The restrictions on direct-to-consumer advertising placed in the legislation to renew the prescription drug user fee program appear headed towards a showdown in the judicial branch after an attempt to remove them failed in a Senate committee.

During mark-up of the legislation in the Senate Health Committee April 18, Sen. Pat Roberts, R-Kan., offered an amendment that would have removed the section expanding FDA's authorities over DTC ads and replacing it with language that requires presubmission of ads and allowing the agency to fine firms for false and misleading ads.

The bill drafted by committee Chairman Edward Kennedy, D-Mass., would allow FDA to require general warnings about unknown drug risks and to block DTC ads for up to two years after a product's approval.

Endorsing the amendment, Sen. Richard Burr, R-N.C., said, "Everybody understands that [the current language] will be constitutionally challenged, and the likelihood is the companies will win that. Now the question is do you want to put everybody through that cost to do that, only to end up where we are today?" The amendment was defeated 10-12 on a party-line vote. Ranking member Michael Enzi, R-Wyo., who voted against several other Republican attempts to limit FDA's safety powers, joined the failed effort to rewrite the DTC language.

The advertising industry is even more pessimistic about the prospects in the House, where a version of the bill sponsored by Reps. Henry Waxman, D-Calif., and Edward Markey, D-Mass., calls for a three-year ban on ads (¹ 'The Pink Sheet' March 26, 2007, p. 5)

However, at an April 17 House Energy and Commerce/Health Subcommittee hearing, Chairman Frank Pallone, D-N.J., expressed concern about the constitutionality of such a ban, and asked if there is "something in between" a voluntary industry compliance program and a government moratorium.

Pharmaceutical Research & Manufacturers of America Deputy VP-Regulatory Affairs Alan Goldhammer said that industry's guidelines have "largely solved the problem." Consumers Union Senior Policy Analyst William Vaughan said, however, that preclearance powers were needed in light of continued violations such as a recently cited ad for Takeda's insomnia drug Rozerem (² Also see "Reminder Ads Stay Healthy In Canada Even As They Are Frozen Out Of The U.S." - Pink Sheet, 19 March, 2007., p. 21).

- M. Nielsen Hobbs (n.hobbs@elsevier.com) & Cathy Dombrowski (c.dombrowski@elsevier.com)

DTC Limits May Land In Court After Opponents Fail To Strip FDA Powers From Bill

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