Last Updated Dec 4, 2008 2:51 PM EST
BNET: Is this serious? Rost: Yes it's serious. Seriously, this is serious. I spent 20 years in the pharmaceutical industry, which is regulated by the FDA. I think I've been outspoken on a number of issues that are important to public health. I have in the past not only demonstrated outstanding performance within the industry, but I've also shown leadership when it comes to problems. I think the FDA right now is just like other parts of government, it badly needs change. We have a lot of good people at the FDA but the agency has been very much in the hands of the drug industry and they need somebody who can restore confidence in the agency.
BNET: Have you ever been to the FDA's building? Rost: No I have not.
BNET: Do you have any qualifications on the "food" part of the FDA? Rost: I don't have qualifications on the food side. Like many others who've been at the FDA usually you have qualifications in the particular area, in my case the drug business. I do have an MD, which is the health qualification that that prior commissioners have had.
BNET: Wouldn't you be conflicted in terms of dealing with Wyeth and Pfizer, both companies that you've sued in the past? Rost: When it comes to Wyeth I don't see any conflict because we have no ongoing issue. When it comes to Pfizer, if I did have ongoing issues at that time I would excuse myself from any decision-making that affected Pfizer.
BNET: What's going on with your two suits against Pfizer? (One is a federal whistleblower suit, the other is a New York state employment claim.) Rost: Nothing really new. We have started and are in the middle of discovery when it comes to the qui tam [whistleblower] thing; the employment suit is ongoing. Basically, discovery has been completed. We have a confidentiality order in place. It's simply easier if I don't discuss those issues.
BNET: Have you changed your views on reimportation since the drug scandals that came out of China? Rost: No. As far as I'm concerned it confirmed my view. I do believe that tainted drugs bought on the internet is a real threat to American consumers. And I do believe the only way to deal with that is to legalize reimported drugs so that consumers are not forced to to to the internet and buy drugs from unknown sources. In a legalized environment they'd be able to go to a regular pharmacy and buy reimported drugs with the same seal as any other drug.
BNET: What would be your No. 1 priority, commissioner Rost? Rost: It's a difficult question, because you can throw out a lot of different stuff. You need to get inside the agency and see how things are really working. My No.1 priority would be looking at resources in the agency and how they are spent, a top-down approach. Right now it appears to me it's just as hard to get a drug off the market as it is to get the drug approved. You'd have to look at how are the resources are divided, what resources a spent monitoring drugs on the market? In so far that Congress would pout forth new legislation on reimportation, or if we could use some existing legislation put forth but had been backdoored and required approval by the Health and Human Services secretary or the FDA, I would be in favor of working for safe, legal environment to reimport drugs.
I would be strongly in favor of limiting or stopping DTC advertisers. It's a manipulation of consumers that doesn't help the public. I also think we have a major problem with hundreds of illegal unapproved drugs, unlisted in the PDR, on the market today where the FDA claims they don't have resources to shut down manufacturers. It's quite amazing I've only learned about it recently myself.
I would not like to see a slowdown in the approval of new drugs. It's just as important as making sure that bad drugs are taken off the mkt.
BNET: How are you going to find extra resources to crack down on illegal drug sales in a time when tax revenues are reduced and deficits are up? Rost: If you talk about illegal drug sales as far as internet pharmacies, outside the jurisdiction of the U.S., you can't really do anything except provide a good viable alternative, which is to legalize reimportation. Unapproved drugs, that is something the FDA can go after today. I don't know why that doesn't happen. I know the FDA has been quoted saying they don't have resources. I spent these last 20 years in business. The one thing I learned which holds very true is the 80-20 rule. You get 80 percent of results from 20 percent of your spending. In corporations, in government agencies, you have enormous waste because people are so slow to focus on what's important and what truly makes a difference. It's easier to make tiny adjustments back and forth and you end up with what you see with GM and Ford right now. You just have to have the guts to do it.
BNET: You're from Sweden originally, and you still have a Swedish accent. Are you an American? Rost: Yes.
BNET: The last time I saw you, you were walking round Short Hills, N.J., in a Panama hat. Will you wear your Panama hat to work if you are made FDA commissioner? Rost: I think if I were to become FDA commissioner I would work very hard on restoring the reputation and integrity of the agency, and somehow I have a feeling that the Panama hat wouldn't be helpful.
BNET: If you get anywhere close to being nominated, people are going to look into your background and check you out. And they're going to find some racy things on your blog. Rost: I never posted anything that showed any nudity ... I've sometimes written about areas that deal with sex. From breast-feeding to other things. But I purposely stayed away from images that would be inappropriate
BNET: What about those items about the Merrill Lynch banker in Brazil who was filmed having sex on the beach? Rost: The story there was when Brazil tried to shut down the internet. It was about censorship.
BNET: Will you move to DC? You've got two kids in school. Rost: Sure. Hey I've been moving around my entire life so that's not an issue.
BNET: What else should people know about potential commissioner Rost? Rost: I think I'd be able to work both sides of the aisle.