Background: Clifford Bundy Stearns Sr. (born April 16, 1941) was the U.S. Representative for Florida's 6th congressional district from 1989 to 2013. He is a member of the Republican Party. On August 14, 2012, Stearns lost to veterinarian Ted Yoho in a four-way Republican primary by about 1 percent of the vote.
Context: Stearns led the congressional effort involving the meningitis outbreak. As of November 14, 2012, the Centers for Disease Control and Prevention (CDC) has confirmed 32 deaths and that 438 people have been sickened across 19 states. An investigation determined that the New England Compounding Center(NECC) was the source of the contaminated product. As Chairman of the House Energy and Commerce Committee's Subcommittee on Oversight and Investigations, Stearns held a hearing on this outbreak.  During the hearing, Stearns stated the outbreak was preventable had the U.S. Food and Drug Administration (FDA) acted. The FDA knew of severe quality control violations at NEC as early as 2002, and in 2006 the FDA threatened NECC if it did not comply with regulations. During the hearing, FDA Commissioner Dr. Margaret Hamburg testified that the FDA lacked the authority to close down NECC.  Stearns noted that the FDA had authority to close NECC, but simply failed to protect the American people. Dr. Scott Gottlieb, deputy commissioner of the FDA from 2005-07 and Mr. SheldonBradshaw, FDA's chief counsel during that same period, disagreed strongly with Hamburg. In a Wall Street Journal op-ed on November 13, 2012, they stated unequivocally that FDA did have enough authority and could have acted but chose not to because of FDA's desire to regulate "the full scope of the practice of pharmacy." They further stated that NECC's illegal actions, which FDA was aware of, that "put the NECC firmly in violation of FDA rules-if the agency had chosen to enforce existing provisions."
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During the hearing, Stearns stated the outbreak was preventable had the U.S. Food and Drug Administration (FDA) acted.