US Food and Drug Administration advisors have recommended a ban on the direct-to-consumer advertising of COX-2 inhibitors, after the agency concluded that the drugs – made by Pfizer and Merck & Co – are associated with an increased risk of cardiovascular side effects [[21/02/05a]].
On Friday, an FDA advisory panel recommended Pfizer’s Celebrex (celecoxib) and Bextra (valdecoxib), as well as Merck’s already withdrawn COX-2 inhibitor Vioxx (rofecoxib), should carry a “black box” warning that they are associated with an increased risk of heart attacks. Similar restrictions have also been implemented in Europe [[18/02/05a]]. However, the panel also voted that Vioxx should be returned to the market, in a move which could help Merck in ongoing legal disputes alleging damage from the drug.
In the latest development, the FDA advisory panel voted to restrict DTC advertising for the COX-2 inhibitors completely or, if that proved legally impossible, to allow them only if explicit warnings were included or if separate ads devoted to potential adverse events were also run.
Before the much publicised heart concerns, Celebrex and Vioxx to achieve sales in excess of $2 billion dollars apiece, and DTC has been cited a strong driver for the sales growth of COX-2 inhibitors, and the severity of the backlash to Vioxx after its withdrawal.
In the last few weeks, Pfizer has been rapped by the FDA’s Division of Drug Marketing, Advertising and Communications, which found that television and print DTC advertising for its COX-2 inhibitors and made unsubstantiated safety and efficacy claims, amongst other issues. The company was forced to withdraw the ads [[21/12/04b]], [[13/01/05c]].
The FDA said it did not believe it had the power to ban DTC ads for drugs, but might request that companies stop marketing drugs in this way.
