Pay for Play Scandal Brewing at FDA

Do you want to impact FDA thinking for a mere $20, 000?

That’s what two professors and FDA advisors asked drug companies when they offered to hold closed door meetings to develop consensus statements on regulatory policy for pain medication. FDA officials, according to the Washington Post, who regulate painkillers, sat on the steering committee of the panel, which met in private, and co-wrote papers with employees of pharmaceutical companies.

Pay for Play Allegations

This “pay to play” allegation was first uncovered in hundreds of emails discovered as a result of a Freedom of Information Act request by the watchdog group, Public Citizen. The discovery was followed by stories in early October in the Washington Post and MedPage Today.

Those stories got the attention of West Virginia U.S. Senator Joe Manchin who on October 9, 2013 demanded that the FDA turn over records of all meetings held with the drug companies.

In a letter to FDA Commissioner Margaret Hamburg, M.D., Manchin 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, ” wrote Manchin. He also charged 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.

Information Demanded From FDA

Manchin also demanded that Hamburg 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.”

The information Manchin wants from the FDA includes all the meetings described in the Washington Post article, as well as all information related to the meetings organized by Professors Robert Dworkin and Dennis Turk that involved the FDA. He also wants a list of all the companies and amounts they paid to attend the meetings.

Furthermore, he wants all emails written by the professors and Deputy Commissioner Douglas Throckmorton regarding these meetings and a list of all former FDA employees who left the agency to go to work for any of the companies that paid to attend the meetings.

Alexander Gaffney, news editor of Regulatory Focus wrote on October 10, 2013 that Manchin’s request would presumably include nearly every major conference attended by FDA. For example, the September 2013 AdvaMed conference, which saw attendance of numerous FDA staff, has standard registration rates for the full conference ranging from $995/$1, 595 to as high as $2, 595.

Gaffney wrote that is uncertain if FDA maintains or even collects this information. Gaffney 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.

A Clear Conflict of Interest

In his letter to Commissioner Hamburg, Manchin wrote that the allegations of improper relationships between the FDA and the pharmaceutical industry, “clearly demonstrate a conflict of interest by allowing pharmaceutical companies to have undue influence over the FDA’s decision making process.”

According to reports, continued Manchin, the two medical professors organized a panel in consultation with the FDA on how to test the safety and effectiveness of painkillers.

“According to e-mails between these two professors, pharmaceutical companies paid as much as $25, 000 each to have a seat at the table with FDA officials. When challenged by the companies on the cost, one of the professors responded that ‘20k is small change, and they can justify it easily if they want to be at the table.’ The professors continued to justify the high cost of admission to these closed-door meetings by pointing out that the pharmaceutical companies are “impact[ing] FDA thinking…for very little money.”

According to the Washington Post story, the agency told the newspaper that FDA officials did not benefit financially from their participation in the meetings. But two FDA officials later went on to work as pharmaceutical consultants and the e-mails portray an agency that, by allowing itself to get caught up in a panel that seemed to promise influence for money, had blurred the line between the regulators and the regulated.

In a statement, the FDA said “we take these concerns very seriously.” But, it said, “we are unaware of any improprieties” associated with the group.

Deputy Director Throckmorton said in an interview that strict rules of transparency and funding apply to the public-private partnerships that the agency engages in and that these efforts are important for the government and the industry.

But the group in this case was not initiated by the FDA, he said, and so was a private partnership to which those rules did not apply.

“There are rules in place for us to have these discussions, ” Throckmorton said. This group “was set up as a private group.”

The group was organized by the two medical professors, Dworkin of the University of Rochester and Turk of the University of Washington, and the e-mails for the most part describe their efforts at financing and organizing the group’s meetings.

Senator Scoffs at Agency “Who Me?” Defense

The Senator scoffed at Throckmorton’s assertion that because the panel was not initiated by the FDA, the rules prohibiting “pay to play” did not apply.

“I find that claim questionable and truly hope that the FDA will rethink their extremely misguided policy on this matter.”

He added that if the FDA is seriously alleging that its conduct is proper and that payments by the pharmaceutical industry to participate in closed-door advisory panels are not impacting its decisions, then the FDA should have no problem disclosing the requested information to his office in a prompt manner.

Promoting Public Health and Painkillers

Manchin reminded the Commissioner that her job is to promote public health and that task requires the agency to evaluate scientific data and put the public first. “These recent reports raise serious doubts about the FDA’s ability to make objective and scientifically based decisions regarding the proper treatment of prescription painkillers. Even worse, when challenged by another federal agency, the National Institutes of Health, on the stigma of this ‘pay to play process, ’ the FDA balked and continued with the arrangement.”

The painkiller industry is a booming business, wrote Manchin, with profits growing to $9 billion in the U.S.

As the painkiller market grows, continued Manchin, so does the epidemic of addiction and abuse. “Recent data from the Centers for Disease Control (CDC) demonstrates the role that opioid pain relievers play in overdose deaths. The CDC study showed that drug overdose deaths increased for eleven straight years since 1999. Sixty percent of the drug overdose deaths (22, 134) involved pharmaceutical drug products, and prescription drug products containing oxycodone, hydrocodone, methadone and others represented three-quarters of those deaths (16, 651). This is a problem that the FDA must address.”

Manchin’s Crusade

Manchin has been urging the FDA to reschedule hydrocodone combination drugs from Schedule III to Schedule II. “In spite of these conversations, I continue to be frustrated with the amount of time the FDA has taken to properly schedule these drugs. It has been 4 years since the second petition requesting that the FDA and the Drug Enforcement Administration (DEA) evaluate the proper scheduling of hydrocodone combination drugs. Even more concerning, it has been over 8 months since I testified at the Drug Safety and Risk Management Advisory Committee (DSaRM) where the FDA’s own advisory panel, consisting of leading scientists and researchers in the field, overwhelmingly voted to recommend rescheduling hydrocodone combination drugs.”

The FDA, according to the Washington Post has been criticized for failing to take precautions that might have averted the epidemic of addiction to prescription drugs including Oxycontin and other opioids.

“These e-mails help explain the disastrous decisions the FDA’s analgesic division has made over the last 10 years, ” said Craig Mayton, the Columbus, Ohio, attorney who made the public records request to the University of Washington. “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.”

Even as the meetings were taking place, the idea of FDA officials meeting with firms that had paid big money for an invitation raised eyebrows for some. In an email 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.”

In perhaps an unrelated reaction, Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research reported said that agency will re-classify hydrocodone-based painkillers, such as Vicodin and Lortab, as a Schedule II substance. Currently hydrocodone combinations are classified as Schedule III.

Well played Senator. But we still want to see the evidence from the meetings.