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FDA to Increase Industry Executive Prosecutions
Plans have been announced by the FDA to increase prosecutions of pharmaceutical and food industry executives as part of an effort to refocus its criminal division, which has been under attack in Congress and is criticized in a new government report.
The FDA says an internal committee has recommended that the FDA and its Office of Criminal Investigations "increase the appropriate use of misdemeanor prosecutions, which allows responsible corporate officials to be held accountable and is a valuable enforcement tool." In a letter that was sent to Senator Chuck Grassley of Iowa.
The FDA has said they have the authority to prosecute corporate executives for criminal actions within their companies under a provision called "strict liability," where the government doesn't have to show intent to defraud in order to get a conviction. The provision is an important tool that hasn't been used much in recent years. The agency further stated they intend to apply the provision thoughtfully and doesn't want to be viewed as overly aggressive.
Congresses' watchdog arm, says the Office of Criminal Investigations has operated autonomously for years with little or no accountability to top FDA officials. No explanation of how funds are spent is required of the criminal office. The office's budget rose 73% between 1999 and 2008 to $41 million, and the number of employees increased by about 40%. The GAO also said the FDA's criminal unit has fallen short compared with other agencies in developing performance standards. The FDA officials largely agreed with the assessment and in the letter said the agency is "developing meaningful performance measures" for the criminal office as part of an initiative begun in August. The FDA said it wants the criminal office to share information with FDA leaders regularly, and to do a better job picking cases.
http://online.wsj.com/article/SB10001424052748703862704575099942109582112.html?mod=dist_smartbrief
Penicillin Allergy Patients Okay with Cephalosporins if Tested, Study Finds
Patients with a history of penicillin allergy can safely take cephalosporins, U.S. researchers say. "Almost all patients undergoing major surgery receive antibiotics to reduce the risk of infections. Many patients with a history of penicillin allergy don't get the cephalosporin because of a concern of possible drug reaction. They might get a second-choice antibiotic that is not quite as effective," study author Dr. James T. Li, of the Mayo Clinic in Rochester, Minnesota, said in a news release from the American Academy of Allergy, Asthma & Immunology.
Dr. Li and colleagues conducted penicillin allergy skin tests on 178 patients who reported a history of severe allergic (anaphylactic) reaction to penicillin. The tests yielded 10 unclear results, 12 positive results, and 156 negative results. Later, 80 of the 156 patients with negative skin tests to penicillin received a cephalosporin when they had surgery. Just one patient experienced a possible mild adverse reaction to the cephalosporin.
Dr. Li says that "Even patients with a history of a serious reaction to penicillin can receive cephalosporins safely if the allergy tests are negative. The main message here is that patients with a history of penicillin allergy who need surgery can benefit from consultation with an allergist. They can get the best antibiotic with the lowest risk of drug reaction."
http://healthday.com/Article.asp?AID=636322
Merck to Pay $7.2 Billion for Millipore
Merck of Germany is purchasing Millipore, an American provider of purifiers and filters for biotechnology laboratories, for about $7.2 billion, including debt. Merck will become the latest healthcare company to strike a deal during a period of industrywide consolidation. The takeover gives Merck a big presence in products for the biotechnology industry.
http://www.nytimes.com/2010/03/01/business/01merck.html?adxnnl=1&adxnnlx=1267808746-JQS6WkKu4CkcLTee3FFPBA
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