NEW YORK (GenomeWeb News) - 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.
The agency would regulate the rate and scale of genomics research and physician education. Itb would also regulate 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 GenomeWeb News sister publication 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.”
The entire version of this article can be found in this week’s Pharmacogenomics Reporter, a GenomeWeb News sister publication.