Alerts and Updates

Pharmaceutical Manufacturers Be Aware

February 29, 2008

Baxter International has recalled thousands of vials of its blood thinner, Heparin, after it was linked to four deaths and hundreds of allergic reactions. On Monday, February 18, 2008, the Food and Drug Administration (FDA) stated that it had failed to inspect the Chinese plant in which the active pharmaceutical ingredient (API) in the recalled Heparin was manufactured because the FDA confused it with a different company with a similar name. In response, on Thursday, February 21, 2008, U.S. Representatives John Dingell (D-MI) and Bart Stupak (D-MI) stated that they are considering proposing legislation that would make illegal the marketing of a drug in the United States where the API is from a manufacturing plant that has not been inspected by the FDA.

Currently, there is no legal requirement that a plant be inspected by the FDA prior to importation of an API into the United States. There are, of course, registration, listing and cGMP (current good manufacturing practices) requirements, but no inspection requirements. It is far from clear whether the FDA has the resources to conduct such mandated inspections; nonetheless, if Rep. Stupak actually proposes legislation that then is passed by Congress and signed into law, this would be a sea change in the law governing the importation of APIs into the United States.

For Further Information

If you have any questions about this Alert or would like more information, please contact Frederick R. Ball, any of the lawyers in the Pharmaceutical & Biotechnology industry group or the attorney in the firm with whom you are regularly in contact.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.