Pay to Play is the FDA - No, the AMERICAN - Way!

FoxBusiness asks if Pharma and FDA are too close for comfort in an interview (view it here) regarding how some some of the nation's leading pharmaceutical companies paid "entry fees running into the tens of thousands of dollars to attend invitation only conferences with FDA and NIH officials" (access the MedPage story here). Fox reporter/commentator Gerri Willis exclaims "this stinks!" and "we need an investigation to figure out exactly what's going on here." Pretty strong words from a Fox reporter/commentator.Obviously, however, there will be no investigation as long as the government is shut down.In an interview, Douglas Throckmorton, MD, the FDA's deputy director for regulatory programs, said FDA officials who attended such meetings were listening to scientists, not setting policy. "Pay-for-play is just not the way the FDA operates," Throckmorton said. "That's not part of the culture of the FDA."Not the way FDA operates? Doesn't FDA charge the drug industry "user fees" for drug approvals? In fact the FDA recently threatened a drugmaker with ban for not paying user fees. According to this FiercePharma Manufacturing story, "the FDA said that because the company has not paid its fees, its products are now considered misbranded, and that can lead to having them banned from the U.S. and seized if they show up at a border.Interestingly, user fees are the only money the FDA can continue to use during the government shutdown! Once you pay the piper, all sorts of FDA doors ar...
Source: Pharma Marketing Blog - Category: Pharma Commentators Tags: User Fees PDUFA FDA Source Type: blogs