Wednesday, November 26, 2014
Inquirer Daily News

FDA and pharma meetings - off to the side

Pharmaceutical companies paying into a fund to facilitate quicker drug approval is a problem, made worse by off-the-record meetings, brokered by researchers.

FDA and pharma meetings - off to the side

Among the many illogical aspects of American healthcare is that pharmaceutical companies pay fees to the federal government to help fund the process of drug evaluation at the Food and Drug Administration.

The FDA is supposed to protect citizens from bad food and drugs. This is what tax money is supposed to do, just like other sensible government functions.

The drug companies want the FDA approval for legal but also commercial reasons: If consumers think the government checked out the food and drugs, then perhaps the food and drugs are safe enough to consume.

But the drug companies would prefer the FDA just say, "Hey, that's great, go ahead and sell it." The drug companies don't want extra questions and they also don't want the FDA to take too long to give that stamp of approval. So, knowing that budgets are tight, they contribute grudgingly to the budget for testing.

That situation alone has obvious potential for conflict of interest.

The next step, or another step, was explained in a Washington Post story, which detailed the efforts of an Ohio researcher to expose a cabal between two medical professors, Robert Dworkin of the University of Rochester and Dennis Turk of the University of Washington, who solicited additional drug company money to convene a meeting with FDA officials. But this was not a public, on-the-record meeting. The link to the version in the Inquirer is here. The link to The Post story is here.

From The Post story, with FDA comment:

Douglas Throckmorton, a deputy director of the agency, 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.”

 

David Sell
About this blog
David Sell blogs about the region's pharmaceutical industry. Follow him on Facebook.

For Inquirer.com. Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Reach David at dsell@phillynews.com.

David Sell
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