Waxman Targets DTC
Henry Waxman is not making a secret of his desires to restrict DTC. Long a critic, Mr. Waxman will now have a friendly Congress and White House behind him. In a speech to the Prescription Project on 12/8, a group looking to restrict marketing to physicians and consumers, the Congressman told the attendees he wants to restrict DTC for new some new products for up to two years.
The idea of a moratorium on advertising for new products has been discussed for several years. The drug companies and advertisers successfully prevented it from happening in the current Congress. The new Congress will have much stronger majorities for anti-DTC forces and Waxman will have support to pass something more restrictive. Currently a few drug companies have agreed on voluntary delays in DTC up to one year but Congress wants more.
The moratorium Waxman proposes is not automatic nor will it apply to all new drugs. That power will be left to FDA to use if needed. I expect that any new class of drug will fall into the mandatory moratorium category. I doubt it will be used for new versions of existing classes of drugs. Realistically then, we can expect a moratorium to be used infrequently, given the rarity of new drug classes.
Of course, the advertising industry will fight tooth and nail to prevent any imposed moratorium policy instead wanting to keep it voluntary. The ad industry is afraid even a rarely used moratorium could quickly become a widely used one and for more than two years. Ad lobbyists will use prior restraint of commercial speech as the defense. They may win in court if it goes that far given precedent on commercial speech. My guess is the drug companies will agree to extend the moratorium period for new drug class advertising long enough to satisfy the FDA and Congress. Thus, it may be a power never imposed on the drug companies even if given to the FDA by Congress. I am sure drug companies will be delaying DTC longer so as not to anger a more powerful FDA. Drug companies know that FDA can delay new drug approval and will not let the use of DTC be a barrier to that approval.
I have never been opposed to a reasonable moratorium period. Critics have a legitimate point that many side effects do not appear in small clinical studies and take a year or more to be seen in actual use post launch. A moratorium would theoretically slow both consumer awareness and demand allowing physicians more time to gradually ramp up use. On the other hand, that also means a breakthrough drug would be kept out of public knowledge longer. The issue is whether safety conservatism trumps faster adoption of a novel drug. It is not so easy to assume that delays in consumer awareness really are in the public interest. It is true that some lives may be saved by allowing a longer time for discovering side effects. Lives may be lost, however, by delaying a fast roll-out of a good drug.
I hope whatever Mr. Waxman does recognizes the consequences of insisting on moratorium periods of two years. The trade-off between safety and better efficacy are not easy to determine. What is needed is pragmatism between critics and drug companies. So far Mr. Obama seems very pragmatic, but I fear some in Congress have been salivating at the prospect of sticking it to drug companies. I hope Mr. Waxman can see both sides of the arguments and the unintended consequences of holding up consumer information for long periods.
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