Over the years it has become quite apparent that the powerful drug industry has enjoyed tremendous control over the Food and Drug Administration. We now learn that, through an apparent loophole in agency rules, the FDA has allowed its employees to receive more than $1.3 million in sponsored travel since 1999 from groups closely tied to pharmaceutical and medical device companies. Interestingly, FDA policy clearly bars employees from taking trips paid for by the drug, medical device and other companies the agency regulates. This ban also applies to their trade groups. But the Center for Public Integrity has identified nonprofit associations that draw their members, their boards and even some of their funding from medical and pharmaceutical-related companies paying for the travel of hundreds of FDA employees.

The sponsor of the most trips was the Drug Information Association (DIA), which paid for more than 600 trips taken by FDA employees. The nonprofit group, which interestingly is made up of pharmaceutical and medical device manufacturers’ employees, academics and government regulators, has 13 members on its board of directors who presently work for the industry or its consulting groups. Many observers believe that the FDA, which is the sole regulatory agency responsible for controlling drug companies, is much too close to the industry it oversees to impartially and effectively police the roughly 10,000 drugs on the market. I totally agree with that assessment.

At Congress’ request, the Inspector General of the Department of Health and Human Services has investigated ties between the industry and the agency that oversees it. Many of the top sponsors have membership or financial ties to medical and pharmaceutical-related companies. According to a report, nonprofit groups and universities with such ties paid for roughly a third of the more than 3,600 trips taken by agency officials, suggesting that the industry is indirectly subsidizing the travel taken by FDA employees.

It certainly appears that the sponsored travel should be curtailed. It involves employees with the FDA who simply must not be allowed to get indebted to the very industry they are called on to regulate. The Center for Public Integrity analyzed all of the FDA’s available reports of privately sponsored trips taken by agency officials between October 1999 and September 2005 that cost more than $250. The ranks of travelers included many key employees such as division and department directors. In fact, the travelers included two members of the FDA’s new Drug Safety Oversight Board. That safety board was established last year to independently monitor approved drugs. According to the Washington Post, seventeen of the board’s 29 members have taken one or more of a combined 160 privately sponsored trips, at a total cost of more than $220,000. Remember, this is the board that was established because of the recall of Vioxx and other potentially dangerous medications.

The Post reported that more than a quarter of all of the trips reported were sponsored by five groups with ties to the pharmaceutical, biologic and medical device industries: the Drug Information Association, the American Association of Pharmaceutical Scientists, the Parenteral Drug Association, the International Society for Pharmaceutical Engineering, and the Regulatory Affairs Professionals Society. They were responsible for close to 1,000 excursions, spending more than $1.3 million to fly and host agency employees. Consumer and government watchdogs worry that trips sponsored by those with financial ties to regulated companies provide opportunities for pharmaceutical, medical device and other related industries to set the agenda for the FDA. Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group, which monitors the FDA and the health industry, stated:

There is no countervailing perspective. They mostly become schmooze-fests for people from industry.

Bill Vaughan, senior health policy analyst with Consumers Union, who also believes there is a major problem, says: “It contributes to the revolving door.” There are numerous examples of where FDA officials and staff members have gone on to industry jobs. Currently, several former FDA officials now work for the very industry they policed while working for the agency. Some are involved with groups that formerly funded their travel. The Center identified 20 former FDA officials who took trips sponsored by one of the five associations that went on to work for medical and pharmaceutical-related companies. This sort of thing must be stopped for obvious reasons. Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, who has been critical of the FDA’s reliance on travel sponsorship by DIA and other nonprofits, said:

It sounds like they’re violating the spirit of the law, if not the letter of the law.

The rules were actually toughened in 1988. This came about after several FDA employees were caught taking payoffs, expensive trips and pricey meals from generic drug companies. As a result, outside groups were barred from sponsoring travel. But the tide turned in 1992, when Congress passed the Prescription Drug User Fee Act, which actually required drug companies to fund the drug approval process. DIA was again permitted to sponsor travel around that time. Restrictions on travel sponsorship by several other groups were also relaxed after passage of the PDUFA legislation. While the FDA and the drug companies may not be breaking the law, this surely does look like massive conflicts of interest. At the very least – this sort of thing doesn’t pass the smell test where I come from!

Source: Washington Post

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