Waxman, BMJ question new-drug DTC

Rep. Henry Waxman picked a good time to call for new restrictions on drug advertising. The Congressman--who'll take over as chair of the powerful House Energy and Commerce Committee in 2009--wants to give FDA the power to ban direct-to-consumer ads for new drugs. The ban could last as long as three years for individual meds, if the FDA considered it necessary to protect public health.

Meanwhile, a new study in the U.K. journal BMJ found that quick rollout of mass-marketing on new meds increases the risk that large numbers of patients will be exposed to unknown side effects. The study's main point was that drugs approved closer to deadline are more likely to need strong safety warnings later, but it also focused on the way marketing can quickly ramp up use of a new drug.

Which is exactly Waxman's point: "It is in these first few years of a drug's life that drug companies often aggressively market their products and engage in direct-to-consumer advertising," he said at a recent conference. "This increases the number of consumers exposed to safety risks of new products long before those risks are truly understood."

The BMJ study's lead author, Dr. David Kao, thinks drugmakers should use their vaunted marketing abilities to help monitor drug safety once meds have hit pharmacy shelves. But the industry group PhRMA doesn't sound like it's interested in taking any advice from Kao; it was too busy criticizing his study. According to PhRMA, marketing doesn't even play a dominant role in doctors' prescribing decisions. That's good news for Waxman. If marketing isn't that important, banning new-drug ads for up to three years shouldn't be a tough sell. 

- check out Big Pharma's Top 13 Advertising Budgets
- see the Waxman story at Pharmalot
- check out the BMJ post at BNet