Act aims to fortify FDA rule of non-U.S. drugs

Newly introduced legislation attempts to ensure both safety and quality in drugs manufactured outside the U.S. On Tuesday, Sen. Michael Bennet introduced the Drug Safety and Accountability Act of 2010 to increase the FDA's power to ensure U.S. drugs are safe and effective regardless of where they are made.

The Senate legislation follows by about two weeks a House filing by Rep. Ed Towns to arm the FDA with its own recall authority, which would allow the regulator to act more quickly than sometimes is the case with the current norm of voluntary manufacturer recalls. The idea is for the FDA to be able to sidestep the task of persuading companies to recall suspect products.

The Senate bill filed by Bennet also would provide the FDA with additional recall power, in addition to other enforcement options. Among them: authority to assess civil penalties and to subpoena documents and witnesses.

In contrast to the House bill, the Senate's has a supply chain focus. It attempts to strengthen manufacturing quality standards industry-wide, reaching beyond U.S. borders to such countries as China and India, home of a growing population of contractors governed by less stringent regulatory standards than the U.S.'s.

The bill would require that drugmakers institute quality management plans to ensure drug safety and strengthen supplier oversight. A related requirement involves documentation of all supply chain members.

The bill appears to be a reaction to contaminated heparin from China that resulted in more than 100 deaths. Questions remain about that incident, which occurred in 2007 and 2008. Congress has recently asked FDA Commissioner Margaret Hamburg to investigate further and take action.

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