Nicola Boyes: The FDA has come under criticism recently for extreme delays in approving new drugs for the market, is the criticism valid and if so how are the delays impacting on the US pharmaceutical industry at present?

Dr Alan S Louie: I think the question is actually somewhat more complicated than that. Yes there has been some slowing in the approval of drugs from the FDA, in part due to legitimate concerns in relation to drug safety. In that regard the FDA has been somewhat more cautions in its approach in moving many drugs forward to ensure there are no cardiac events.

New drugs in the cardiovascular space have been very much in the limelight so from that perspective, yes they have been slower in their approval with much of that slowing largely due to concerns over drug safety.

Some of the new drugs under review have also been ‘me too’ or combination drugs, in which case there has been difficulty in demonstrating that the drugs are significantly better than drugs already on the market. This higher threshold, although not explicit, would also be expected to slow drug approvals.

NB: How have recent scares like that of Merck & Co’s Vioxx, withdrawn after a link with heart attacks, impacted on approvals?

ASL: Vioxx triggered the cautious stance. There was also a very large example of a drug in development by Pfizer called Torcetrapib. That was terminated during development because fairly low levels of cardiovascular events were uncovered in that drug as well. $800m was spent on Torcetrapib’s development and it had been terminated.

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In terms of concerns over safety, it has meant that the FDA has been essentially very cautious in moving forward.

One of the new areas where there is tremendous opportunity, where the FDA appears to be moving very cautiously, is in the area of human trials involving stem cells. In that area they have been very slow to approve trials because of the lack of any data that validates a safe and efficacious approach.

So far I don’t think the FDA has approved any trials evaluating stem cells in humans.

NB: Recent figures show the pharmaceutical industry spent $168m lobbying congress in 2007, how successful were the industry’s efforts and what are the main administration issues concerning the industry at present?

ASL: One of the current major concerns is the potential for price controls, in part because new drugs tend to be quite expensive and, as a result, to some extent they can become unaffordable to the marketplace. There is an issue as to whether new drugs are going to be reimbursed.

There are also questions around whether the US may begin to consider price caps the way other countries have imposed price caps.

"One of the current major concerns is the potential for price controls."

Another issue of concern to the industry is potential regulation of direct-to-consumer advertising. To some extent it is a case of consumer education and that does occur but to a large extent there is some data that would suggest when advertising is removed, sales go down.

For example when Pfizer took all its advertising off after the Vioxx scare, the sales of their products went down. The visibility that is produced from direct-to-consumer advertising does seem to correlate with increased sales.

NB: What will the $275m boost proposed by the administration do to aid the FDA?

ASL: The FDA’s purview is quite a bit broader than just drug development. Some of that funding is going towards other efforts, including food safety.

The FDA is also looking at expanding its review of manufacturing facilities worldwide, specifically China in near term and India over the longer term. There are people who are going to be placed in those countries from the FDA in the next year or two.

There is also something of a brain drain going on within the FDA because many of the reviewers are old enough that they are beginning to retire in a significant numbers, so even with a new infusion of money and hiring, it will take a while for new reviewers to come up to speed.

NB: How are issues like the discussion around labelling laws being dealt with?

ASL: There has been a lot of debate around black box labelling (to warn drugs could have serious side effects) recently, including specific rules concerning epilepsy drugs. There is some interesting turmoil going on right now within the industry and within the FDA as to whether the black box label is the appropriate follow on action for all of these things.

Almost everything seems to be getting black box labels and in some cases it is the reiteration of what is already on the label, with obviously a stronger emphasis. There are changes going on within the approach to labelling but it is uncertain as to where that is actually going to go.

NB: What about issues such as reimportation?

ASL: Reimportation is a complex question because you are covering several international boundaries and laws.

There is, I guess, what one would call a black market for legitimate drugs that are being sold overseas that work their way back into the US because the differential in price is such that people can make money on it.

There was a recent ruling in Western Europe where pharmaceutical companies were trying to prevent the export of drugs out of the country. It was decided the practice was not illegal so it was left alone.

In that case the laws left in place a path for drugs to be reimported into the US through Canada.

"Some of the FDA funding is going towards other efforts, including food safety."

In the US the argument tends to be around the lack of the FDA’s ability to police drugs that are brought back into the country and therefore there is the potential for counterfeit drugs to enter the supply chain.

NB: Are the presidential elections likely to have any impact on the industry and if so how?

ASL: I don’t know how either candidate’s plans are going to shift current policies impacting the pharmaceutical industry, but both McCain and Obama will have an impact.

They are both talking about dealing with the uninsured population and reining in the costs of healthcare although neither one of them has outlined any specific policies that I think are completely averse to the industry.

I don’t think the industry likes any of the policies but it can tolerate them. There is nothing at this stage to say the industry is exclusively supporting one candidate or the other.