By Julian Pecquet - 05/25/11 02:34 PM EDT
Sanofi said in a statement to The Wall Street Journal, which uncovered the payments last year, that the citizen petitions brought "legitimate and important patient safety facts and considerations to the attention of FDA."
In a letter to FDA Commissioner Margaret Hamburg, Baucus and Grassley suggest the agency require that petitioners disclose their financial relationships with entities affected by FDA's decisions. The letter also requests that Hamburg explain "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."