How Big Pharma Peddles Influence in FDA Panel Meetings

When the federal government wants to set medical policy and testing standards, it assembles a panel of experts to analyze the state of that particular medical art and make recommendations to the FDA. You would hope-and expect-that the process would be strictly analytical and scientific, uncontaminated by outside commercial interests.

In at least one recent case, you would be wrong.

As reported by the Washington Post, a panel that shaped the government’s policy for testing the safety and effectiveness of painkillers was subsidized by pharmaceutical companies that paid hundreds of thousands of dollars for, essentially, access. They wanted to influence the thinking of the FDA, according to emails secured through a public records request.

The emails show that the companies paid as much as $25,000 to attend a meeting of academics intended to provide advice to the FDA on how to analyze evidence from clinical trials.

The communications suggest that the regulators had become too cozy with the companies who profit in the $9 billion U.S. painkiller market. FDA officials who regulate these meds also served on the steering committee of the panel, which met in private, and co-wrote papers with employees of pharmaceutical companies.

We’ve written in several posts about the questionable control of painkillers (here and here), and The Post’s story is yet more evidence that the FDA has been less than conscientious in addressing the epidemic of addiction to prescription drugs such as Oxycontin and other opioids.

“Instead of protecting the public health, the FDA has been allowing the drug companies to pay for a seat at a small table where all the rules were written.” Craig Mayton, the attorney who made the public records request, told The Post.

It’s not as if the FDA was unaware of this conflict of interest. “Even as the meetings were taking place,” according to The Post, “the idea of FDA officials meeting with firms that had paid big money for an invitation raised eyebrows for some. In an e-mail to organizers, an official from the National Institutes of Health worried whether the arrangements made it look as if the private meetings were a ‘pay to play’ process.”

And although FDA officials did not benefit financially from participating in the meetings, two later worked as pharmaceutical consultants. The whole scenario portrays an agency that blurred the line between the regulators and the regulated.

FDA officials offered, in our estimation, a lame explanation, saying that strict rules of transparency and funding apply to the public-private partnerships that the agency engages in. But the group in this case was not initiated by the FDA, so it was a private partnership to which those rules did not apply.

The group was organized by two medical professors, one from the University of Rochester and one from the University of Washington, and the emails describe their efforts at financing and organizing the group’s meetings.

The professors got as much as $50,000 each for a meeting. The funds supported their academic research and expenses “or to cover a small percentage of faculty effort,” they said. In one email, they proposed receiving $5,000 each for a four-hour meeting near the FDA offices.

The meetings concerned the best methods for measuring the effectiveness of painkillers. One professor told The Post that their intent “was to help everybody develop better drug trials.” Both professors were responsive to The Post, but the Pharmaceutical Research and Manufacturers of America declined to comment.

The goal of the group was to publish “consensus” statements on scientific matters related to testing the drugs, and one of the professors said the scientific guidelines the group produced were of high quality.

The meetings included 30 or 40 people, including academics, FDA and National Institutes of Health (NIH) officials, and often as many as 14 representatives from pharmaceutical companies. Only the companies paid fees to attend.

Science might have been the subject of the meetings, but the subject of the emails was money.

When some drug companies balked at the $20,000 fee to attend the meeting, the organizers were firm. “20k is small change, and they can justify it easily if they want to be at the table,” one professor wrote to the other after an Eli Lilly representative objected to the price. “Everybody has been very happy with [the meetings] and they are getting a huge amount for very little money (impact on FDA thinking, exposure to FDA thinking, exposure to academic opinion leaders and their expertise, journal article authorship, etc.) and they know it,” according to The Post.

In his interview with the paper, the professor said that the costs of running such a meeting could run as high as $150,000, and they never knew how many sponsors they could attract. To make its gatherings more transparent, the group posted to its website copies of meeting presentations.

Still, some of the government officials seemed to find the whole thing fishy. One NIH staffer indicated that the fees paid by drug companies for private meetings could be criticized for influencing outcomes, and suggested holding the meetings at the NIH, and opening them to all interested parties to avoid the appearance of a “pay to play” process.

A lot of people thought this didn’t pass the smell test. None of them did anything about it.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
Washingtonian Top Lawyer 2011
Avvo Rating 10.0 Superb Top Attorney Best Lawyers Firm
Contact Information