Healthy Skepticism Library item: 13575

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

AstraZeneca Seeks FDA Revision to Bring Back DTC User Fee
FDA Week 2008 May 2
http://www.therapeuticsdaily.com/news/article.cfm?contentValue=1774715&contentType=sentryarticle&channelID=33

Full text:

Drug maker AstraZeneca is urging Congress to revive a program that would have let FDA collect user fees in exchange for reviewing direct-to-consumer advertisements. An appropriations bill killed the fee, but resurrecting it would require changes to the FDA Amendments Act.

AstraZeneca President Anthony Zook wrote in an April 24 letter to lawmakers that the user fee would have been “good for patients, good public policy, and a sensible way to help alleviate concerns that have been expressed about the tone and content of some DTC television advertising.” The letter was sent to Senate health committee Chair Edward Kennedy (D-MA) and ranking Republican Mike Enzi (WY), as well as House Energy and Commerce Committee Chair John Dingell (D-MI) and ranking Republican Joe Barton (TX).

Congress authorized the DTC user fee as part of FDAAA, but with a caveat that the program would terminate if FDA didn’t collect a certain amount in the first year. Later, the fiscal 2008 omnibus appropriations package blocked FDA from collecting any DTC user fees. So the program fell short of its FDAAA-mandated startup, and FDA pronounced it dead in January.

“It is unfortunate congressional intent was thwarted,” the AstraZeneca letter states. “More important, perhaps, it is unfortunate that Congress, FDA, and the biopharmaceutical industry were denied the opportunity to jointly support sound public policy on such a key policy issue.”

A spokesperson for Enzi said no such change in FDAAA has been discussed.

DTC advertising has come under heavy fire in the House since FDAAA passed. Energy and Commerce investigations have targeted campaigns for two top-selling drugs, Vytorin and Lipitor, and the companies that make those two drugs have both pulled their most controversial ads. It’s unclear whether that heightened scrutiny would make lawmakers less likely to re-authorize an industry user fee or create new pressure for FDA to review ads before they run.

Rep. Rosa DeLauro (D-CT), the chair of the appropriations subcommittee that funds FDA, was among the fee’s most prominent critics. She feared that it would give regulated industry too much power over the agency and gave FDA’s ad review shop an increase in appropriated dollars for 2008. Still, the increase amounted to less money than FDA would have gotten from user fees, and AstraZeneca noted in its letter this week that appropriations change every year.

“In the absence of dedicated appropriations … the aversion to user-fees by some members should not be a bar to enacting meaningful public policy,” the letter states.

FDA’s fiscal 2009 budget request proposed reinstating the DTC fee and pledged to work with Congress to ensure it could be collected next year.