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Bill would increase FDA recall powers

New legislation has been introduced that would allow the US FDA to force companies to recall drugs which have been found to be unsafe

New legislation has been introduced in the Senate that would give the US Food and Drug Administration (FDA) the authority to force companies to recall drugs in cases in which the products have been found to be contaminated or unsafe.

The proposed legislation, known as the Drug Safety and Accountability Act of 2010, would also establish quality standards for the FDA, drug companies and the contractors to whom pharma firms often outsource manufacturing processes, and it would improve the federal government's system of tracking for drug manufacturing sites.

The FDA itself has recently said that it would seek expanded powers to enforce recalls and other drug safety measures in the wake of a number of high-profile drug-safety crises over the past several years.

The new legislation was introduced by Senator Michael Bennet, the Democrat from Colorado. It has won the support of The Pew Prescription Project, the AARP, the American College of Physicians, the Consumers Union, the Society of Chemical Manufactures and Affiliates, and Community Catalyst.

The increased US oversight is particularly important now that many outside manufacturing contractors are based overseas in places like India and China, according to a letter to Congress jointly signed by the organisations.

In conjunction with the introduction of the legislation, the Pew Prescription Project released a poll showing that nearly nine in ten Americans favour legislation mandating stricter safety measures for the drug supply. The poll also found that 70 per cent of respondents have little or no confidence that drugs made in China are safe for Americans and that 54 per cent had safety concerns about drugs manufactured in India.

Pharmaceutical Research and Manufacturers of America (PhRMA) said that it was still reviewing the bill, but reiterated its conviction that the US regulatory system for prescription drugs is already "the toughest and safest in the world."  

"PhRMA and its member companies have been working with Congressional leaders over the last several years on ideas for making further improvements to the safety of our drug supply," the trade group said. "We look forward to reviewing US Senator Michael Bennet's bill closely as part of that continuing effort."

4th August 2010

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