It should come as no surprise to readers of this blog that we are delighted about the prospect of a new FDA commissioner in 2009 — one who we hope will put the interests of the people above those of large pharmaceutical companies.
We have also been pleasantly surprised to see the groundswell of public support for Pfizer whistleblower Dr. Peter Rost for the FDA’s top job. A clear industry outsider like Dr. Rost might seem a longshot to ultimately win the job — but then again, Obama was a longshot to win the presidency. And there are these three hopeful signs:
2. President-elect Obama’s chief of staff is a big fan of Dr. Rost.
3. Dr. Rost himself has jumped on the bandwagon, renaming his blog “Peter Rost for FDA Commissioner”!
Today, eDrugSearch.com officially endorses Peter Rost for FDA commissioner. We think he would bring the changes the agency so desperately needs.
On the occasion of our endorsement, Dr. Rost agreed to answer a few questions about how he would handle the commissioner’s job. He has some insightful comments on topics ranging from Canadian drugs to DTC advertising. Enjoy —
eDrugSearch.com: In the 1970s, the FDA had one of the highest public approval ratings among government agencies. Today, the agency’s reputation is a mess. What went wrong?
Dr. Rost: Same reason Wall Street’s reputation used to be great and is now a mess; they screwed up. The FDA is there to protect the public health, both by approving life-saving drugs and taking dangerous drugs off the market. They got too focused on approval and lost out on protecting the public against dangerous drugs (i.e. Vioxx); as a result we’ve had a number of scandals when the FDA has been perceived as being way behind the eightball.
eDrugSearch.com: What are the first three actions you would take as FDA commissioner, and why?
Dr. Rost: It is really impossible to answer without first having had a chance to evaluate the agency from the inside. In general terms, however, I’d like to reorient the FDA to focus on its primary customers . . . American citizens, instead of primarily serving the drug industry. That means the agency would focus not only on the fastest and most efficient processing of new drug applications, but would also ensure that unsafe drugs are taken off the market or labeling revised in a more timely manner. Both these objectives should be equally important.
I would also want to ensure that hundreds of unapproved drugs that are sold illegally as prescription drugs would be taken off the market, and that reimportation of drugs would become legal and regulated and appropriate safety measures taken to protect the public.
Finally, I’d want to bring the kind of internal and external accountability that normally exist within private corporations to a government agency and work for limitation of direct-to-consumer advertising, which is counter productive to efficient healthcare.
eDrugSearch.com: Are there concrete steps the FDA commissioner can take — directly or indirectly — to help reduce the cost of prescription drugs for American consumers? If so, what are these steps and how would they impact drug prices?
Dr. Rost: Support legalized and regulated reimportation of drugs, which would increase price pressure.
eDrugSearch.com: What is your view of the Wyeth v. Levine case? How do you believe the Supreme Court should rule and why?
Dr. Rost: My view is that no government agency, including the FDA, should be considered the equivalent of “God.” An FDA decision or lack of decision shouldn’t preempt a legal challenge and an FDA decision or lack of decision shouldn’t be used as a legal shield. The FDA doesn’t know everything, doesn’t have all information, only what it receives from drug companies and doctors . . . quite frankly, a decision in favor of preemption would be a disaster for American consumers.
eDrugSearch.com: What should the FDA do about direct-to-consumer drug advertising? Is there a role for consumer advertising of prescription medications — and if so, what should that role be?
Dr. Rost: I used to be in favor of DTC and a “free market” but a free market requires informed consumers. Most of them don’t have medical degrees; hence, most of them are not qualified to judge and make decisions based on DTC advertising and, hence, DTC advertising is not part of a “free market” — it is part of manipulation of consumers who don’t know better and doctors who give the patient whatever they ask for. DTC advertising is not in the best interest of evidence-based healthcare or the American consumer.
eDrugSearch.com: Are there ways the FDA can leverage Health 2.0 and other technologies to do its job better?
Dr. Rost: Yes. We are still in the Stone Age when it comes to optimizing use of eHealth, sharing information and medical collaboration and education. Too big a topic to get into detail.
eDrugSearch.com: What would you do as FDA commissioner regarding Canadian drug reimportation?
Dr. Rost: I’m in favor of regulated and legalized reimportation with access to these drugs through regular brick and mortar pharmacies. Today we have a very dangerous system, the Wild West. We need to protect consumers from illegal and misbranded drugs sold by Internet pharmacies. The only way to do it is to legalize and regulate this trade.
eDrugSearch.com: President-elect Obama has been a vocal advocate of Canadian drug reimportation. Apparently in response, Big Pharma and its proxies have been waging a renewed battle against reimportation in the media. Specifically, opponents of reimportation make the case that the FDA lacks the necessary staff and other resources to effectively regulate drugs coming in from Canada. What do you think of this argument?
Dr. Rost: That’s BS, like most of what Big Pharma has been saying in respect to reimportation. In Europe this has been done for 20 years with no major staffing issues.
eDrugSearch.com: Opponents of drug reimportation also claim that drugs coming into the United States from Canada do not meet the same standards as the drugs dispensed to Canadian residents. What do you think of this argument? Can we trust the Canadian government’s licensing procedures to protect the safety of U.S. consumers? What should be the FDA’s role in this issue?
Dr. Rost: Untrue. We can trust both Canada and Europe, since they use drugs from the same manufacturers and have stringent approval procedures. In fact, drugs from these countries may be safer than U.S. drugs, since we have a completely fragmented, state-based system regulating drug trade and wholesalers with lots of entry points for counterfeit drugs. The FDA’s role should be the same as for any other drug, ensuring safety of the drug supply.
eDrugSearch.com: eDrugSearch.com is delighted to endorse you for FDA commissioner! Any final thoughts for our readers?
Dr. Rost: Well, if Obama really is looking for CHANGE what better way to do this than to appoint a candidate who has already shaken up the drug industry?
In the end, we need an FDA accountable to the public, ensuring not only availability of life-saving drugs but also better protecting us against dangerous drugs.
We’ve had enough of tainted advisory boards and people who scratch each others backs, I think I could bring in some fresh air and sunlight.
The FDA is never going to be perfect, but we can all agree that this is one government agency which could do a lot better. The American public deserves better and so do all the great FDA staffers. I don’t think FDA employees are the problem, I think the issue we’ve had is a lack of leadership at the top and we need to bring in someone who has the guts to do what it takes and the vision to know that nothing is ever impossible.184