Rx for a global safety net

In practical everyday terms, does it matter to the community or health system pharmacist that the Food and Drug Administration is forging ties with other agencies worldwide and becoming more international in its outlook and focus? You bet.

The FDA released a report on April 23 that detailed a slew of initiatives and strategies the agency is taking "to transform from a domestic to a global public health agency." The report described steps the FDA is taking "to ensure that imported food, drugs, medical devices and other regulated products meet the same rigorous standards for safety and quality as those manufactured domestically."

Among those steps: Improving information sharing among the regulatory oversight agencies in different nations about potential threats to public health from defective products or substandard manufacturing techniques, so that faster and more effective countermeasures can be mounted. (For a copy of the report, click here.)

This isn't some wonky exercise by overreaching federal bureaucrats. This is government at its best, doing what it's supposed to do: Protecting the public health. And it's vitally important to pharmacy.

"Today we recognize that to successfully protect the U.S. public health, we must think, act and engage globally," FDA commissioner Margaret Hamburg said. "Our interests must be broader than simply those within our own borders."

The numbers behind that assertion are striking. The U.S. now imports no less than 40% of finished dosage drugs – the ones you dispense to your patients – and more than 80% of the active pharmaceutical ingredients used to make our medicines. What's more, according to Hamburg, FDA-regulated products originate from more than 150 countries, 130,000 importers, and 300,000 foreign production centers large and small. And imports of pharmaceutical products are growing at nearly 13% a year.

Hamburg said drug safety is a global challenge that will require a global alliance and "new, unprecedented, even unexpected, ways to build a public health safety net for consumers around the world."

Is she right? And, if so, is the FDA doing enough, fast enough, to ensure that safety net here at home? Please let us know what you think.

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