SPONSORS PLAY CRITICAL ROLE IN LABELING REVISIONS, FDA OFFICIAL SAYS
As lawmakers push legislation that would give the FDA the authority to mandate changes to drug labeling, one top agency official argues that sponsors play an essential role in crafting the most comprehensive labeling possible.
Under the current system, in which the FDA negotiates labeling changes with pharmaceutical firms, sponsors are able to provide useful data that help improve the quality of the information the agency makes available in labels, said Scott Gottlieb, who recently returned to the FDA as its deputy commissioner for medical and scientific affairs after a stint at the American Enterprise Institute (AEI).
"If there isn't some kind of framework to have that discussion, there is a risk that some information might not become available in the way that it does now," Gottlieb told FDAnews.
Gottlieb, who has been on the job at the FDA for only a few weeks, said he was still getting up to speed on various agency positions and declined to comment on specific legislative proposals. But as an AEI resident fellow, he clearly pointed out the pitfalls of giving the FDA the authority to dictate labeling information.
The labels that the FDA writes sometimes aren't very good, he told the Senate Health, Education, Labor, and Pensions Committee at a March hearing on the drug approval process. If Congress is going to give the FDA the power to mandate label changes, at the very least it should include a robust appeals mechanism so that when sponsors have critical information, or valid points to make, they can make them, Gottlieb told the lawmakers.
In general, Gottlieb supports opening lines of communication with industry in many ways. "Anything that we can do, and the drug companies can do, to try and have earlier discussions around products -- particularly around novel products -- can really help improve the process for not only developing them, but also for developing good information that we can then make available to doctors and patients around using those products," he said in the interview.