Pay To Play? Drugmakers Paid To Attend Panel That Advised FDA

How much impact did Immpact have in shaping FDA thinking on testing the safety and effectiveness of prescription painkillers? For those unaware, Immpact is a behind-the-scenes panel run privately by a pair of academics, who have regularly invited agency officials, academics and drugmakers to Washington DC hotels for brainstorming sessions on fine tuning clinical trials. The panel acronym stands for Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (look here). The drugmakers, however, were required to pay big fees to participate – as much as $35,000 to attend a single meeting. And this has raised uncomfortable questions for the FDA, because the arrangement smacked of a ‘pay to play’ atmosphere that could benefit the pharmaceutical industry, according to e-mails that a lawyer obtained through the Freedom of Information Act and then provided to The Washington Post, The Milwaukee Sentinel-Journal and MedPage Today. “These e-mails help explain the disastrous decisions the FDA’s analgesic division has made over the last 10 years,” Craig Mayton, the Columbus, Ohio, attorney who made the public records request to the University of Washington and provided them to the newspapers. “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,” he told the Post. One initiative that emerged from the meeting Is the FDA’s new ‘enrichment enrollment’ gui...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs