FDA’s Andy von Eschenbach: In His Own Words
17 CommentsBy Ed Silverman // February 27th, 2008 // 9:22 am
Under fire from all quarters - pharma execs, politicians, consumer advocates, patient groups and investors - Andy is now trying to deflect the criticism in a strategic interview with The Wall Street Journal. The silver-haired, lasso-tongued physician (who talks about ‘deliverables and measureables’) and Bush family friend may realize his job is more daunting than expected. Whether this charm offensive will have an impact, though, remains to be seen. Here is an excerpt…
On the FDA’s budget needs:
I have not intended to create the perception that I do not believe that the agency needs more resources. Just the opposite. I’ve been very direct and very open in the fact that when I first arrived two years ago, one of the first things that I recognized that needed to be done was to create the business plan, so to speak, that would justify and be able to define what those additional new resources were that were going to be required…It would be short-sighted for us at this point in time to simply view the solution of this problem being we should throw more money at the FDA. Double its budget….It may actually require more than that. It could conceivably be done for less than that…
Our thought: But wait, Andy, you did ask for more money - so which is it?
On the need for FDA oversight overseas:
…FDA beyond our borders is a strategy, is an initiative, and FDA beyond our borders will over the course of the next few years require resources in order to implement…To accelerate FDA beyond our borders, to expand the number of sites around the world where we will create FDA offices, is obviously resource intensive. And if Congress chooses to deem that to be an important and appropriate authority and to invest and commit more resources, we have a plan to be able to spend those effectively and wisely.
Our thought: So, Andy, you do want more money, at least for certain things, right?
On the FDA’s drug-safety effort:
We’ve done a good job on the front end of being able to create a systematic way of dealing with that data and that information and processing it with time lines and deliverables and measurables…in the preapproval process. We need to make sure we’re doing the same thing with how we process safety signals. So that we are looking at that in a regimented, disciplined kind of way, and we’re bringing the right expertise together to address that signal. So for example, creating a multidisciplinary integrated team that looks at expertise that can involve geneticists, can involve epidemiologists.
Our thought: With all due respect, Andy, this has been a problem for a decade and so this should have been a top priority to be addressed from your first day in office.
On balancing the responsibilities of the FDA’s drug-safety office and the divisions that review drugs before they go on the market:
I think those things have to be done in a way that compartmentalizes it and eliminates bias. I’m not prepared to tell you right now today who’s going to be at the table to make those decisions. But I think what you’re driving toward is the need to make these decisions in an objective, rational systematic kind of way that’s open and transparent and that’s based on science and scientific analysis of the data.
Our thought: Please, Andy. You say want to be open and transparent, but you still won’t discuss the kinds of people who will participate?
On the FDA’s need to change:
The fact of the matter is we seem to be wanting to make the case that the FDA somehow is broken or has failed. It hasn’t failed. But what we really need to be talking about is the fact that it needs to change. Because it needs to keep pace with the changes that are occurring if we’re going to continue to be able to say that tomorrow. This agency is the world’s gold standard. And people, you and I, will go home tonight and we will have dinner and we will not have to worry about having that dinner. I will give my grandchildren the medication they need when they are sick, and I have confidence and trust in those medications. But that doesn’t mean that I’m not looking at tomorrow and realizing that if we don’t make the kind of changes that are necessary today, we’re not going to be able to continue to assure that tomorrow.
Our thought: Nice speech. But if there wasn’t a string of failures, you wouldn’t be saying this today.
Our favorite quote: “FDA must speak to the American people, every single person, because it’s your health that is our mission.”
Matthew Arnold
“Lasso-tongued?” I like it. Nice one, Ed.
John Mack
And OUR mission is to get rid of Andy and all the other Bush cronies along with the rest of the all-talk, do-nothing Republican rabble! Hopefully, we won’t have to wait long.
WBP
Andy is simply another Bush buddy who was appointed to a post because he is a cronnie and has failed miserably in his job. FDA is just like EMA. Hell of a job Andy!
FDA’s Andy von Eschenbach: In His Own Words
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AV Block
It is amazing. With all this attention on safety, drug companies will just market new drugs overseas if the FDA continues to remain overly cautious on safety. If you want safety, you’ll just have to clamp down on innovation. Rich people can gain access to new drugs by flying overseas and paying out of pocket.
Drug safety is a distraction. In addition to the deleterious impact on innovation, the public has not been attuned to the gradual erosion of intellectual property rights, seen in the rise of paragraph IV filings from Indian and other non-US pharmaceutical companies. Let’s just outsource the pharmaceutical manufacturing industry overseas (sarcasm noted)!
Insider
http://pharmagossip.blogspot.com/2008/02/andys-team.html
Justice in Michigan
Who’s on first?
I’d say it’s clear Andy wants to double the budget, or halve it, depending on what it looks like at the time.
As for drug safety and innovation, the so-called “drug lag” is mythology. See Howard Brody, _Hooked_, along with many other sources. Even before PDUFA, the rate of approval in U.S. was essentially the same as UK. Bruce Psaty noted in the Nov ‘04 Senate hearings that 60% of new drugs are first approved in the U.S..
Re: drug safety in general, I could not disagree more that it is a non-issue. Just this addendum to Ed’s post - an independent ODS has been proposed by reviews of the FDA since the 1970s, including a couple of studies by the National Academy of Sciences. So more than a decade - a generation!
