Glynis Board Published

Manchin calls for invesitgation of FDA


U.S. Senator Joe Manchin (D-W.Va.) Wednesday sent a letter to the Commissioner of the Food and Drug Administration informing them he will be calling for a full senate investigation into allegations of unholy links between the pharmaceutical industry and FDA officials overseeing safety regulations of painkiller medicine—this in light of a recent report that West Virginia has the highest drug overdose mortality rate in the United States.
 The Trust for America’s Health released a report earlier this week that says over the past decade, overdose deaths in WV have increased more than 600 percent. Rich Hamburg, the Deputy Director of the Trust for America’s Health, largely blames access to drugs like Oxycontin, Vicodin, Xanax, Ritalin and especially hydrocodone.

This report coupled with a story in The Washington Post which alleges that private companies paid as much as $25,000 to participate in FDA advisory panel discussions on federal regulations for prescription painkillers, has Senator Joe Manchin calling for action.
“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 Senator Manchin. “If these allegations are true, they explain why it has taken the FDA almost a year to reach 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.”

Manchin sent a letter to Commissioner Margaret Hamburg, outlining his concerns and requesting more information about the meetings that have taken place:

Dear Commissioner Hamburg:   I write regarding recent reports describing the improper relationship between the Food and Drug Administration (FDA) and the pharmaceutical industry. Specifically, private companies have paid thousands of dollars to participate in FDA advisory panel discussions concerning federal regulations for prescription painkillers. These allegations clearly demonstrate a conflict of interest by allowing pharmaceutical companies to have undue influence over the FDA’s decision making process. I plan to call for a full congressional investigation into this issue to determine whether these relationships have impacted the FDA’s rescheduling of hydrocodone combination drugs.   According to reports, 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 professor 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.”   The FDA is responsible for protecting and promoting public health through the regulation and supervision of various products, including painkillers. This task requires the FDA 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, with profits growing to $9 billion in the United States. As the painkiller market grows, 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.   As we have discussed on many occasions, I have 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.   These press reports raise troubling questions about the FDA’s delay in issuing a recommendation regarding this petition. I truly hope that the FDA is not allowing their relationship with the pharmaceutical industry to influence their duty to protect the American public.   Mr. Douglas Throckmorton, a deputy director of the agency, said 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.   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 is not impacting its decisions, then the FDA should have no problem disclosing the following information to my office in a prompt manner:     The location, date and time of all meetings, discussion panels and conferences attended by FDA personnel where private companies, individuals and/or interest groups were able to attend if payments over $1,000 were made to the FDA or the organizing entity. Examples of these meetings, discussion panels and conferences were described in the Washington Post article “Pharmaceutical Firms Paid to Attend Meetings of Panel that Advises FDA,” Peter Whoriskey, Oct. 6, 2013; The location, date and time of all meetings, discussion panels and conferences organized by Professors Robert Dworkin and/or Dennis Turk that involved the FDA; A list of all companies that paid to attend the meetings, discussion panels and conferences described in the first bullet and the amounts that they paid; The topics of discussion at these meetings, discussion panels and conferences described in the first bullet; All recommendations arising from these meetings, discussion panels and conferences; All e-mails written by Professors Robert Dworkin, Dennis Turk, and Mr. Douglas Throckmorton or anyone else at the FDA regarding these meetings, discussion panels and conferences described in the first bullet; The total cost of each of these meetings, discussion panels and conferences described in the first bullet broken down by category of disbursements (e.g., food costs, venue costs, etc.); Any funds related to these meetings, discussion panels and conferences described in the first bullet that directly went to the FDA or any individuals at the FDA; All individuals who attended these meetings, discussion panels and conferences described in the first bullet; A list of all former FDA employees who left the FDA for employment at any company that paid funds to attend these meetings, discussion panels and conferences described in the first bullet. I respectfully request responses to these requests in a prompt and timely manner. I look forward to your answers.  

Manchin said he’s especially frustrated with this recent report and news story because he hasn’t been able to get significant progress with the FDA in getting hydrocodone reclassified as a Schedule II narcotic—which would classify it as having “a high potential for abuse which may lead to severe psychological or physical dependence.”

“Everybody on the front lines, everybody from drug treatment, everybody in the hospitals, law enforcement, totally support rescheduling hydrocodone from Schedule III to Schedule II,” said Manchin

He said that action would drastically reduce the amount of pills distributed, while assuring patients who need the drugs would be able to get a 30 day supply with a possibility of a 90-day extension if a doctor sees fit. He says the only opposition to this change has come from pharmaceutical companies.