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Hearing of the Subcommittee on Oversight & Investigations of the House Committee on Energy and Commerce - FDA Foreign Drug Inspection Program


Location: Washington, DC


REP. MARSHA BLACKBURN (R-TN): Thank you, Mr. Chairman. I thank you for calling the hearing to examine this foreign drug inspection program.

The inadequacies of our food and drug import system have been widely reported during the past year and you've had The New York Times article referenced several times already today.

There is a serious problem; we all recognize that. Given that the U.S. imports 80 percent of the active drug ingredients, it is critical that the federal government improve its drug monitoring safety system to ensure that the U.S. drug supply remains the safest in the world.

The volume of FDA-regulated pharmaceutical imports doubles every five years and will continue to increase. How much weight can American consumers give to the label "FDA-regulated" when the FDA cannot perform timely safety inspections?

When the agency fails to enforce action against foreign manufacturers and lacks the tools to monitor foreign drug manufacturers, how can Americans feel safe?

If American drug manufacturers are required to follow the letter of the law regarding FDA drug safety inspections, Congress should expect nothing less from foreign manufacturers. Foreign manufacturers must play by the same rules that our domestic manufacturers follow.

If consumer safety is priority number one, and it should be, then we have a lot of work to do to ensure that this goal is going to be met.

It is worth noting, however, that many of the voices calling for an overhaul of the U.S. drug safety inspection system concurrently call for legislation that would import prescription drugs from other nations. Drug re-importation fails to ensure the high safety standards that Americans have come to expect. Americans clearly do not need a flood of unsafe prescription drugs finding their way into the medicine cabinets across this country, especially since there is no guarantee of quality or that imported medication is indeed safe for use. When someone gets that imported drug and it turns out to be unsafe, we have another public health threat on our hands.

This subcommittee has examined drug import safety in numerous hearings during the 110th Congress and the record shows that it is unrealistic for the FDA to inspect all imports coming into the United States. However, Americans demand greater accountability in the nation's drug supply through considerable and expedient improvement of the FDA's current drug safety review system.

I look forward to the testimony today from our witnesses and I yield back the balance of my time.


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