The Prescription Drug User Fee Act (PDUFA) reauthorization, passed last week by the Senate (but not yet by the House of Representatives) contained a wide variety of sections unrelated to FDA User Fees. One of these, section 519 would permit the FDA to impose monetary fines for pharmaceutical companies issuing “false or misleading” drug ads. The maximum fine for a first violation in a 3-year period would be $150,000, and a maximum of $300,000 for any additional violations in a 3-year period.
Back in 2005, PAL called for the FDA to seek from Congress the authority to issue civil monetary penalties, in our testimony at the FDA’s hearing on Direct-to-Consumer Advertising. Without such authority, the FDA’s power to regulate DTCA is essentially limited to issuing unenforceable “untitled” and “warning” letters. Given the number of recidivists in this area (see US PIRG’s report, “Turning Medicine Into Snake Oil“), this power is akin to an old joke (from Robin Williams, I believe) about unarmed British police shouting at a fleeing felon, “Stop, or I’ll Shout ‘Stop’ Again!”
It’s clear that for any standards regarding drug ads to be taken seriously, the FDA needs the ability to enforce them. Whether the fines included in the Senate’s PDUFA bill do the trick, however, is unclear. The fines listed are maximums, and even those are likely to be hotly contested by any companies upon whom they are sought to be imposed. It is uncertain whether fines in this amount would have any deterrent effect, or whether they might be, like much much larger US Attorney settlements recently reported upon here in this blog, slaps on the wrist. $150,000 is probably not far from the cost of a modest advertising buy on a major network, and certainly a small amount compared to even short-term sales of any blockbuster drug.
At the least, however, the notion that the FDA needs greater authority and powers to regulate drug advertising is now part of the public debate. And that is certainly a good thing.