Members of the Senate Finance Committee are asking the FDA to delineate the steps taken to keep the citizen petition process transparent after it found that Sanofi-Aventis may have hidden financial relationships with societies and individuals that may have helped the company lobby against approving generic drugs that offer competition to the drug maker’s enoxaparin (Lovenox).
The committee asked Sanofi to turn over records regarding enoxaparin, a drug developed for the prevention of deep vein thrombosis, after an article in the Wall Street Journal ( WSJ) published June 24, 2010 , divulged that two physicians’ groups and a Duke professor may have lobbied to keep generic drugs similar to enoxaparin off the market.
Almost one year after the WSJ article, the committee members, in a May 24 letter to the FDA, sought to elucidate the details of a financial relationship between Sanofi-Aventis and physicians’ groups.
Sens. Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) sent a letter to the FDA, stating that internal Sanofi documents imply that medical societies—the North American Thrombosis Forum (NATF) and the Society of Hospital Medicine (SHM)—along with a Duke University professor, Victor Tapson, MD, petitioned the FDA to delay the approval of generic alternatives to Sanofi-Aventis’ blockbuster drug to ward off market competition.
Back in June 2010, the WSJ reported the two societies and Tapson submitted letters to the FDA in support of a citizen petition filed by Sanofi-Aventis in 2003. The petition attempted to move the agency to delay approval for generic versions of Lovenox; however, the WSJ said the medical groups and the professor neglected to make their financial relationships with Sanofi-Aventis public.
After a review of Sanofi-Aventis' internal documents, Baucus and Grassley raised an important issue: Why aren't these types of concerns about drug safety or financial ties resolved or disclosed?
“The citizen petition process is one way that individuals and entities can express their concerns and seek appropriate government action,” Baucus and Grassley noted. “However, when misused or abused, the process can lead to delays in patient access to potentially affordable, safe, and effective generic alternatives.”
The WSJ article insinuated that both NATF and SHM, along with Tapson, worked in conjunction with Sanofi-Aventis to halt sales of cheaper generic alternatives, that have been shown to significantly reduce costs for patients. In fact, the Congressional Budget Office reported that generic drugs condensed costs by almost $33 billion in the Medicare Part D program in 2010 alone.
The FDA is assessing ways to reform the generic drug approval process. In light of this specific situation, Baucus and Grassley asked the agency's Commissioner Margaret A. Hamburg to respond to the following questions:
- Has FDA considered requiring organizations that submit letters to the FDA under the citizen petition process to disclose their financial relationships with entities affected by FDA’s decision to grant or dismiss a citizen petition? If not, please explain why not; and
- What steps has FDA 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. 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,” Grassley said in a statement.
Back in August 2010, the U.S. District Court for the District of Columbia rejected Sanofi-Aventis' plea to request an injunction relief against the FDA's approval of Sandoz Pharmaceuticals' generic version of Lovenox. During the injunction request, Sanofi-Aventis argued that Sandoz did not adequately provide additional data outlining the drug's safety and effectiveness.