New FDA Rules Increase Restrictions on Outside Consulting
FDA has implemented new rules that require employees to obtain approval before they can begin paid or unpaid outside activities with pharmaceutical and biotechnology companies, the AP/Las Vegas Sun reports. According to acting FDA Commissioner Lester Crawford, "FDA must be clean and pure. We have to watch ourselves" (Henderson, AP/Las Vegas Sun, 8/10). FDA implemented the new rules after Crawford in May launched an internal investigation to determine the extent of pharmaceutical and biotech company payments to agency employees. An earlier NIH Blue Ribbon Committee on Conflict of Interest Policies investigation into allegations of conflicts of interest among NIH employees who received consulting payments and stock options from pharmaceutical companies had found that Emanuel Petricoin, a senior microbiologist at FDA, received consulting payments from California-based Biospect, which in May became Predicant Biosciences.
In late 2002, FDA allowed Petricoin to enter into a paid consulting agreement with Biospect, although in April 2002, the agency had assigned him to help Maryland-based Correlogic Systems develop an ovarian cancer test. Biospect and Correlogic were potential competitors at the time, according to documents and individuals familiar with the situation (California Healthline, 5/18).
Jeff Weber, associate commissioner for management at FDA, said that the internal investigation examined more than 1,800 outside activity forms submitted by employees over the previous five years and found no new ethical violations. However, FDA "further tightened its rules for Crawford's peace of mind," the AP/Sun reports. Under the new rules, implemented in June, FDA reviews outside activities forms submitted by employees every year, rather than every five years, and only center directors can approve those forms. In addition, more FDA employees have to declare their financial holdings. FDA by October will enter such information into a computer database that will allow agency officials to determine where employees might hold second jobs (AP/Las Vegas Sun, 8/10).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.