April 3, 2006

FDA officials have accepted more than $1.3 million in sponsored travel since 1999 from groups closely associated with pharmaceutical and medical device firms due to a loophole in agency policy, according to a recent report issued by the Center for Public Integrity (CPI).

These trips could potentially influence agency decisionmaking, CPI intimates in its report, "FDA Staff Travels on Drug Industry Dollars." The group points out that 17 of the agency's 29 Drug Safety Oversight Board members have combined taken more than 160 privately sponsored trips, at a total cost of $220,000.

The study analyzed all available FDA reports of privately sponsored trips costing more than $250 between October 1999 and September 2005. FDA officials who accepted the trips include many division and department directors, CPI noted.

Nonprofit groups and universities paid for roughly one-third of the more than 3,600 total trips agency officials took over this period, the report said. The Drug Information Association (DIA) alone sponsored more than 600 of these trips, CPI said. Other groups picking up the travel tab included the Regulatory Affairs Professionals Association (RAPS), American Association of Pharmaceutical Scientists, Parenteral Drug Association, World Health Organization, International Society for Pharmaceutical Engineering and Orange Country Regulatory Affairs Discussion Group.

Although FDA policy bars employees from taking trips paid for by companies and trade groups, associations such as the DIA do not identify themselves as industry trade associations, CPI noted. Instead, these groups promote themselves as scientific associations, thereby avoiding the restriction, according to the center. Yet all of these groups have had strong ties to the pharmaceutical, biologic and medical device industries, CPI said.

For example, 13 members of DIA's 16-member board of directors work or have worked for these industries or their affiliated consulting groups, CPI said.

The FDA countered that it has stringent policies, procedures and employee guidances in place to ensure compliance with federal travel regulations, as well as staff to closely oversee and monitor travel-related activities.

"We take this responsibility seriously -- both to abide by the regulations and to preserve the public trust and even the appearance of impropriety," an FDA spokeswoman told FDAnews. "As such, there should be no question in anyone's mind that FDA oversight and compliance is proper and adequate and our employees' conduct is beyond reproach."