Tuesday, October 08, 2013

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 are open to you that are not open to the non-paying public. For example, if a pharmaceutical company would like to have a sit down meeting with the FDA, the agency will accommodate the paying "client." These are closed door meetings held at FDA headquarters, I presume, and not at fancy hotels.

FDA officials routinely join pharma companies or related vendor organizations after serving enough years as a public employee to be assured a nice pension. "After 11 years at the FDA, Deborah Autor, who is deputy commissioner for global operations and policy, is leaving to take a job with Mylan, one of the largest generic drugmakers," reported Pharmalot recently (here). I'm not sure 11 years is long enough for an FDA employee to become vested, but you get the idea.

Money also flows the other way -- from vendors to pharma. Well, not exactly money, but "in-kind" amenities like free stays at golf resorts. For example, the business model of at least one conference organizer that I will not name charges vendors $20,000 to $30,000 to attend a meeting where they participate in several one-on-one 15-minute sessions with pharma product managers who have all their expenses paid. In other words, in exchange for hearing pitches from a few vendors, the pharma guys get free room and board at a nice golf resort -- they may even get free golf rounds.

This is just how business is done in the FDA-Pharma world. Although FDA attendees at these meetings might have to "brown bag it," they get exposure to drug industry people who may one day recruit them to join the "dark side." That's the way FDA operates. In fact, it's the way America works, if you consider our legislators who often take cushy jobs with industry after serving in office and being assured lifetime benefits even when the government is shut down. Investigate THAT!

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