Finance Senators urge FDA to respond to its citizen petition process

According to an article written by Julian Pecquet on May 25, 2011, 2 US Senators are urging the Food and Drug Administration to increase transparency in its citizen petition process, in the wake of alleged abuses by the drugmaker Sanofi.

The 2 finance Senators are Senate Finance Chairman Max Baucus (D-Mont.) and Sen. Chuck Grassley (R-Iowa). According to the report, these Senators sent a letter to the FDA detailing the financial relationship between the pharmaceutical company Sanofi-Aventis and physicians’ groups that lobbied the agency against approving generic drugs that would compete with Sanofi products.

The FDA is the Federal agency responsible for regulating foods, drugs, cosmetics, radiation-emitting electronic products, and medical devices–commodities that affect the daily lives of all Americans. The FDA provides the public with various opportunities to influence the way it regulates these products.One way is through the citizen petition process.

The citizen petition process allows individuals and health experts to raise concerns about the safety of medicines regulated by the FDA. But a new congressional investigation alleges that Sanofi paid more than $5 million to two medical groups and a researcher who unsuccessfully used the process to try to delay or prevent approval of generic versions of the blockbuster blood-clot treatment Lovenox.

In a report including documents acquired from Sanofi, Senate staff allege that the drugmaker “planned a coordinated strategy to delay generic alternatives to its blockbuster blood-thinner drug Lovenox” by encouraging the Society of Hospital Medicine (SHM), the North American Thrombosis Forum (NATF), and Dr Victor Tapson (Duke University, Durham, NC) to support Sanofi’s petition to delay FDA approval of the drugs used for prevention and treatment of acute venous thromboembolism. The SHM, NATF and Tapson all had financial relationships with the company, which made almost $3 billion from Lovenox in 2009.

In a statement from Senator Baucus, he said “Generic drugs help keep health care costs down and we absolutely cannot let powerful drug companies keep those life-saving drugs out of reach.”

“This report uncovers evidence that paying off doctors to lobby the FDA against generics was a drug company strategy — and that’s wholly unacceptable. The FDA needs to work closely with doctors, so we must ensure that doctors’ sole motivation is the well-being of their patients.”

Sanofi said in a statement to The Wall Street Journal, which uncovered the payments in June of last year, that the citizen petitions brought “legitimate and important patient safety facts and considerations to the attention of FDA.”

In the letter to FDA commissioner Margaret Hamburg, the Senators state, “When there are questions or concerns about the safety of a drug, they ought to be raised and resolved in a timely and thorough manner. The citizen petition process is one way that individuals and entities can express their concerns and seek appropriate government action. However, when misused or abused, the process can lead to delays in patient access to potentially affordable, safe, and effective generic alternatives.”

The letter also requests that Hamburg explains “what steps FDA (has) taken to ensure the integrity and transparency of the citizen petition process.”

“If the FDA isn’t asking for disclosure of financial relationships, it’s operating from an uninformed standpoint,” Grassley said. “The FDA has a responsibility to conduct due diligence in this area in order to make sure its reviews have credibility. Disclosure here and elsewhere with drug company payments helps to establish accountability when gathering input from experts.”

The Senators requested that the FDA answer their questions and address this matter by June 20, 2011.


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