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A regulatory patchwork [United States]

In the United States, there is no uniform or comprehensive system for the regulation of assisted reproductive technologies, including reproductive genetic testing. The federal government does not have direct jurisdiction over the practice of medicine. Moreover, it has banned all federal funding for research involving the creation or destruction of embryos. Consequently, the regulatory framework for reproductive genetic testing in the United States is characterized by a patchwork of federal and state regulation. Professional self-regulation also plays a central role in the governance of this field. Federal oversight of these technologies is spread among several agencies, whose jurisdiction in the area of assisted reproductive technologies and genetic testing is derived from existing statutes having broader applicability.

Clinical Laboratory Improvement Amendments of 1988 (CLIA): All laboratory tests performed for the purpose of providing health information to an individual must be conducted in laboratories certified under CLIA. CLIA requires the government to certify all laboratories performing testing to provide “information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.” Tests are regulated according to their level of complexity: waived, moderate, or high complexity. The regulatory requirements applied to these laboratories increase in stringency with the complexity of the test performed. Under CLIA, the Health Care Financing Administration’s (HCFA) Division of Laboratory Systems develops standards for laboratory certification. However, CLIA has no specific jurisdiction to regulate such aspects of genetic tests as clinical validity and utility, informed consent, or the provision of genetic counseling. Moreover, the Centers for Medicare and Medicaid Services (CMS), which administers CLIA, has taken the position that laboratories that perform PGD are not considered “clinical laboratories” under CLIA.

Food and Drug Administration (FDA): Under the Federal Food, Drug and Cosmetic Act, in vitro diagnostic products, i.e., products used to diagnose a disease or condition, are regulated as medical devices by FDA. However, not all products used by clinical laboratories to perform genetics testing are regulated as in vitro diagnostic products. In fact, FDA has limited oversight over the majority of tests used in PGD because many genetic laboratories develop their own tests, and these “home brews” are not generally under FDA’s purview. Furthermore, FDA does not have the authority to regulate the practice of medicine, leaving significant discretion to physicians as to how to use FDA-regulated products. FDA also has authority to regulate certain aspects of human tissue, but it is unclear whether and to what extent tissues used in PGD could be under FDA jurisdiction, and thus subject to pre-market review.

Centers for Disease Control and Prevention (CDC): The 1992 Fertility Clinic Success Rate and Certification Act (FCSRCA) requires that the Secretary of Health and Human Services (HHS), through the CDC, develop national reporting guidelines for ART. The Act also requires the Secretary to develop a model program for the certification of embryo laboratories to be carried out voluntarily by interested states. Under the Act, all clinics providing IVF services are required to report pregnancy success rates annually to the federal government. The CDC is in charge of analyzing the data and making it available to the public. However, the Act does not require clinics to report the use or outcome of PGD.

Office for Protection from Research Risks (OPRR): An additional level of oversight is provided during the research phase of genetic testing, but only when the research involves human subjects or identifiable samples of DNA. Regulations governing the protection of human research subjects are administered by the OPRR and FDA. OPRR oversees the protection of human subjects in all research funded by HHS, while FDA oversees the protection of human research subjects in trials of investigational devices, drugs, or biologics being developed for eventual commercial use.

As mentioned above, regulation of the practice of medicine involving PND and PGD falls to state laws or professional guidelines. To date, no state has adopted laws directly addressing PGD and PND, leaving researchers and clinicians to voluntarily abide by guidelines established by professional organizations.

In addition, several advisory bodies have reviewed the oversight of reproductive genetic testing in the United States and have made recommendations for improvement (Genetics and Public Policy Center, 2004 and President’s Council on Bioethics, 2004).

The American Society for Reproductive Medicine (ASRM) has provided oversight of PGD through various opinion statements. The ASRM believes that “PGD should be regarded as an established technique with specific and expanding applications for standard clinical practice.” ASRM also states that, while the use of PGD for the purpose of preventing sex-linked diseases is ethical, the use of PGD solely for sex selection is “discouraged.”

In turn, the American College of Obstetricians and Gynecologists has adopted best practice guidelines and opinions on the regulation and clinical practice of PND.

Further reference:

  • Ethics Committee of the American Fertility Society, The Biologic Characteristics of the Preembryo. Ethical Considerations of Assisted Reproductive Technologies, 62 (Suppl 1) Fertil Steril S29–S31 (1994).

  • Ethics Committee of the American Fertility Society, Quality Assurance in Reproductive Technologies. Ethical Considerations of Assisted Reproductive Technologies,) 62 (Suppl 1) Fertil Steril S81–S84 (1994).

  • College of American Pathologists, Standards for Laboratory Accreditation. Reproductive Laboratory Accreditation Program, (1997).

  • Practice Committee of the American Society for Reproductive Medicine, Elements To Be Considered In Obtaining Informed Consent For ART,
    (released January 1998), 82 (Suppl 1) Fertil Steril S202-3 (2004).

  • Implementation of the Fertility Clinic Success Rate and Certification Act of 1992—A Model Program for the Certification of Embryo Laboratories, 64 Fed. Reg. 39374, (July 1999).

