FDA’s Woodcock: ‘We Must Learn From Henry Ford’
13 CommentsBy Ed Silverman // March 26th, 2008 // 7:51 am
The head of the agency’s Center for Drug Evaluation and Research is responding to criticism as she embarks on her second stint in this position. Talking to The Financial Times, Janet Woodcock insists that science, not politics, is the reason fewer new drugs are reaching the market. When the FDA rejects a new med, the decision is based on safety and effectiveness, not political pressure.
“We have a different story from the companies. We understand that (they) have productivity issues but (we) stick to the same safe and effective criteria as our bedrock,” she tells the paper. “Pharma is having a difficult time but we are seeing drugs that have a lot of questions.”
Interestingly, her remarks appear just as The Wall Street Journal writes that several big new drugs that entered Europe in the past two years have hig regulatory roadblocks. The meds include Novartis’ Galvus diabetes pill, Glaxo’s Cervarix HPV vaccine and Sanofi’s Acomplia diet drug, which was just approved by the UK’s NICE. Novartis, however, may skip the US market after the FDA delayed approval and sought more safety tests.
“The scientists and physicians who are reviewing the products are looking over their shoulder at Capitol Hill,” Jim Shannon, the departing head of drug development at Novartis, tells the Journal. “I think it results in them taking decisions which are conservative.”
Woodcock conceded that the size and length of clinical trials had grown substantially in recent years, but argued that was a result of better understanding by regulators of how best to identify risks. “We’re smarter now (but still) humbled by what we don’t know.” She adds that the FDA will unveil proposals this fall to reduce drug development costs by standardizing the format and content of clinical trial data. “We need to learn from Henry Ford,” she opines. “Companies collect too much information because they are worried that the FDA will ask for it.”
She denied industry claims the FDA is turning down experimental drugs simply because they were more expensive or less cost effective than existing treatments. But “if there are choices out there and a new drug is less safe, we will not put it on the market unless there is some advantage.”
And she wrapped up her chat by lamenting the resources available for inspecting foreign manufacturing plants, which she described as thin. “We now rely on a risk-based approach,” she says in response to a question about Heparin. “Regulators share information but that does not totally compensate. There has been no increase (in inspectors) to the field.”
Dan
It’s possible Novartis, due to it’s rejection of it’s newer drugs like Galvus in the U.S., has galvinized the rest of us, possibly.
Matt
How about learning form the recent serious mistakes the FDA has made before moving off on a tangent?
AV Block
Obviously there has been an impact from politics. We’ve already seen a trend toward the introduction of innovative drugs outside the U.S. This trend certainly doesn’t help stem the trend away from the US as the center of innovation in biotechnology (as it pertains to therapeutics).
Justice in Michigan
Before moving to conclusions, we should read the Reuters piece that Ed links. Lots of dimensions here. UK is apparently alone in some of these decisions. And Accomplia was recommended against in FDA Advisory Committee as I understand it.
Ed Silverman
Hi Justice,
Yes, you’re correct. An FDA panel voted last June not to recommend Acomplia. However, the ‘regulatory roadblock’ euphemism can be seen to apply to the situation. On the other hand, I agree that is not the same thing as the agency itself declining to issue appproval.
Thanks
ed
Justice in Michigan
Absolutely. As you well know, much of the eighties was taken up by a highly politicized discussion of the “drug lag” which mostly didn’t exist, especially by the late 80s (and even before PDUFA). As I recall, Bruce Psaty testified in the Nov. 04 Senate Vioxx hearings that the majority (60%) of new drugs are first approved in the U.S..
AV Block
On the point of “drug lag” in the 1980s:
(1) I could have sworn I saw articles in the academic economics literature that examined delays in the drug approval process - presumably such empirical work looked at data in the 1980s. If I find, I will post the reference(s).
(2) I do think there was an acceleration in drug approvals in the 1990s thanks to advances in HIV therapies, among other things.
There are also plausible reasons why the FDA has little incentive to approve new drugs. Actually, I refer readers to http://www.fdareview.org/incentives.shtml. I’m quoting from this source, which I find very interesting, particularly on the discussion of hypothesis testing. Essentially, the FDA at this time does not want to commit a Type I Error - allowing a harmful drug, because “victims are identifiable and traceable, and might appear on Oprah.” The FDA does not have much of an incentive to reduce Type 2 Error - that is to say, “disallowing a beneficial drug. Victims are not identifiable and scarcely even acknowledged in the abstract.”
