Obama Precision Medicine Fuels Fire Over FDA's Plan For LDTs

January 30, 2015 at 5:25 PM
The White House revealed Friday (Jan. 30) that its 2016 budget will include $215 million for the president's new Precision Medicine Initiative, including $10 million for FDA to beef up its expertise and databases to support a new regulatory structure that both spurs innovation in precision medicine and protects public health. This effort could affect recent moves by FDA to regulate laboratory-developed tests (LDTs), especially genetic tests, as President Barack Obama said Friday the agency's reviews must reflect the difference...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.