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Bennet Looks to Beef Up FDA with New Bill

August 4, 2010

DENVER - A bill introduced in the Senate on Tuesday by Sen. Michael Bennet (D-Colo.) could strengthen the Food and Drug Administration's (FDA) powers to recall potentially unsafe drugs. Bennet says the additional authority is essential to help the FDA ensure the quality of drugs, now that their active ingredients are more likely to be manufactured overseas in places like India or China - countries with weaker regulatory standards.

"The FDA has the authority to order a medical device recall, but cannot currently order a drug recall."

The Drug Safety and Accountability Act was introduced on the heels of some high-profile voluntary recalls this year, including one involving Children's Tylenol.

A new poll conducted by the Pew Prescription Project finds overwhelming support for legislation that includes new safety measures for consumer drugs. Allan Coukell is a pharmacist and director of the Pew project.

"In the current environment, I don't think it's an automatic given that Americans across the political spectrum would support increased authority for a federal agency, and so I think it's striking that we see that finding."

In addition to giving the agency drug recall authority, Bennet says the bill also contains other measures to boost the agency's oversight abilities.

"The ability to subpoena documents and witnesses, the ability to assess civil penalties and better systems to receive information from other regulatory authorities, as well as from whistleblowers."

In 2009, there were a record 1,742 drug recalls — a 400 percent increase from the prior year — and up to 80 percent of the active ingredients in U.S. medications are now made overseas, says Coukell.

A statement from the Pharmaceutical Research and Manufacturers of America, a leading industry group, claims the U.S. regulatory system for drugs is already the toughest and safest in the world, adding that they look forward to reviewing the new legislation.

Information about the Pew poll is at http://tiny.cc/oz60x or www.prescriptionproject.org.

Eric Mack, Public News Service - CO