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Obama Added IoM Study to FDA Revitalization Act to Reach Consensus on Gene Dx Oversight

The lack of consensus regarding the oversight of genetic tests compelled Illinois Senator Barack Obama to introduce an amendment to the pending FDA Revitalization Act of 2007 that would contract the Institute of Medicine to study and recommend how federal regulation of genetic tests might be improved, according to a statement from Obama’s office.  
“Although issues relating to genetic test regulation have been studied extensively over the past decade, no high-level consensus has been reached on an actual regulatory framework for genetic tests,” a spokesperson from Obama’s staff told Pharmacogenomics Reporter last week.
Obama’s amendment to the bill would allocate federal dollars to study the safety of genetic tests. Critics claim the amendment is superfluous.
For instance, Johns Hopkins University’s Genetics and Public Policy Center Director Kathy Hudson, recently wrote in the center’s newsletter that earlier studies investigating the genetic testing market have already concluded that additional oversight of the industry is necessary, and that launching another investigation would misappropriate federal investment and foster government inaction [see PGx Reporter 06-06-2007].
During the Drug Information Association’s annual meeting in Atlanta this week, Dora Hughes, legislative aid to Obama on health and education issues, said that the proposal for the IoM study, also outlined in Obama’s “Genomics and Personalized Medicine Act,” has been “accepted as an amendment to FDA’s reauthorization act, which has passed the Senate and is going to the House right now.” The reauthorization bill will likely be voted on in July or early August, she said.
Whether attaching the amendment to the FDA reauthorization bill would increase the proposal’s chances of passage was unclear. Obama’s staff did not respond to requests for comment on that particular matter.
According to Hughes, the confusion between FDA oversight and the Centers for Medicare and Medicaid’s existing CLIA regulations was a major point of contention in the comments she received on Obama’s “Genomics and Personalized Medicine Act of 2007” (see related story, this issue).
For the more than 1,000 genetic tests developed and marketed by independent laboratories as homebrew tests, very few have been cleared by the FDA, a spokesperson from Obama’s staff noted.
The Obama amendment “provides for a study conducted by the [IoM] to make recommendations on how to improve Federal oversight and regulation of genetic tests — whether through FDA regulation or enforcing CLIA — to ensure the safety and quality of genetic tests and to increase information about such tests for patients and providers,” the spokesperson stated.  
With regard to the regulations of certain algorithm-based tests, called in vitro diagnostic multivariate index assays, the confusion regarding CMS/FDA oversight is particularly palpable. At FDA’s public meeting in February for IVDMIAs, laboratory test developers expressed confusion about how FDA oversight would dovetail with CLIA regs, and criticized that FDA regulation would stifle innovation [see PGx Reporter 02-14-2007].  

“The recent draft guidance issued by the FDA on In Vitro Diagnostic Multivariate Index Assays underscores the complexity and difficulty of creating such a framework.”

The FDA’s recent draft guidance on IVDMIAs “underscores the complexity and difficulty of creating such a framework,” Obama’s spokesperson said.
“The IVDMIA guidance was met with major opposition by both industry and patient advocacy groups,” the spokesperson added. “Senator Obama believes the independent and well-regarded IOM should be involved in this effort and his staff has begun discussions with the IOM leadership in this regard.”
While the GPPC feels that another IoM study would foster government inaction, the center does feel that Congress can play a role in ensuring the safety of genetic tests by requiring CMS to create a genetic specialty.
Obama’s personalized medicine bill (S.976) does propose the creation of a genetic specialty within CMS for molecular and biochemical genetic tests that do not require premarket approval or notification by the FDA.
The specialty area, the bill says, would develop criteria for establishing analytic and clinical validity for the tests that fall under CMS’ jurisdiction by an IoM-recommended “decision matrix.” The genetic specialty proposed by the bill would also make publicly available information about laboratory certifications and the clinical validity of marketed genetic tests, as well as specify proficiency testing requirements for labs.
“Many have voiced concerns that the regulations under CLIA aren’t strong enough or aren’t enforced well enough,” Hughes said during the DIA meeting. Last year, three nonprofit organizations, including the GPPC, the Genetic Alliance, and Public Citizen filed a Citizen Petition asking CMS to strengthen its oversight of genetic tests by creating a genetic testing specialty [see PGx Reporter 09-27-2006].
According to GPPC, CMS has yet to respond to the petition. However, a CMS official recently said that the agency has not created a genetic testing specialty because it will not provide clinical validity; solve proficiency testing and quality control issues; address the ethical, legal, and social implications of genetic testing; or tackle direct-to-consumer marketing issues. [see PGx Reporter 06-13-2007].
GPPC has also “advocated for a more coherent oversight system for genetic tests, one that eliminates the current ‘two-path system’ that imposes vastly different oversight on lab-developed tests and ‘test kits,’” Gail Javitt, the center’s director of law and policy, said in an e-mail to Pharmacogenomics Reporter this week.

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