Lauren
Why didn’t she talk about drug lags as far as placing black box warnings or banning drugs altogether? Japan and the UK made Lilly place warnings in the Spring of 2002 on Zyprexa, as they had observed a realtively small but still significant number of people getting diabetes or dying from this lethal drug. My son was killed by it, due to profound hyperglycemia, in October 2002. We were obviously living in the wrong country as far as safety was concerned. Warnings were not required on Zyprexa until late 2003-2004. And the FDA didn’t differentiate out the worst, Zyprexa. Instead, by making all atypicals place this warning, a false picture was presented. All in the name of protecting their friends at Lilly. They continue with this behavior, having yet to require Medguides on the atypicals. For Zyprexa, that’s now twelve years of waiting for a medguide. Despite hearing this in testimony at their Medguide Meeting in June, 2007 by me, a mother whose son had been killed, nothing has been done about it.
Sorry not to pay attention to the approval end of things. I already know that Lilly hid Zyprexa’s lethal effects when going for approval in 1996 without ever having to pay any penalty for this behavior to the FDA. With any luck, they will really pay the piper in Connecticut, which has brought a RICO charge against them.
Bless The Truth
…”FDA does not want to commit a type 1 error….?? I don’t know about that. An organization willing to approve with “black box” even when it means the ignorant patients could die prematurely, has plenty of room to commit multiple type 1 errors and n-degree type II errors! To me, FDA is obsolete!
HorusCat
AV Block,
Great post. The FDA really has a thankless job. We recently had a doc come speak to us at a meeting about pain and the NSAIDs. He said that Novartis had recently had a new Cox-2 inhibitor shot down after investing more than $1 billion in it–the FDA just isn’t willing to move on anti-inflammatories, after the Vioxx debacle, even though the evidence is pretty clear that there was something unique to Vioxx that made it worse than the other NSAIDs in terms of cardiac outcomes. The interesting point the doc made was that this means we are probably at the end in terms of non-narcotic pain meds being developed. Celebrex, Aleve, Advil–they are probably all we are ever going to have, because companies aren’t willing to invest the R&D money in what seems to be a black hole with the FDA. Of course, we don’t know that a new Cox-2 would be any more effective than Celebrex, so we don’t necessarily need a new one. But we’ll never know, will we? I do think different NSAIDs work differently in different people–Celebrex does NOTHING for my pre-menstrual cramps, nor does Advil. Bextra, on the other hand, was like a miracle drug for them. So maybe we could benefit from more variety in the NSAID market. Doesn’t matter now, because it probably won’t happen.
Bob Freeman
AV Block, yes, there is a body of literature on the drug lag–I believe Hank Grabowski at Duke and perhaps the people at Tufts (DeMasi??) were the main contributors to the field.
One of the overlooked issues in drug approval is the delay in launch of a newly approved drug due to the lenghty process to get reimbursement approved in some European countries. So, there are 2 key dates: date of approval and date of launch. It is relatively easy to get approval through the EMEA, but reimbursement and pricing remain national perogatives.
Japan is usually the last major country for approval and launch because of their requirements to repeat clinical trials on ethnic Japanese subjects and their societal concern for drug safety.
Grieving
As to Bob Freeman’s comment that Japan is usually the last country to approve a drug due to their “societal concern for drug safety”: Japan was the first country to require a warning on Zyprexa. They obviously take drug safety seriously. It would be interesting to count up the number of people killed per number on the drug Zyprexa there versus here. Or any other drug for that matter. I admire a country that takes drug safety seriously as opposed to the U.S., who view it as cost-benefit ratio.
Bob Freeman
Grieving, You raise an interesting question about comparing suicide rates, a very interesting one indeed. From my own experience one often sees what we occidentials would consider to be a sub-therapeutic dose of a specific drug or drug class in the approved labeling in Japan. Ostensibly, it’s to reflect the smaller physical sizes of ethnic Japanese; the alternative view is that they want safety first, efficacy second (a gross oversimplification on my part, but applicable.