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In 'Pay-for-Access' Story, Could FDA Be Experiencing its First Scandal of 2013?

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By Alexander Gaffney, RF News Editor

Ten months into this year, and the US Food and Drug Administration (FDA) may finally be on the verge of stumbling into something it has yet to be embroiled in this year: scandal.

Background

On 7 October 2013, The Washington Post and MedPage Today both published accounts of what they said were meetings between members of the pharmaceutical industry, academics and FDA at which the three attempted to develop consensus statements on regulatory policy for painkiller medications.

The problem: Pharmaceutical companies had been requested by the conference organizers to pay a hefty sum of $25,000 per company to attend the meetings. The implication from both articles was that the arrangement had been pay-to-play, with pharmaceutical companies justifying the expense as a means of helping shape policy behind the closed doors.

The watchdog group Public Citizen, the group whose Freedom of Information Act requests had generated the information that uncovered the story, said the entire matter "warrants an independent investigation."

Letter from Manchin

And at least one senator agrees with that sentiment. In a letter sent to FDA Commissioner Margaret Hamburg on 9 October 2013, Sen. Joe Manchin (D-WV) called for a "full investigation" of FDA's actions and those of its personnel in light of the reports' findings.

“I am gravely concerned by the allegations of ‘pay to play’ between the FDA and pain medicine companies and am calling for a full investigation to see how deep this goes,” said Manchin. The senator also raised his views that the collaboration between industry and FDA could have resulted in the agency delaying a decision to reschedule hydrocodone "even after their own expert advisory panel recommended it."

"It is a shame that some of these companies were able to influence the FDA’s decision with a $25,000 contribution, while West Virginian families are destroyed by the addiction these pills cause,” he added, seemingly escalating the allegations to an accusation.

Details, Details…

Manchin's letter also calls on Hamburg to release information regarding the details of all meetings, including all conference panels and conferences at which "payments over $1,000 were made to the FDA or the organizing entity."

This would presumably include nearly every major conference attended by FDA. For example, the Advamed 2013 conference, which saw attendance of numerous FDA staff in September 2013, has standard registration rates for the full conference ranging from $995/$1,595 (early/standard registration) to as high as $2,595.

In addition, the letter calls for FDA to release information about the attendees of those conferences, as well as the amount they paid. It is uncertain if FDA maintains or even collects this information. Other similar information includes a list of all employees who have left the agency to go work for a company that paid to attend meetings that the staff member attended, and the total cost of meetings attended broken down by venue and food costs.

Focus reached out to several people with experience scheduling meetings with FDA staff. None could recall having received requests from FDA for any information outside of copies of the registration form and the cost of the conference to attendees.


Letter from Sen. Manchin




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