Concurring Statement of Commissioner Orson Swindle
regarding

SOVO TEC DIAGNOSTICS, INC.

File No. 992 3252

I fully support the filing of this complaint and settlement resolving false claims about the accuracy of rapid tests to detect human immunodeficiency virus ("HIV"), the virus that causes AIDS. This settlement follows several Commission actions to protect consumers from false claims about the accuracy of HIV home use test kits.⁽¹⁾ These types of actions represent one of the best public services we can perform: protecting the public from false claims that can have a serious, potentially deadly impact on the health of consumers and others who may be infected by consumers acting in reliance on false test results. At the same time, it is important to recognize the limitations on the FTC's ability to deal with this problem.

The HIV tests and test kits that are the subject of recent FTC actions are not approved for sale in the United States, and two of the settlements previously obtained by the FTC ban defendants in those actions from participating in the marketing of these devices.⁽²⁾ Nonetheless, these cases leave unresolved a number of disturbing questions about the export from the United States of potentially faulty HIV tests or test kits. AIDS is a highly infectious, deadly disease that is not limited by geographic boundaries. International efforts to combat the spread of AIDS are supported by our government, but defective test kits may contribute to the spread of AIDS. In light of these considerations, should there be a public health mechanism in place in the United States to prevent the export of faulty HIV tests or test kits?

There is very limited U.S. government oversight of the export of U.S.- manufactured HIV tests and test kits not approved for sale in this country. Since the 1996 amendments to the Federal Food, Drug, and Cosmetic Act, U.S. manufacturers do not need FDA permission to export HIV tests and test kits not evaluated or approved by U.S. government health agencies, provided that the particular device (1) is in accord with the specifications of the foreign purchaser; (2) is not in conflict with the laws of the country to which it is being exported; (3) is properly labeled; (4) is not sold or offered for sale in U.S. commerce; (5) substantially meets "Good Manufacturing Practices" as that term is defined by the manufacturer or meets an international standard recognized by the FDA; (6) is not adulterated (other than lacking FDA marketing approval); (7) is not the subject of notice by the Department of Health and Human Services that the probability of re-importation would pose an "imminent hazard" to U.S. public health and safety, and the only means of limiting this hazard is to prohibit the export; and (8) does not present an "imminent hazard" to the receiving country.⁽³⁾ In addition, the HIV test or test kits to be exported must be authorized for marketing in at least one of the countries listed in Section 802 of the FDA Act ("listed countries") and may be exported either to that country or to any other country that accepts that country's marketing authorization.⁽⁴⁾ Thus, a country without its own system for assessing the reliability and effectiveness of medical devices it imports may elect to rely on a listed country's marketing authorization.

Several aspects of the current regulatory regime, as they apply to the export of unapproved HIV test and test kits, should be noted. First, FDA regulations regarding good manufacturing practices and quality systems leave it up to the individual manufacturer to determine its own quality requirements for each type of device and how to satisfy them.⁽⁵⁾ Second, the marketing authorization needed for export under Section 802 of the FDA Act does not require that the government of the listed foreign country take steps to determine the accuracy of an HIV test or test kit. In some listed countries, marketing authorization does not even entail an affirmative decision allowing the device to be sold in that country. Instead, the FDA considers such devices to have marketing authorization for purposes of export under Section 802 if the U.S. exporter merely 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.⁽⁶⁾ Third, it is not clear whether Section 802(f)(4)'s prohibition on the export of devices that pose an "imminent hazard" extends to HIV tests or test kits that pose a delayed hazard by providing users with inaccurate information that may delay them from seeking necessary health care and discourage them from taking steps to avoid infecting others with an ultimately deadly disease.

In addition, to assist in foreign marketing, a U.S. exporter of unapproved HIV tests or test kits may obtain a "Certificate of Exportability" issued by the FDA without any review or testing by the FDA to determine that the devices are accurate and reliable.⁽⁷⁾ Thus, the FDA may issue a document indicating its approval -- albeit one that states in the body of the certificate that the device is not approved for marketing in the U.S. -- to promote the foreign sale of unapproved devices not evaluated by anyone except the manufacturer under standards set by that manufacturer.⁽⁸⁾

The current regulatory regime thus relies almost exclusively on the government of the receiving country to protect its citizens from the import of potentially faulty devices manufactured in the U.S. As a practical matter, it permits the export from the U.S. of unapproved HIV tests and test kits without regard to their accuracy.

Is this the right approach when the policy, at least theoretically, can contribute to the global threat posed by AIDS? Should foreign governments be alerted when U.S. government authorities find that some HIV tests or test kits give false results, so that their import may receive more direct scrutiny by public health authorities in those countries? Should unapproved HIV tests and test kits receive closer scrutiny before the FDA issues a "Certificate of Exportability"?

The gravity of this disease and its devastating impact on the world's population warrant a hard look at whether current export laws and practices adequately address the export of devices that, if faulty, may contribute to the spread of AIDS. Accordingly, I urge the FDA and Congress to review the current regulatory regime in light of these questions.

Endnotes:

1. FTC v. Medimax, Inc., Case No. 99-1485-Civ-Orl-99A (M.D. Fla. Mar. 22, 2000); FTC v. Alfa Scientific Designs, Inc., Case No. 00CV 0081 BTM NLS (S.D. Cal. filed Jan. 13, 2000); FTC v. Cyberlinx Marketing, Inc. (D. Nev. Nov. 8, 1999); FTC Consumer Alert: Home-Use Tests for HIV Can Be Inaccurate, FTC Warns (June 1999), available at www.ftc.gov/bcp/conline/pubs/alerts/hivalrt.htm. See also FTC and FDA Warn Consumers About Ineffective and Unapproved HIV Test Kits; Announce Joint Law Enforcement Actions (Nov. 1999), available at www.ftc.gov/opa/1999/9911/cyberlinx.htm.

2. FTC v. Medimax, Inc., supra note 1; FTC v. Cyberlinx Marketing, Inc., supra note 1.

3. See Food and Drug Export Reform and Enhancement Act, Pub. L. 104-134 §§ 2101-05; 110 Stat. 1321 (1996), amended by Pub. L. 104-180, 110 Stat. 1569 (1996) (modifying Sections 801 and 802 of the Federal Food, Drug, and Cosmetic Act ("FDA Act"), 21 U.S.C. §§ 381-82).

4. 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 ("FDA Exports and Imports Guidance"), part VII.D., available at www.fda.gov/opacom/fedregister/frexport.html.

5. See 21 C.F.R. Part 820; Center for Devices and Radiological Health, Good Manufacturing Practices (GMP)/Quality System (QS) Regulations, Food and Drug Administration, Dept. of Health and Human Services, available at www.fda.gov/cdrh/devadvice/32.html.

6. See FDA Exports and Imports Guidance, part VII.D.

7. See Center for Biologics Evaluation and Research, Export Certification: Submission Requirements for Requesting Certificates for Exporting Products to Foreign Countries, Food and Drug Administration, Dept. of Health and Human Services, available at www.fda.gov/cber/genadmin/expinstr.htm.

8. Certificates are issued pursuant to Section 801(e)(4) of the FDA Act, 21 U.S.C. § 381 (e)(4). See Office of Regulatory Affairs, Compliance Policy Guide, Section 110.100, Certification for Exports, Food and Drug Administration, Dept. of Health and Human Services, available at www.fda.gov/ora/compliance_ref/cpg/cpggenl/cpg110-100.html.