FDA asks for powers to stop another heparin-like crisis

14-Sep-2011 - Last updated on 15-Sep-2011 at 07:50 GMT

The FDA needs additional powers to update its “antiquated, domestically-focused statute” and end the “competitive advantage of non-compliance”, an agency official said.

Criticisms of the gap between US Food and Drug Administration (FDA) powers and the capabilities it needs to police the supply chain were heard by lawmakers at a US Senate Committee yesterday.

“The FDA needs the ability to refuse import of products from facilities that have delayed or denied regulatory inspections”, Deborah Autor, deputy commissioner for global regulatory operations and policy, FDA, told the committee.

Currently the FDA must show that a product appears to be adulterated, misbranded or unapproved to be granted an import ban. Making this argument each time the FDA has problems inspecting an overseas facility is costly and time-consuming, Autor said, and the process could be simplified.

Legislation from congress could help streamline the process but some members of the bipartisan panel questioned the need for more powers. “Right now my concern is FDA over-regulating, not FDA under-regulating”, Michael Enzi, Republican Senator for Wyoming, said

However, all doubted the likelihood of more funds in the current climate so legislation and better use of resources were discussed by Autor. In written remarks and a question and answer session Autor repeatedly highlighted areas of weakness at the FDA that congress could correct.

The Senators listened with a view to helping improve the situation. “We’re seeking information…to come up with the best formula that we’re going to put in the PDUFA (prescription drug user fee act) reauthorisation next year”, Tom Harkin, Democratic Senator for Iowa, said.

Additional powers

Currently the FDA lacks the authority to need assurance of compliance for imports and, Autor said, this places the burden on the agency. Instead, Autor said the onus should be on the importer to show a drug complies with US regulations.

Autor also asked for greater powers to tackle quality problems at the source. To inspect facilities in China US-based FDA employees need a letter of invitation from the company to get a visa. This makes unannounced inspections very difficult and Autor would like the situation to improve.

Having a clearer record of all plants supplying the US would also help and Autor wants unique facility identifies, ideally harmonised across regulatory agencies, to be an import requirement. A mandatory track-and-trace system would also help, Autor said, although Senators were concerned about costs.

Despite differences there was agreement. “I find remarkable the degree of consensus around a lot of the issues we face”, Michael Bennet, Democratic Senator for Colorado, said. The consensus, Bennet said, is a result of the gap between legislation and reality, and its potentially deadly consequences.

“[Another heparin-like crisis is] not a matter of if, it’s a matter of when”, Autor said.