  • American Academy of Pediatrics, Fetal Therapy—Ethical Considerations, (May 1999).

  • Federal Food, Drug and Cosmetic Act of 1938, 21 U.S.C. §§ 301–399 (2000).

  • American College of Obstetricians and Gynecologists, Practice Bulletin: Clinical Management Guidelines for Obstetrician-Gynecologists. Prenatal Diagnosis of Fetal Chromosomal Abnormalities, 97 (5 Pt 1) Obstet Gynecol (Suppl 1-12), (May 2001).

  • U.S. Department of Health and Human Services, Additional DHHS Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research, Code of Federal Regulations 45, (2002), pp. §§46.401–§§49.401.

  • Practice Committee of the American Society for Reproductive Medicine, Revised Minimum Standards for Practices Offering Assisted Reproductive Technologies, (adopted 2001), 82 (Suppl 1) Fertil Steril S4-7, (2004).

  • American College of Obstetricians and Gynecologists, Technology Assessment in Obstetrics and Gynecology. Genetics and Molecular Diagnostic Testing. Obstet Gynecol 100(1):193-211, (July 2002).

  • Human Cells, Tissues, and Cellular and Tissue-Based Products Rule, 21 C.F.R. §§ 1271.1–1271.20, (2004).

  • Establishment Registration and Listing Rule, 21 C.F.R. §§ 1271.21–1271.37, (2004).

  • American College of Obstetricians and Gynecologists, Committee on Ethics. Ethics in Obstetrics and Gynecology: Sex Selection, (2007).

  • Ethics Committee of the American Society for Reproductive Medicine, Preconception Gender Selection for Nonmedical Reasons, 82 (Suppl 1) Fertil Steril S232-5, (September 2004).

  • Practice Committee of the American Society for Reproductive Medicine, Guidelines for Advertising by ART Programs, approved May 2004, 82 Fertil Steril 527-8, (August 2004).

  • American Society for Reproductive Medicine and Society for Assisted Reproduction Technology Practice committees, Preimplantation Genetic Diagnosis, 82 (Suppl 1) Fertil Steril S120– S122, (2004).

  • American College of Medical Genetics, Prenatal Screening for Open Neural Tube Defects, Technical Standards and Guidelines for 2004, 7:5 Genet Med 355-369, (2005).

  • American College of Medical Genetics, Second Trimester Maternal Serum Screening for Fetal Open Neural Tube Defects and Aneuploidy, (2004).

  • American College of Obstetricians and Gynecologists, Committee on Genetics, (ACOG Committee Opinion Number 298), Prenatal and Preconceptional Carrier Screening for Genetic Diseases in Individuals of Eastern European Jewish Descent 104:2 Obstet Gynecol 425-8, (August 2004).

  • American College of Medical Genetics, Prenatal Screening for Down Syndrome, Technical Standards and Guidelines for 2004 Genet Med 7:5 344-354, (2005).

  • American Society for Reproductive Medicine, 2004 Compendium of ASRM Practice Committee and Ethics Committee Reports, 82 (Suppl 1) Fertil Steril S1–262, (2004).

  • American College of Obstetricians and Gynecologists, (ACOG Committee Opinion Number 297), Nonmedical Use of Obstetric Ultrasonography 104:2 Obstet Gynecol 423-4, (August 2004).

  • American College of Obstetricians and Gynecologists, Committee on Obstetric Practice, (ACOG Committee Opinion Number 304), Prenatal and Perinatal Human Immunodeficiency Virus Testing: Expanded Recommendations 104 (5 Pt 1) Obstet Gynecol 1119-24, (November 2004).

  • American College of Obstetricians and Gynecologists, (ACOG Committee Opinion Number 296), First-Trimester Screening for Fetal Aneuploidy 104:1 Obstet Gynecol 215-7, (July 2004).

  • Baruch S, Javitt G, Scott J, and K Hudson, Reproductive Genetic Testing: Issues and Options for Policymakers, (2004).

  • Hudson K, Scott J, Baruch S, and G Javitt, Preimplantation Genetic Diagnosis: A Discussion of Challenges, Concerns, and Preliminary Policy Options Related to the Genetic Testing of Human Embryos, (2004).

  • Fertility Clinic Success Rate and Certification Act of 1992, §§ 2–7, 42 U.S.C.S. §§ 263a-1–263a-7, (2005).

  • Medical Devices Rule, 21 C.F.R. § 809.10(e), (2005).

  • Classification/Reclassification Rule, 21 C.F.R. § 809.30, (2005).

  • President’s Council on Bioethics, Reproduction and responsibility: the regulation of new biotechnologies, (2004).

  • American College of Obstetricians and Gynecologists, Committee on Genetics, (ACOG Committee Opinion Number 325), Update on Carrier Screening for Cystic Fibrosis, 106:6 Obstet Gynecol 1465-8, (December 2005).

  • American College of Obstetricians and Gynecologists, Committee on Genetics, (ACOG Committee Opinion Number 338), Screening for fragile X syndrome, 107:6 Obstet Gynecol 1483-5, (June 2006).

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