Illinois Senator and Democratic presidential candidate Barack Obama recently introduced an amendment to the pending Prescription Drug User Fee Amendments of 2007 (S. 1082)that would allocate federal funds to study the safety of genetic tests.
But according to Johns Hopkins University’s Genetics and Public Policy Center, earlier studies investigating the genetic testing market have already concluded that additional oversight of the industry is necessary, and that launching another investigation would be superfluous, misappropriate federal investment, and foster government inaction.
“Requiring yet another study to reach this same conclusion is a poor use of resources and an unnecessary delay to taking real and meaningful action to protect public health,” GPPC Director Kathy Hudson wrote in the most recent issue of the center’s newsletter.
GPPC Director of Law and Policy Gail Javitt told Pharmacogenomics Reporter this week that while the center doesn’t have a position on how better to use PDUFA funds, Congress does have a role to play in improving the safety of genetic tests.
According to Javitt, Congress should enforce CMS to strengthen its oversight of genetic tests.
“On the issue of CMS providing an adequate level of oversight for laboratories doing genetic testing, CMS has all the authority to do what they need to do, [but] they are just not doing it,” said Javitt. Congress has the authority to “direct a recalcitrant agency to act within its existing jurisdiction.”
Currently there are two bills under consideration in Congress: Obama’s “Genomics and Personalized Medicine Act of 2006” and Senator Edward Kennedy’s (D-Mass.) “The Laboratory Test Improvement Act.” Both bills would increase federal oversight of genetic tests.
With legislation pending that already covers the safety of genetic tests, Obama’s PDUFA amendment perhaps appears even more gratuitous to GPPC. However, Obama may have introduced the amendment to politically align himself closer to Kennedy, who chairs the Health, Education, Labor and Pensions committee, which has jurisdiction over the Personalized Medicine Act.
GPPC’s Hudson previously suggested to Pharmacogenomics Reporter that Obama’s bill would have a better chance of passing if he aligned closely with the issues outlined in Kennedy’s Laboratory Test Improvement Act [see PGx Reporter 11-21-2006]. An Obama/Kennedy alliance would put more political muscle behind the Illinois Senator’s bill.
Obama’s office did not return requests for an interview prior to deadline.
‘Paralysis by Analysis’
Obama’s PDUFA amendment, which was passed in the Senate and is being reviewed in the House, seeks to use PDUFA dollars to fund an IoM report on the safety of genetic tests.
The amendment to the bill, S. 1082, states:
"Not later than 30 days after the date of enactment of this Act, the Secretary [of HHS] shall enter into a contract with the Institute of Medicine to conduct a study to assess the overall safety and quality of genetic tests and prepare a report that includes recommendations to improve Federal oversight and regulation of genetic tests. Such study shall take into consideration relevant reports by the Secretary's Advisory Committee on Genetic Testing and other groups and shall be completed not later than 1 year after the date on which the Secretary entered into such contract."
The amendment “is troubling” to the GPPC, because it seems that yet another report on an already heavily studied issue would not add anything new to the body of knowledge regarding the safety of genetic tests, but would only appease those who are against greater oversight of genetic tests.
“Given the rapid pace with which new genetic tests are entering the market, it is a dangerous time to be tying the federal government’s hands,” Hudson said in the GPPC’s newsletter. “Paralysis by analysis, however, seems to be the motivation of some who support this amendment.”
In GPPC’s view, another IoM report may be redundant since the institute has already looked into the matter. In a 1994 report titled Assessing Genetic Risks: Implications for Health and Social Policy, the IoM found that CMS and then US Food and Drug Administration needed to provide greater oversight of genetic tests to ensure their safety and effectiveness.
Similar recommendations came in 1997 from the National Institutes of Health’s Department of Energy Task Force on Genetic Testing report, called “Promoting Safe and Effective Genetic Testing in the United States,” and again in 2000 from the HHS Secretary’s Advisory Committee on Genetic Testing release, entitled “Enhancing the Oversight of Genetic Tests: Recommendations of the SACGT.”
Most recently, on March 23 HHS Secretary Michael Leavitt unveiled the Personalized Health Care Initiative, which requires the Secretary’s Advisory Committee on Genetics, Health and Society to report on the accuracy, validity, and usefulness of genetic tests. The HHS report will likely be released by the end of this year, Javitt said.
“On the issue of CMS providing an adequate level of oversight for laboratories doing genetic testing, CMS has all the authority to do what they need to do, [but] they are just not doing it.” Congress has the authority to “direct a recalcitrant agency to act within its existing jurisdiction.”
“Over the past decade there have been several government groups assigned to look at this specific issue and they have consistently come back saying that there needs to be strengthened oversight by CMS and FDA,” Javitt said. “So it’s hard to see what one more report is going to actually add to the issue.”
In the GPPC newsletter, Hudson suggested that groups opposed to stronger regulations for tests will just use this additional report as an excuse to delay real action on the issue.
“Those opposed to changes in genetic testing oversight will likely use the pending IoM report to call for delay of any legislative or regulatory actions to improve oversight,” Hudson said. “The amendment offers the appearance of doing something to improve oversight, while distracting attention from real and pressing concerns.”
CMS Refuses to Act
In the GPPC newsletter, Hudson notes that although CMS has the authority under the Clinical Laboratory Improvement Amendments of 1988, the agency has “refused to act.”
“A clear directive from Congress could break this impasse,” she wrote. “While both HHS and the pharmaceutical industry have heralded the advent of ‘personalized medicine’ as a means to provide tailored treatment based on genotype, this endeavor will fail if health care providers and the public do not have confidence in the genetic tests used to make treatment decisions.”
Last summer the GPPC and the Genetic Alliance filed a Citizen Petition with CMS requesting that CLIA regs be strengthened by creating a genetic specialty. “We have not received a response nearly six months later,” Javitt had noted in February during the FDA’s public meeting on in vitro diagnostic multivariate index assays.
Another confounding issue is the FDA’s recent suggestion that it, and not CLIA, should regulate certain laboratory-developed algorithm-based developed tests, so-called IVDMIAs. However, during the public meeting there was much confusion among laboratory test developers regarding how existing CLIA regulations under CMS would dovetail with FDA’s authority [see PGx Reporter 02-14-2007].
Under the CLIA statute, CMS ensures that tests are analytically valid. Meanwhile, FDA makes sure that tests are clinically meaningful. However, FDA oversight is currently limited to only genetic test kits, Javitt pointed out.
"There is a huge disparity in regulatory requirements depending on how the laboratory does the genetic testing," she said. Javitt added that although CMS is responsible for ensuring the analytical validity of tests, one way that the FDA can uphold public health is by developing a registry of marketed genetic tests and making the clinical data regarding their safety and efficacy publicly available.
Javitt noted that although Obama’s PDUFA amendment is superfluous, the fact that the safety of genetic tests has been examined at so many times signals their growing importance in health care and with the public.
The issue has been "looked at several times because genetic tests are becoming more and more a part of medical care," she said. "There has been an explosion in the number of genetic tests in the past decade. So, there has been an appropriate realization that a lot of things have to come together for us to realize the benefit of genetic testing."