Pharm Exec Q&A: A Soft Spot for Whistleblowers - Pharmaceutical Executive

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Pharm Exec Q&A: A Soft Spot for Whistleblowers
FDA's most aggressive critic in Washington is Iowa Senator Charles Grassley. In this exclusive Pharm Exec interview, he explains where the agency goes wrong—and what he would do to fix it.


Pharmaceutical Executive


Your drug-safety bill also proposes changes in how FDA regulates drug advertising. Are you concerned that DTC ads raise safety issues?

I've watched so many of these commercials and feel that the dangers [of drugs] are not as obvious as they ought to be. When the person presenting the commercial gets to the lines about safety, they go very very fast. It just seems to me that that compromises the safety issues of some drugs. And so I'm not looking at it from the standpoint of whether there ought to be drug advertising or not. I'm looking at it from the standpoint of it being effective advertising regarding drug safety. We have asked the Government Accountability Office to examine DTC advertising on safety issues. A report should be out early next year.

Your legislation proposes a two-year moratorium on DTC advertising for new drugs, as well as specific language on safety in advertising. Would that address safety concerns?

Yes. It seems to me a natural extension of drug safety: If there's information going out on the use of a drug and there are some dangers connected with it, those dangers should be as prominent as the promotion of the uses of the drug.

Medicare success

You have been a major proponent of the Medicare drug benefit. Has it lived up to your expectations?

It has worked out better than we expected. Back during the negotiations in 2003, we were worried sick over how realistic it was to have a $35-a-month premium. But competition has brought premiums in at $23. We were worried about whether there would be enough plans, because in rural America we wanted to have competition and more choice. And now there are 44 plans in Iowa.

And then you even get added benefits. You know we have the problem with the doughnut hole. To fill it would have cost $400 billion dollars—twice as much as the rest of the program—to take care of 12 percent of the people. Now we have plans that don't have doughnut holes, and we didn't even force it on them.

Despite this good news, do you see aspects of Part D that need further improvement?

Pharmacists are not being treated right. There's no reason why these plans can't pay up within two weeks, so the cash flow is not so bad. I've sent letters to CMS [Centers for Medicare and Medicaid Services] proposing just that. If we don't get this done, we may lose a lot of community pharmacists.

Do you still support relief on the late-sign-up penalty?

It's needed because there are up to two million people who might want to join, and they can't sign up until November. So I'm willing to forego the penalty just once—not beyond this year—to get more people under the umbrella. Then you've got a better program that is more effectively financed. And I've introduced legislation to do that.

One success has been to encourage drug manufacturers to continue Patient Assistance Programs for Medicare patients. Do you feel that industry is fulfilling its promises in this area?

I think almost every company is moving toward cooperation in continuing their programs through the doughnut hole. I think our inspector general is trying to accommodate that. There are some companies more aggressively cooperating than others. Prior to the meeting we had in this room, around the first of May, we had the opinion that most of these companies wanted to get rid of the programs, that they didn't want to have anything to do with them. After our consultation with them, the companies are trying to accommodate the people who need the drugs but can't afford them. So I'd have to say that they're going in the right direction. What I see now is a healthy attitude on their part, and I think we've got the inspector general coming around to say it's legal. And I didn't have to get 51 votes to get it done.


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