statute contemplates that a developing country without its own system for assessing the effectiveness of the medical devices it imports may choose to rely on a listed country's marketing authorization. Yet, in practice, marketing authorization may not require an affirmative action or decision by a listed country allowing the device to be sold in that country. Instead, under the FDA's interpretation of the statute, a device has valid marketing authorization if the exporter obtains a document from the relevant governmental authority in the listed country indicating that the listed country does not object to the product's marketing. See 21 U.S.C.  382(b)(1)(A); FDA Draft Guidance for Industry on: Exports and Imports under the FDA Export Reform and Enhancement Act of 1996 (Feb. 1998), Food and Drug Administration, U.S. Dept. of Health and Human Services, part VII.D, available at www.fda.gov/opacom/fedregister/frexport.html.