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Consumer and manufacturing groups back bill to protect US drug supply
Date:8/3/2010

The Pew Prescription Project, joined by major consumer, physician and chemical manufacturer groups, today announced support for a new bill that would give the U.S. Food and Drug Administration (FDA) much-needed authorities to better protect pharmaceutical supply chains. The organizations made the announcement in a joint letter to Congress and during an audio news conference with Senator Michael Bennet (D-CO), who will introduce this drug safety legislation.

Consumers face a surge in drug recalls, with a 400 percent increase in 2009 compared with the previous year. This year, the trend has continued with the high-profile voluntary recall of over 130 million bottles of over-the-counter children's drugs.

To boost consumer protections against adulterated drugs, the proposed legislation would establish quality standards for the FDA, drug companies and their contractors, who are increasingly based overseas, where safeguards may be lower than in the U.S. The legislation also would improve the federal government's tracking systems of manufacturing sites. The FDA has recently signaled it will strengthen inspection and quality requirements for drug makers who outsource to suppliers and suggested the agency should have the authority, currently lacking, to require a company to recall drugs that have been found to be contaminated or unsafe.

In the wake of more than 100 U.S. deaths associated with contaminated heparin from China, Americans' trust in imported drugs has been badly shaken. A survey commissioned this spring by the Pew Prescription Project found an overwhelming majority of Americans94 percentsupport giving the FDA authority to recall drugs when they are found unsafe or contaminated. This poll of likely voters found that 70 percent of respondents have little or no confidence that drugs manufactured in China are free from contamination and safe for Americans and 54 percent expressed the same concern about drugs manufactured in India. The
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Contact: Linda Paris
lparis@pewtrusts.org
202-540-6354
Pew Health Group
Source:Eurekalert

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