Dingell introduces bill that would increase regulation of imported drugs

By Correy Stephenson

The Daily Record Newswire

The Food and Drug Administration would have greater power to regulate drugs imported into the United States after being manufactured elsewhere under legislation recently introduced in Congress.

The Drug Safety Enhancement Act, H.R. 1483, was introduced by Rep. John D. Dingell, D-Mich.

It is intended to "give [the] FDA much-needed authority and resources to address the safety gaps in our drug supply system," Rep. Dingell said in a statement.

Under the legislation - which includes both civil and criminal penalties - manufacturers would be required to list the country of origin for both drugs and drug components, as well as notify the FDA of counterfeits or any safety concerns.

Manufacturers would also be required to implement stronger quality and safety standards and greater supply chain management.

The bill would increase FDA foreign manufacturing inspections to a level equivalent with domestic facilities and would establish a registry of all drug facilities, both foreign and domestic, serving American consumers.

The FDA would also receive greater powers of detention, destruction and mandatory recall for drugs, as well as subpoena power and greater extraterritorial jurisdiction.

Facilities that delay or deny FDA inspections would have their drugs barred from entering the country.

"For too long, Americans have suffered from the challenges FDA and the industry face in ensuring the safety of the U.S. drug supply.

"We must address the deficiencies uncovered by recent recalls," Rep. Dingell said, in reference to the drug heparin.

"The Drug Safety Enhancement Act is a strong and effective response to the troubles we face with an increasingly global and complex drug supply."

Published: Thu, Apr 28, 2011


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