FDA moves to limit producers’ influence

PHILADELPHIA – Food and Drug Administration officials unveiled new drug-safety rules Friday aimed partly at reducing the influence of drug-makers on certain FDA actions.

FDA official Steven Galson said members of the agency’s new Drug Safety Oversight Board will face stricter requirements. He contrasted the rule to current practice in which FDA advisory committee members – often outside experts – sometimes vote on a product even if they worked on it or took money from a manufacturer at some point.

Also, drug firms won’t be allowed in advance to edit or challenge safety data posted on the FDA’s new early warning system, called Drug Watch. Most risk-benefit data disseminated by the FDA now is based on warning labels negotiated by regulators and drug-makers. Drug Watch will include serious warnings even if they go beyond the labels.