Drug and food safety trump jobs, say FDA's Hamburg, other regulators

FDA chief Margaret Hamburg speaks with counterparts from Health Canada, Paul Glover (left), and the European Medicines Agency, Guido Rasi, at the Convention Center. ELISE WRABETZ / Staff Photographer
FDA chief Margaret Hamburg speaks with counterparts from Health Canada, Paul Glover (left), and the European Medicines Agency, Guido Rasi, at the Convention Center. ELISE WRABETZ / Staff Photographer
Posted: June 26, 2012

The economic turmoil in much of the industrialized world has affected the drug industry, but regulatory leaders from the United States, Canada, and Europe said Monday that safety and science must not be compromised for the sake of jobs that might be created if rules were relaxed.

"We all live in a world where there are important politics that pound at the door," said Margaret Hamburg, commissioner of the U.S. Food and Drug Administration. "Science must be the critical tool that guides us in our decision making."

Hamburg joined Paul Glover of Health Canada and Guido Rasi of the European Medicines Agency in a panel discussion about international regulatory collaboration at the Drug Information Association's 48th annual meeting at the Convention Center.

Some members of Congress say the FDA has not done enough to create jobs, ignoring the fact that the agency's mission is to ensure the safety of food and drugs. The FDA was recently criticized for having contributed to the problem of drug shortages, with the evidence being an increase in warning letters, which come from inspections that find manufacturing problems.

Plant shutdowns to fix problems have been one cause of shortages, most of which are with sterile injectable drugs that are complicated to make. Hamburg noted that most of the increase in warning letters was related to tobacco — the regulation of which was given to the FDA three years ago.

"They are not quality issues anyone would want the FDA or other regulators to look the other way on — glass shards, metal fractures, contaminants," Hamburg said.

Glover said regulators need to be willing and able to help colleagues in other countries with things such as inspection plans and reports. He noted that in July, Canadian officials inspected a Canadian facility operated by the drugmaker Apotex. A month later, inspectors from another "major" country inspected the same plant in the same way. After the panel discussion, he suggested creating a universal form for reporting adverse medical events that would mesh with a secure database, accessible to regulators around the globe, to enhance efficiency and catch more problems.

Hamburg said "almost all" processed food and drugs regulated by the FDA come to the United States, in part or whole, from 300,000 facilities in 150 countries through 100-plus ports of entry.

Rasi lamented the declining public trust in the pharmaceutical industry and in regulators, while more products of dubious nature are available on the market, often via the Internet.

"A growing number of people get access to unregulated substances," Rasi said. "They trust more the Internet, their neighbor, whatever source of media, when there is no regulation and no vigilance."

Contact David Sell at 215-854-4506 or dsell@phillynews.com or Twitter @PhillyPharma. Read his PhillyPharma blog on philly.com.

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