By: Maureen Kingsley

 

Javitt

Terry

A letter to HHS Secretary Kathleen Sebelius from both the Genetics and Public Policy Center of Johns Hopkins University (Washington, DC) and the Coalition for 21st Century Medicine (Arlington, VA) urges the secretary to make oversight of advanced diagnostic tests a priority during her tenure. The letter, dated April 30, 2009, and remarkable for its 108 signatories, implores Secretary Sebelius and HHS to “create and implement a reasonable and responsible regulatory framework” for genetic tests and other advanced medical diagnostics, in order to “get personalized medicine right.”

The letter notes that advanced diagnostic testing that helps determine whether an individual patient is likely to benefit from treatments for his or her condition is “at the core” of personalized medicine.

Arguing their position that regulatory oversight of diagnostic innovations must strike the right balance between assuring patient safety and “embracing policies that encourage the incorporation of rapidly advancing scientific methods and knowledge,” the writers outline three recommendations they would like to see HHS follow in the near future. The first is implementing risk-based oversight of all advanced diagnostics, including IVD test kits and laboratory-developed tests. The second is posting a publicly accessible, searchable, online registry of names of labs that perform a specific test, the name of the manufacturer of the test, and information to support claims about the analytical and clinical validity of that specific test or method. The third is strengthening CLIA oversight of clinical laboratory quality systems.

Sharon Terry of Genetic Alliance (Washington, DC), a board member of the Coalition for 21st Century Medicine and one of the drafters of the letter, calls the creation of the recommended online registry “a very simple thing to do” and the suggestion that would likely be the least difficult to implement. She points out that the required technology already exists at the National Center for Biotechnology Information (Bethesda, MD), the group responsible for PubMed and The Cancer Genome Anatomy Project.

According to Gail Javitt, law and policy director for the Genetics & Public Policy Center, dissatisfaction with the state of genetic and advanced-diagnostic testing regulation in the United States has existed for some time. “The current oversight of the tests is not good for the public in terms of ensuring the quality of the tests and also not good for industry, in terms of having a fair and clear pathway for developing the tests,” she says. This concern about inadequate regulation came to a head in the previous administration, Javitt says, and then-Secretary Leavitt asked the Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) to look into the matter. SACGHS did, and it issued a report in April 2008 noting gaps in the current oversight process, confirming that those gaps are problematic, and recommending that fixes be put into place. The then-secretary did not initiate any policy changes in response, and the problems persist.

“The changing of the guard provided a good opportunity for renewing attention to these concerns,” Javitt says of the timing of the letter, but she says she “has no way to know” whether Secretary Sebelius will be more receptive to and proactive regarding these concerns. Terry has had no personal contact with Secretary Sebelius either but says that her very general sense is that the secretary agrees that progress needs to be made in healthcare and that diagnostics are a part of that.

As for whether the groups behind the letter plan any follow-up, Javitt says she suspects they do, though she's uncertain what form it will take. Terry says that follow-up to these kinds of communiqués typically include contacting the secretary's office and asking for a personal meeting with her or her deputy. She says such a meeting might include other individuals from the administration or additional agencies.

The 108 signers of the letter comprise a diverse collection of parties interested in personalized medicine. These include laboratories that develop advanced diagnostics, physicians, investors, and patients and their advocates. Terry says that the Coalition for 21st Century Medicine has a “really broad reach and great participation” in its endeavors because the group invests a lot of time beforehand educating the community via webinars, meetings, e-mail, and white papers. The Coalition itself represents a wide spectrum of groups, including diagnostic tech companies, clinical laboratories, researchers, patient groups, and venture capitalists.

A copy of the letter is available at www.dnapolicy.org/resources/LtrtoSecSebeliusrePersonalizedMedicine.pdf.