Promotion of Genetic Testing Services Directly to Consumers
Currently, there are more than 1300 genetic tests clinically available, more used in research, and even more in various stages of development. Most often, individuals receive genetic testing services from their healthcare providers, providers who may or may not be trained in genetics. Although most clinical tests are offered through traditional means (e.g. healthcare providers), some genetic tests are now available directly to the consumer via the Internet. The direct-to-consumer promotion of genetic tests is one of two distinct public policy issues, the other being the overall quality of genetic tests.
Once genetic tests are regulated and their safety and accessibility ensured, direct-to-consumer marketing of those tests could be acceptable for some tests. When paired with appropriate information and support, genetic tests can provide consumers with essential information about their health and the health of their families.
Current law restricting the promotion of genetic tests and services:
Today, the promotion of genetic tests and services to consumers is restricted in a number of different ways:
- The Food and Drug Administration (FDA), via the Federal Food, Drug, and Cosmetic Act, has the authority to regulate prescription drug advertisements.
- The Federal Trade Commission (FTC), via the Federal Trade Commission Act, has the authority to regulate over-the-counter drug marketing.
- Commercial speech is protected by the First Amendment, which states that, “Congress shall make no law… abridging the freedom of speech, or of the press.” Historically, the courts have ruled that “only speech that is truthful and relates to lawful activity merits First Amendment protection;” that government must “demonstrate that it has a substantial interest in restricting the speech at issue;” that “the restriction must directly advance the state interest involved,” and that the “restriction must not be more restrictive than necessary to achieve the governmental interest.”
Benefits of direct-to-consumer marketing of genetic tests:
- The direct-to-consumer marketing and sale of genetic tests increases the likelihood that an individual will have access to a particular genetic test.
- The rising number of genetic tests and our expanding genetics knowledge have, over the past 10 years, made it increasingly difficult for healthcare providers to provide access to the genetic tests and services that many consumers need. In many cases, healthcare professionals simply do not know what tests are available or how their patients might benefit from those tests.
- Direct-to-consumer access to testing would allow consumers to take a proactive role in their healthcare.
- President Bush signed the Genetic Information Nondiscrimination Act (GINA) into law on May 21, 2008. The law provides individuals with federal protections against genetic discrimination in health insurance and employment. The health insurance provisions of the bill, Title I, will take effect 12 months after the date of signing, on May 21, 2009. The protections in employment, Title II, will take effect 18 months after the date of signing, on November 21, 2009. Until GINA is in full effect, the direct-to-consumer marketing and sale of genetic tests and services provides consumers with the privacy and security they desire.
Risks associated with the promotion of genetics tests directly to consumers:
- Genetic test results are complex and difficult to understand. Consumer’s face significant danger when tests are not offered, administered, and analyzed in a traditional medical environment with the appropriate genetic counseling services.
- Genetic test results can have implications that touch whole families and generations of individuals; as such, these results should be treated as sensitive medical information, offered only in a traditional medical environment.
Additional Resources and Information
