A US Senator last week introduced the first significant piece of legislation addressing pharmacogenomics that if approved into law could have broad implications for the development of molecular diagnostics and targeted therapeutics.
Introduced by Illinois Senator Barack Obama last Thursday, the bill, entitled the “Genomics and Personalized Medicine Act of 2006,” would create a new federal agency to oversee personalized medicine. It would regulate the rate and scale of genomics research, physician education, incentives for developing genomic diagnostics and drugs, regulating genetic tests under the Clinical Laboratories Improvement Act, and overseeing genomic privacy and direct-to-consumer advertising. It would also create a tax credit for developers of certain companion diagnostic tests.
The bill contains provisions for $10 million to regulate the quality of genetic tests, including creating a genetic testing specialty under CLIA; and $30 million to regulate advertising for DTC genetic tests. The bill also encourages legislation of genetic privacy and non-discrimination.
“The entire bill itself will help expand pharmacogenomics,” Jennifer Leib, Affymetrix’ associate director for government relations and public policy, told Pharmacogenomics Reporter this week.
Ed Abrahams, executive director of the Personalized Medicine Coalition, said the bill “raises the profile of personalized medicine, underlining the fact that this paradigm requires new guidelines for regulation, reimbursement, privacy, and other concerns.”
However, it is still too early to say whether the bill has a chance of becoming law. There is no similar version in the House of Representatives, the bill has no co-sponsors in the Senate yet, and no hearings have been scheduled.
The bill can be read here
New Working Group
Perhaps the largest organizational component in the bill is the proposed creation of a Genomics and Personalized Medicine Interagency Working Group under the auspices of the US Department of Health and Human Services.
The IWG would be charged with expanding and accelerating genomics research and its translation into clinical and public health application, according to the text of the bill.
The new agency is intended to serve partly as a central source of information about pharmacogenomic programs, research, and recommendations from the DHHS, including the various US National Institutes of Health and the US National Academies of Science.
The IWG would be staffed by specialists from throughout the NIH, including the National Human Genome Research Institute, as well as the Centers for Disease Control and Prevention, the US Food and Drug Administration, the Centers for Medicare and Medicaid Services, and six other agencies. The DHHS secretary would serve as the IWG chair.
Meeting at least twice a year, the IWG would draft recommendations for the heads of federal agencies and accept public comment on its activities.
The IWG would be supported by a $5 million grant for 2007, followed by grants of undetermined amounts for subsequent years.
The bill also tries to breach one of the major barriers to the use of pharmacogenomics in the clinic: physician ignorance. And it calls for the appropriation of $10 million for 2007 to accomplish this goal, with subsequent years funded by additional appropriations.
The bill would require the DHHS secretary to work through the IWG, the CDC director, and the administrator of the Health Resources and Services Administration to “expand and intensify” efforts to recruit and retain health professionals in the genomics workforce, assess and recommend improvements to genomic training, and “develop a plan to integrate genomics into all aspects of health professional training.”
To recruit and retain trainees in genetics and genomics, the bill would require the DHHS secretary to provide “financial incentives, such as scholarships or loan repayment” and support for “genomics fellowships for medical and other health professional students,” as well as education and research opportunities. It also requires DHHS to consider variations of genomic subspecialty fellowships, concentrations, and programs.
The DHHS may also provide grants to recognized professional genetics and genomics societies and academic institutions to improve genomics training, and directly “assist” various accreditation organizations with genomics requirements.
The bill also supports integrating genomics into “all aspects of clinical and public health practice” through informational efforts that include health professional guidelines that explain administration and interpretation of genomic tests, especially for clinicians lacking the knowledge.
Tax Credits for PGx
Should the bill become law it would require a tax credit for developers of companion diagnostic tests. The requirement would be supported by $30 million in appropriations.
The bill “raises the profile of personalized medicine, underlining the fact that this paradigm requires new guidelines for regulation, reimbursement, privacy, and other concerns.”
The incentive serves a similar function as the extension of patent rights for orphan drugs. In fact, when an early version of the bill included extended patent rights, it “ruffled some feathers” among generic pharmaceutical companies, and the incentive was changed to the current credit, according to Robert Wells, vice president of corporate affairs at Affy.
The credit would be applied to research expenses incurred during the development of a qualified companion diagnostic test at the request of the DHHS secretary, according to the bill’s text.
Other qualifications exist, and the DHHS secretary can regulate how the credit is carried out, according to the bill.
The bill also calls for the National Academy of Sciences to study and recommend incentives for drug sponsors to develop companion diagnostics for new and existing drugs, as well as by unaffiliated diagnostics companies.
Expanding and Accelerating Research
The bill provides for the appropriation of $150 million for the secretary of the HHS to conduct studies of the genomic contribution to disease, drug response, and gene-environment interactions. Some of this amount is also intended for biobanking purposes and race, genomics, and health.
The funds would also be intended for population-based epidemiology studies; cost-effectiveness and cost-benefit analyses of pharmacogenomics; studies on the impact of genetic tests on population health; and methods to “enhance provider uptake.”
Dora Hughes, a spokesperson for Obama and his specialist on the bill, stressed that the timing of its introduction was not related to the July Senate Special Committee on Aging hearing concerning DTC nutrigenetic tests.
Beginning in January, Hughes reached out to several government agencies, patient advocacy groups, professional societies, and policy organizations to research and solicit comments for the bill.
Some of these included the American College of Medical Genetics, the Genetics and Public Policy Center, the National Association for Genetic Counselors, as well as the NIH and the CDC.
Asked what Senator Obama’s impetus was for focusing on pharmacogenomics and personalized medicine, Hughes said he had read several recent newspaper articles concerning the field, and recognized it represents a change in how medicine can be practiced.