Trade secret changes critical to regulatory sharing, FDA says
Globalisation of pharmaceutical manufacturing is driving closer collaboration between regulators but sharing is limited by legislation. For collaborative efforts to fulfil their potential the US Food and Drug Administration (FDA) thinks legislators must remove these barriers.
“It’s critical to be able to share information with regulatory partners if we want to take advantage of their regulatory reach and be as efficient as possible”, Peter Beckerman, senior policy advisor at the FDA, said during a Congress subcommittee hearing to discuss generic and biosimilar user fees.
Provisions of the Food, Drug, and Cosmetic Act prevent the FDA from sharing information classed as trade secrets. The information the FDA wants to share is not “the secret formula for Coke”, Beckerman said, but relates to pharmaceutical manufacturing processes.
Beckerman told the Congress subcommittee legislation to allow the FDA to share information about manufacturing processes with its regulatory partners would be “very helpful”. By sharing information with other regulators the FDA hopes to improve global supply oversight by cutting duplicated efforts.
In its generic drug user fee act (GDUFA) proposal, which Beckerman was at Congress to discuss, the FDA outlined plans for using more inspection information gathered by foreign regulators.
Beckerman listed other areas the FDA wants more power. In some cases foreign manufacturers have prevented FDA inspectors from taking a thorough look at their facilities. New powers are needed to stop this happening.
“Having an explicit authority to allow us to exclude a drug if our inspectors have been impeded would be extremely helpful”, Beckerman said. Currently there is “no immediate recourse” the FDA can take.
Companies have an“incentive to let FDA inspectors in for pre-approval inspections”, Beckerman said, but once a drug is on the market this motivation no longer exists. In these cases a different tool, such as the power to pull a drug from the market, is needed to encourage manufacturers to comply.