On February 3, 2005, the NIH released new regulations governing NIH employee’s collaborative arrangements with biotechnology and pharmaceutical companies.  The new regulations concerning conflicts of interest ban senior NIH employees from accepting outside consulting relationships with pharmaceutical and biotechnology firms.  Mid-level scientists will have their outside activities restricted.  These regulations were posted in the February 3, 2005, Federal Register.   Currently we are in a 60-day comment period that ends April 4, 2005.  These regulations are final unless amended, and this period provides ASPET and other interested individuals and organizations with the opportunity to comment and provide testimony that would justify a change in these regulations. 

The website for the full Federal Register notice, a summary of the rule, and questions and answers regarding these regulations are provided by the NIH at http://www.nih.gov/about/ethics_COI.htm.

ASPET agrees that maintaining the integrity of the NIH enterprise is critical.  However the action of a small number of scientists have breached this public trust and the resulting guidelines potentially raise unanswered questions and could create significant unintended consequences, including:  

• the ability of NIH to recruit and retain leading scientists;
• determining how extensive the interaction between NIH scientists and professional societies may be permissible. 
• will scientists serving on leadership positions within professional societies, as editors of peer-reviewed journals, or other voluntary or elected position be permitted? 
• can an NIH employee who serves as editor of a peer reviewed journal accept reimbursement for administrative costs, including administrative support personnel, telephone, fax, etc?
• what level, if any, may an employee be compensated for or reimbursed for expenses or provided honoraria resulting from their activities to the professional society;
• what is the rationale to treat service to professional society journals treated in the same manner as ownership or consulting to biotechnology or pharmaceutical companies?
• how will these regulations impact the extramural community? 
• what is to prevent these regulations from being applied to all NIH funded extramural scientists?
• will members of NIH study sections be exempt from the conflict of interest regulations?
• what mechanisms are in place to determine what is permissible on a case-by-case basis?
• what are the implications for other federal agencies that award competitive grants and interact with industry?

On February 23, the Washington Post reported that 80% of the approximately 100 NIH researchers the agency said were under investigation for engaging in undisclosed financial arrangements with pharmaceutical and biotechnology companies have been cleared by NIH investigators.  According to the Washington Post, “The unexpected finding that as much as 80% of the seeming improprieties were actually the result of errors by government investigators has undermined the rationale behind NIH Director Elias A. Zerhouni’s recent decision to impose severe restrictions on the personal activities and finances of all the agency’s more than 5,000 employees..”  An editorial also appearing on February 23 in the Washington Post suggests that the new rules, “Particularly a broad prohibition on owning stock in drug companies and other firms potentially affected by NIH, go to far.  They threaten the ability of the institutes to attract and retain top scientists without providing significant safeguards against conflict of interest.”    

February 23, 2005