Hamburg calls for more FDA powers to ensure drug quality

13-Apr-2011 - Last updated on 14-Apr-2011 at 08:52 GMT

FDA Commissioner Hamburg has asked for more supply chain security and quality control regulatory powers.

Margaret Hamburg, Commissioner of the US Food and Drug Administration (FDA), was speaking at a House subcommittee meeting on import screening. Hamburg outlined progress made by the FDA and called on lawmakers to grant the agency regulatory powers to handle globalisation.

“New regulatory authorities may help ensure that we can hold industry accountable for the security and integrity of their supply chains and the quality systems they use to produce drugs”, said Hamburg. FDA powers should be, at a minimum, similar to its global counterparts.

Hamburg broke down the list of potential new powers into three categories: information sharing; enforcement; and corporate responsibility. Each power is, according to Hamburg, an important tool in efforts to ensure the safety of imports in a globalised operating environment.

Proposed enforcement tools include: express authority to address threats to US consumers, regardless of where they arise; refusal of admission if inspection is delayed, limited or denied; mandatory recall authority; and enhanced criminal and civil penalties.

Under the heading corporate responsibility Hamburg called for: adoption of a track-and-trace system; additional powers to make manufacturers account for quality of materials used in their products; and modernisation of its list of domestic and overseas production facilities.

Finally, Hamburg covered information sharing, asking for: foreign and domestic companies to provide information on threats, such as counterfeiting; unique facility identifiers to be a condition of registration and import; and authority to share non-public information with global counterparts.

The Drug Safety Enforcement Act, which Representative John Dingell continues to promote, includes some of these powers. Hamburg referred to Dingell in her speech and called for lawmakers to give the drug wing of the FDA its equivalent of the Food Safety Modernization Act.

PREDICT

Much of Hamburg’s speech focused on use of the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting application (PREDICT). Roll-out of the risk-based import tool has been delayed by technical issues but, with these resolved, it is being added to new districts.

Cliff Stearns, chairman, subcommittee on oversight and investigations, called on Hamburg to “push more aggressively”for PREDICT to be deployed immediately nationwide. With technical issues fixed Stearns asked why the FDA’s most promising tool is being deployed piecemeal.

PREDICT is currently used in Los Angeles, New York, Seattle and San Francisco. This month it will be implemented in Florida and San Juan, expanding coverage to 50 per cent of imports, and, if successful, will be rolled out nationwide.

Progress has been too slow for Stearns though. “At this rate, it would take FDA over 5 years to deploy PREDICT in the remaining 16 FDA districts”, said Stearns, who thinks the system should also be used at international mail and express couriers’ facilities.

“FDA cannot claim to be doing all it can to protect the American people from these threats so long as such a major entry-point for goods into the country remains largely unmonitored”, said Stearns.