FDA SETS ITS PRIORITIES FOR DRUG SAFETY DEBATE IN NEXT CONGRESS
In its first major announcement since the midterm elections gave control of the next Congress to the Democrats, the FDA outlined what it believes should be the priorities to improve drug safety without sacrificing innovation. This comes as a leading lawmaker prepares to outline his recommendations for the agency.
The agency is afraid that in the rush to improve drug safety, Congress will overlook the importance of innovation, Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs, said in prepared remarks to be given to the Manhattan Institute Nov. 13. "I am deeply concerned that some of the ideas that have been discussed in broader policy circles for improving on drug safety measures will do little to make our drugs safe, but will do a whole lot to limit access to needed medicines and to slow down the development of new innovations," Gottlieb said.
Lawmakers have decried the agency's handling of drug safety issues and have pledged to implement policies improving that through legislation and implementation of an Institute of Medicine report's recommendations.
On the same day Gottlieb was to give his speech, Sen. Mike Enzi (R-Wyo.), the outgoing chairman of the Senate Health, Education, Labor and Pensions Committee, announced a slate of witnesses for his Nov. 16 hearing on ways to improve drug safety and innovation. The hearing is meant to help pass Enzi's and Sen. Edward Kennedy's (D-Mass.) bill, the "Enhancing Drug Safety and Innovation Act," and was originally announced last week.
There needs to be greater focus on the science of how drug safety programs are improved, Gottlieb said. "We need to improve the information that the agency receives," including spontaneous reports from sponsors and advisers, along with access to epidemiological data sets, he said.