WASHINGTON - In light of recent questions about possible conflicts of interest involving scientists at the National Institutes of Health, FDA's acting commissioner Lester Crawford has directed a comprehensive review of all current outside consulting requests from FDA employees.
Once the review is completed, the FDA will issue a final policy on the review and approval of such agreements, Crawford said.
The issue surfaced back in December when the Los Angeles Times wrote an article detailing the decade-long practice of high-level NIH scientists receiving hefty fees for consulting with pharmaceutical and biotechnology companies. The NIH controls millions of dollars in research grants and some officials here believe the organization's integrity could be compromised by financial relationships between scientists and the industry.
In response, Congressional committees, including the House Energy and Commerce Subcommittee on Oversight and Investigations, have started looking into the matter.
Under NIH policy there is no limit on the amount of compensation or the number of hours a scientist can be paid for outside consulting jobs. Employees are not required to disclose what they are paid. Since other government departments operate under similar rules, the subcommittee members said they would investigate those departments, as well. (See BioWorld Today, May 13, 2004.)
Meanwhile, at the FDA current policy allows employees to contract their services with the permission of mid-level managers. Crawford believes that authority should be delegated to a higher level, therefore he's implemented an interim policy requiring center directors to review and approve all outside activity requests.
Since 1970, Crawford said, the FDA has had an aggressive disclosure and review process that is designed to ensure that its employees do not have any conflict of interest involving companies and entities that the FDA "significantly regulates." The FDA has placed reasonable restrictions on the financial and employment ties between its employees and the entities it regulates, he said.
The NIH, however, came under fire because some of its employees were receiving consulting fees that included cash as well as stock options.
For example, since 1995 Ronald Germain, a world-renowned scientist who is deputy chief of the National Institute of Allergy and Infectious Diseases, has earned $430,535, plus stock options, for services outside his NIH office.
NIH Director Elias Zerhouni, who believes interaction between the industry, academia and the government is important to the advancement of science, has proposed a set of guidelines for dealing with consulting work. At the top of the list, Zerhouni wants to prohibit NIH scientists from accepting stock or other forms of equity ownership in the companies they consult with. Senior-level NIH scientists, management and extramural employees who are responsible for program funding decisions and recommendations would be prohibited from receiving consulting fees. Employees allowed to consult would be limited to a fee equal to 50 percent of the employee's annual salary, with no one source accounting for more than 25 percent of an annual salary.