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On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA), Public Law No. 110-85. The law, which reauthorizes legislation allowing FDA to collect user fees from drug and device manufacturers, contains a provision related to genetic testing quality. Sec. 1103 of the law, “Improving Genetic Test Safety and Quality,” states that should the Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) not complete by July 2008 a report and recommendations on genetic testing oversight requested last spring by the secretary of Health and Human Services, then the secretary shall enter into a contract for a study on the same topic with the Institute of Medicine. Sec. 1103 also contains a “rule of construction” stating that “Nothing in this section shall be construed as requiring Federal efforts with respect to regulatory oversight of genetic tests to cease or be limited or delayed pending completion of the report by the Secretary's Advisory Committee on Genetics, Health, and Society or the Institute of Medicine.”
The provision on genetic testing safety and quality originally was introduced by Sen. Barack Obama (D-Ill.) during deliberation on the Senate’s version of the bill. The Obama amendment would have required an Institute of Medicine (IOM) study irrespective of the timing of the SACGHS report. At the time, the Center expressed significant concerns with the amendment, arguing that an IOM study was unnecessary in light of the SACGHS’s current efforts, and that imposing a requirement for an IOM study could be used to delay legislative or regulatory efforts to improve oversight.
As enacted, the provision substantially addresses the Center’s concerns. Said Center Director Kathy Hudson, “We think Congress struck the right balance here by respecting the hard work that SACGHS is doing at the Secretary’s request, and by not halting federal efforts at a time of tremendous technological change. At the same time, the provision sends a strong message that we need to move expeditiously to improve genetic testing oversight and protect the public.” – Gail Javitt
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