Vowing new restrictions on DTC, Rep. Henry Waxman (D-CA) told consumer marketers that “When drug companies are permitted to oversell new products, the threat to the public is substantially increased.” Waxman, who has co-authored an aggressive drug safety bill that would give the FDA broad powers to curb advertising and other forms of promotion to consumers for new drugs, addressed the DTC National Conference in Washington last week. In a Q&A with aggrieved marketers, he conceded – despite an earlier assertion to the contrary — that ads might have some public health benefits, and said he is “not trying to eliminate that benefit.” “I do appreciate that people who see ads may go and get medical care for conditions they wouldn’t have heard of otherwise, but we have a bigger barrier to care which is in fact that we have so many people without health insurance, so they don’t go get any care until they end up in the emergency room.” But Waxman, citing advertising for Vioxx, said drug ads pose a threat to public health by driving demand for newer drugs which might pose as-yet unknown health risks. “What we’re offering is a way to balance these concerns,” said Waxman. “Certainly after a two- or three-year period, there can still be [undetected drug safety] problems, but when it’s a brand new drug and we don’t know the full extent of the problems that can come up with a larger population, we ought to be more careful, because the preapproval system is not failsafe and the postmarketing system is often nonexistent.” The Waxman-Markey legislation, dubbed the Enhancing Drug Safety and Innovation Act of 2007, would authorize FDA to ban consumer advertising for new drugs for up to three years. The bill, which places much harsher restrictions on manufacturers than its Senate counterparts, would also mandate FDA pre-clearance of all ads, require that ads and labeling carry an icon designating a new drug, and allow FDA to audit marketing plans and mandate specific language in ads. Waxman hopes to attach the bill to the upcoming PDUFA reauthorization. Waxman also zeroed in on Amgen’s Enbrel “Freedom” TV spots. FDA slapped the spots for overhyping benefits and asked Amgen to pull them in February 2005. He complained that companies are “being allowed to cherry pick” favorable clinical data to share with doctors while omitting less-favorable data, and said manufacturers typically shirk commitments to conduct post-marketing studies once their drug is on the market. Drug ads, he said “make [doctors’] lives more difficult” by prompting patients to pressure them for drugs, and doctors “are notoriously unconcerned about the price tag.” “That leaves the public picking up the tab for new and highly advertised prescription drugs,” said Waxman. Those working on physician-directed promotions shouldn’t get comfortable, either. Waxman said he was even more concerned about professional promotion, specifically citing meals, gifts and events for docs and their staffs. Jim Davidson of Davidson & Co. called Waxman a “veteran player” whom the industry “cannot underestimate” and warned attendees to get involved in countering the legislation now. “We are near a perfect storm,” said Davidson. “A lot of things have come together [in Washington] that put us in a very precarious position.” Staking out grounds for a constitutional challenge to Waxman’s legislation, Pfizer senior corporate counsel Arnold Friede said “The premise is that the legitimate objective of government is to control the demand of lawful products through suppression of speech.” That premise, he said, would not pass muster in the Supreme Court.
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