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


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

Do you expect other changes in Medicare?

There are people who are sort of enemies of the whole thing, who tried to kill our bill. And now they're coming back trying to have the government negotiate. How much better can the government negotiate when the plans are negotiating the average price of a drug down between 18 and 23 percent and generics down by around 50 percent? You can't do much better than that. There are some people who think the government can negotiate, but we didn't want the bureaucrats between you and your medicine cabinet.

We have the example of the Veterans Administration administering drug prices. But you find out that the VA doesn't pay for every drug. One thing we wanted to do was make sure that every Medicare drug-plan formulary had every drug category in it—so that the doctor could prescribe what he thought was best for the patient.

Imports produce competition

Despite the success of Part D plans negotiating lower prices, you have raised concerns about drug prices being too high.

That comes from a lack of competition because we don't allow importation of drugs. I believe in the importation of safe drugs, with FDA approval of the manufacturing and distribution systems in other countries—just like we do for meat we import from other countries.

But FDA says it's impossible to regulate drug imports.

We don't say that about meat. And we can do it even better with drugs because we can put in computer chips that determine if they're fake or not when they come through a port of entry. We ought to be using these new technologies for the benefit of our consumers.

Manufacturers say it will take 10 or more years to do that.

Well, industry doesn't like competition. One problem is that our consumers are paying for all the research that goes on. But why not have the Germans and Canadians pay for some of the research? If we have competition to drive down the price of drugs in this country, and the drug companies then didn't have enough money for research, they wouldn't sell the drugs so cheaply to the Germans and Canadians.

If you were head of FDA, what is the first thing you would do?

I'd have a Rose Garden ceremony for all the whistleblowers within my agency. No commissioner can know where every skeleton is buried, so he ought to honor those who are patriotic enough to make sure the laws are faithfully executed and the money is spent according to Congressional intent.

The whistleblower law should be strengthened, but it's doing a great deal of good right now. There's a great deal of pressure to get along in any organization. Look what they do to scientists within FDA. They wouldn't let one read a paper at a scientific gathering. Someone was going to get something published in a journal, and they wouldn't let him. What is this—a bunch of school kids? They're grown adults sworn to carry out the Constitution.

How else could the next commissioner restore public confidence in FDA?

Make sure the Office of Drug Safety is not in any way under the thumb of the Office of New Drugs. And I would make sure there's a [record] of every communication that every employee has with a company, that it's transparent.

Does disclosure address your concerns about conflicts of interest?

I think disclosure goes pretty far in dealing with these issues. For members of FDA advisory groups, their relationships with any company should be made entirely public. If you can get the expertise that you need, you shouldn't have any of these people on your advisory committees. But if you can't get that expertise and you need them, then everybody ought to know that doctor X was getting this sort of money from this company to do this sort of work. You can let him render his advice, but it must be entirely transparent on any relationship.


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