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Lawmakers Lean on FDA to Police Drug Advertising

May 8, 2008 | Parker Waichman LLP Last month, Congress asked the Food and Drug Administration (FDA) to speed its efforts in forcing drug companies to include safety-reporting information in television and radio ads.  Now, Congressional Democrats are placing more pressure on the drug industry's direct-to-consumer advertising following increased problems over the marketing of several popular drugs, including Vytorin, Lipitor, and Procrit.

Last year, Democrats lost a fight to increase government regulation of TV commercials for prescription drugs; however, recent controversies have helped Democrats on the House Energy and Commerce Committee.  Also, late last month, drug maker AstraZeneca Plc urged U.S. lawmakers to revive a program for drug makers who want to voluntarily submit their television commercials for regulatory review.  Congress created the program last year but it has not taken effect and lawmakers failed to give the FDA full authority to collect and spend industry fees to fund reviews.  Because the system is voluntary, FDA scientists are concerned it misses most adverse drug reactions.

Direct-to-consumer drug marketing nets billions in sales for drug makers and the television industry.  In 1997, the government relaxed TV and radio ads rules, allowing drug makers to shorten warnings on side effects in commercials; since then, pharmaceutical makers have spent about $14 billion on broadcast and cable TV ads for prescription drugs, making that a major television revenue stream.

A subcommittee led by Michigan Democrat Bart Stupak scheduled a hearing today entitled "Direct to Consumer Advertising:  Marketing, Education, or Deception?"  Stupak says his purpose is to “lay the groundwork” for future legislation to tighten controls on drug marketing, which includes giving the FDA the ability to force changes in TV drug ads before broadcast.  "The drug and TV and cable industries have formed a cabal here to protect their revenues," said Gene Kimmelman of Consumers Union, an advocacy group looking for stricter limits on direct-to-consumer drug marketing

Merck & Co. and Schering-Plough have been harshly criticized for their promotion of cholesterol drug Vytorin and not disclosing a study questioning Vytorin’s effectiveness.  Pfizer Inc. featured Robert Jarvik, the inventor of the artificial heart in commercials in which “he appears to be giving medical advice,” according to the committee, which suggests the ads are misleading.  Jarvik in neither a cardiologist nor a practicing physician.

Stupak says Procrit marketers Johnson & Johnson, and its subsidiary Ortho Biotech, broadcast ads promoting Procrit as an anti-fatigue medication.  Procrit was not approved for this purpose and the FDA repeatedly called for the company to revise its ads.  "They advertised this for seven years," said Stupak, calling the actions a violation of off-label-use prohibitions.  Stupak said political appointees leading the FDA's legal advisory team effectively shut down the FDA's marketing regulators during the current administration and the FDA's letters to J&J and Ortho Biotech complaining about the TV marketing stopped in 2001, just before the FDA instituted a policy of first sending warnings to companies through the FDA chief counsel's office for review.  The company stopped running the TV ads in 2005 and print ads in 2006.  Procrit was later linked to increased risk of tumor growth in certain patient and a panel of experts advising the FDA questioned if Procrit was being overused in cancer patients.

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