Washington, D.C. – Today, Congressman John D. Dingell (D-MI15) made the following opening statement at the House Energy and Commerce Subcommittee on Oversight and Investigation hearing on “Import Safety: Status of FDA’s Screening Efforts at the Border”:
“Mr. Chairman, I thank you for holding today’s hearing. For too long, Americans have suffered from unsafe pharmaceuticals coming into this country from foreign manufacturers and counterfeit drug operations. The Heparin crisis was a wakeup call that the FDA needs greater authority to stop unsafe pharmaceuticals and pharmaceutical ingredients from crossing our borders. Just yesterday I introduced with my colleagues Ranking Members Waxman, Pallone and DeGette, H.R. 1483, the Drug Safety Enhancement Act. This legislation would give FDA much-needed authorities and resources to address the safety gaps in our drug supply system.
“This legislation would:
o Require manufacturers to implement improved quality and safety standards, including stronger supply chain management;
o Require manufacturers to notify FDA of counterfeits or safety concerns and to list drugs and drug components country of origin;
o Strengthen importers and customs brokers oversight;
o Arm FDA with administrative detention, destruction, and mandatory recall authorities, subpoena power, and clear extraterritorial jurisdiction;
o Strengthen criminal and civil penalties for crime deterrence;
o Increase FDA foreign manufacturing inspections to be on par with domestic facilities; and,
o Create new funding mechanisms for FDA inspectional activities, so globalization doesn’t burden US taxpayers.
“This last point is an important one. At the same time this Committee and Congress are asking the FDA to do more, the new Majority is cutting their funding. The FDA serves as the watchdog for what food, drugs, devices and cosmetics are coming across our borders and they need a steady, reliable stream of funding to carry out their duties. Further, we need to address gaps in authorities that are leaving consumers vulnerable to shoddy practices overseas. I sincerely hope my colleagues on both sides of the aisle will work with me to provide FDA with the authority it needs to improve the safety of imports coming across our border.”
To view a video copy of his opening statement, click here. To view a video copy of his questioning at today’s hearing, click here.
Congressman Dingell has long been an advocate for the rights and safety of consumers and continues vigorous oversight in the 112th Congress to improve FDA authorities and import safety to best protect consumers.
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