FDA

Senators urge more disclosure for FDA lobbyists

Reuters News
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Posted: May 25, 2011 4:50 PM
Senators urge more disclosure for FDA lobbyists

By Anna Yukhananov

WASHINGTON (Reuters) - Two U.S. lawmakers are urging the Food and Drug Administration to require lobbying groups to disclose their financial ties to major pharmaceutical companies.

Senate Finance Committee Chairman Max Baucus and panel member Charles Grassley sent a letter to the FDA on Wednesday, asking the agency to improve the transparency of its petition processes.

The letter follows a congressional report that showed a financial relationship between French pharmaceutical company Sanofi and physicians' groups that petitioned the FDA against approving certain generic drugs that would compete with Sanofi products.

"This report uncovers evidence that paying off doctors to lobby the FDA against generics was a drug company strategy -- and that's wholly unacceptable," Baucus, a Democrat from Montana, said in a statement.

The report showed Sanofi gave two medical groups, the Society of Hospital Medicine and the North American Thrombosis Forum, $2 million each and also gave $200,000 to Victor Tapson, a medical professor at Duke University.

Tapson and both medical groups petitioned the FDA as part of its citizen petition process against approving generic drugs that would compete with Sanofi's blood-thinner Lovenox.

According to the senators' letter, Sanofi received $2.9 billion from Lovenox sales in 2009.

Sanofi said it often works with medical societies and physicians on issues such as patient safety.

"Where there is an appropriate forum for public discourse, we may encourage experts in the field to express their own opinions," Sanofi said in a statement to Reuters.

"The Citizen's Petition on Lovenox and the comments of some of the outside experts brought legitimate and important patient safety facts and considerations to the attention of FDA," the company said.

The FDA could not be immediately reached for comment.

A separate "Sunshine Act," was introduced in 2008 by Grassley, a Republican from Iowa, and Democratic Senator Herb Kohl of Wisconsin. It passed as part of the 2010 health care law and requires by March 2013 that all companies disclose via the Internet any payments made to doctors.

(Reporting by Anna Yukhananov; Editing by Tim Dobbyn)