Pharmalot: Why did you pursue such a bill? What's the point? Catania: I've had other big pharma bills. One was about transparency for pharmacy benefit managers and another, which wasn't successful, about excessive pricing. But I've also been concerned with safety and I feel the federal government is asleep at the wheel. There's an onslaught of marketing and DDMAC (the FDA division that monitors promotional activities) sends letters and they're sometimes ignored. Or there's a slap. All I'm trying to accomplish is to give citizens a fair chance when it comes to the kind of information that is disseminated. This is one way.
Pharmalot: I've read each rep will have to pay $2,500 for a license and have at least a college degree. How'd you come up with that. Catania: No, the $2,500 figure is wrong. It's absolutely ridiculous. Physicians only pay $500 for a license and it will have to be decided by the Board of Pharmacy. And we never insisted on a college degree, only a certificate from an institution of higher learning. That also has to be worked out.
Pharmalot: Procedural matters aside, how is this supposed to work in the real world? Catania: Right now, if a physician or prescriber feels a sales rep has been offering false or misleading information or efforts, nothing may be said. But going forward, the physician will have a place to go. They can't go to DDMAC. And so our Board of Pharmacy is going to be charged with creating a code of conduct and enforcing regulations...There'll be the usual process where the board determines those things, public hearings, for instance. And pharma can be part of that process should they wish to comment.
Pharmalot: Sales reps are under a lot of pressure to make numbers. If they don't make them, they can be gone. And some docs may not be too concerned with what they hear, anyway. How do you address that? Catania: I'm not saying the bill is perfect. We have a big task ahead of us and industry will do everything it can to make sure we're not successful. But there is a breach between ethics and practice, and we're trying to close that breach. We're just trying to move the ship in the direction of greater transparency and a less paternalistic system....
...One thing to remember is that we're on the corner of Main Street and Main Street - much of the country pays attention to what happens here. And with industry exerting so much influence on the federal government, the states are increasingly left to their own devices. So this may start a trend with states pursuing similar legislation.
Pharmalot: You expect the mayor will sign this? Catania: Yes, we - the council - received two letters of support. From there, Congress has to approve, but I don't anticipate a problem. So I would expect the bill to become law within three to six months. And then the test begins.