Nathan
Justice,
While I don’t fully support AV Block’s statement, I believe that his overall assertion is correct: Safety and innovation work against one another. There are so many unknowns in drug-development that a truly safe drug is just not possible. Most people don’t grasp the concept that many of the safety issues that have plagued recent drugs occur with such infrequency that it just isn’t possible to pick up on these adverse events until after the drug is marketed. Usually the drug is marketed based on studies in a few thousand people (max). If a rare (but deadly) side effect occurs 0.1% of the time, you are talking about only 2-3 events maximum observed during the clinical trials. Determining whether this is statistically significant is nearly impossible. The drug gets approved and goes to market. Now you have hundreds of thousands of people taking the drug. Hundreds now have this deadly side effect. Who gets blamed? The FDA and the pharmaceutical companies. In reality, who is to blame? NO ONE.
The legislative (or judicial) pursuit of risk free drugs will result in the death of pharmaceutical innovation. Period.
Andy’s team! | Biotech Stocks Blog
[...] Ed dissects the Commish! [...]
Laurie
“Most people don’t grasp the concept that many of the safety issues that have plagued recent drugs occur with such infrequency that it just isn’t possible to pick up on these adverse events until after the drug is marketed.”
I would buy that if we didn’t have new information coming out daily on the misrepresentation of initial clinical trial data. That is where the mistrust is coming from. Pharma can’t continue to claim “we didn’t know about the problem until it went market wide” when the data disputes that claim.
Yes, drugs have side effects and alot don’t become an issue until they are given to “real, unscreened” patients. But the fact that we are seeing that the problems were there and undiclosed is a BIG problem.
truthman
Laurie
“Most people don’t grasp the concept that many of the safety issues that have plagued recent drugs occur with such infrequency that it just isn’t possible to pick up on these adverse events until after the drug is marketed.”
I agree with Laurie , I don’t buy it either Nathan…
If this was the case then why do situations like this happen?..
http://seroxatsecrets.wordpress.com/2008/02/26/glaxosmithkline-the-game-is-up/
Justice in Michigan
Nathan - To say it again, my questions are versions of the Watergate ones: (1) What did they know? (2) When did they know it? (3) What did they do?
I also recognize there are often (usually?) ambiguities surrounding getting clear answers to any of them. But, while the quesitons may be difficult to answer, they are not impossible.
I believe there are cases in which is is clear companies _did_ know (post-marketing), covered and camflaged, and went out of their way to continue to do so. There are also many cases when they did not. The former are the situations that I think about when I think about “drug safety.”
Jaynesday
Mr. Eshenbach insists that the FDA is not broken. Here is the table of contents from the FDA Science Board Advisory Committee Meeting. A report made to the FDA about the FDA. You can find the complete report on the FDA’s internet site. Read through this and when you are done let me know if you still feel that the FDA is not broken. Explain to me how -can not fullfill it’s mission- doesn’t mean that the organization is not broken? Remember to take you head out of the sand as it is very hard to hear you.
FDA Science Board Advisory Committee Meeting
Table of Contents – (Edited to show only the statements on the conditions of the FDA)
Major Findings………..3
1.2.1 The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak………3
1.2.2 The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability………….4
1.2.3 The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate…………………………..5
2.1 Growing Disparity between Responsibilities and Resources…..9
3.1 Science: Capability, Capacity and Organization….20
3.1.1 Finding: FDA does not have the capacity to ensure the safety of food for the nation…21
3.1.2 Finding: The development of medical products based on “new science” cannot be adequately regulated by the FDA….24
3.1.3 Finding: There is insufficient capacity in modeling, risk assessment and analysis….30
3.1.4 Finding: The FDA science agenda lacks a coherent structure and vision, as well as effective coordination and prioritization…….33
3.2 Workforce: Securing Critical Scientific Capability and Capacity38
3.2.1 Finding: The FDA has substantial recruitment and retention challenges…..40
3.2.2 Finding: The FDA has an inadequate and ineffective program for scientist performance…….42
3.2.3 Finding: The FDA has inadequate funding for professional development……….42
3.2.4 Finding: The FDA has not taken sufficient advantage of external and internal collaborations……….43
3.3 Information Infrastructure……..45
3.3.1 Finding: The Subcommittee believes that there is evidence of important, but slow, progress to improve information sciences and technology at the FDA over the past few years, yet significant gaps remain……46
3.3.2 Finding: The FDA lacks the information science capability and information infrastructure to fulfill its regulatory mandate…………47
3.3.3 Finding: The FDA cannot provide the information infrastructure support to regulate products based on new science…….49
3.3.4 Finding: The FDA IT infrastructure is obsolete, unstable, and lacks sufficient controls to ensure continuity of operations or to provide effective disaster recovery services……50
3.3.5 Finding: The IT workforce is insufficient and suboptimally organized……..51
Melody
An excerpt from a Gooznews’ article
http://www.gooznews.com/archives/000975.html
states: “a treatment registry to track clinical outcomes for patients with difficult to treat diseases. . .would bring the doctor and patient back into the knowledge acquisition process … something very threatening to the narrow interests of drug companies . . .and their sponsored physician experts/Key Opinion Leaders who shape clinical practice and clinical research.
This is an alternative to the current adverse events reporting system which, to my mind, is one of the critical areas at FDA that is dysfunctional. Clinical trials–generally designed by drug manufacturers to prove efficacy–should not be the only metric for drug approval. A clinical registry where MDs could quickly note adverse events–and without FDA’s voluminous requirements for follow-up–would permit safety issues to be addressed in a TIMELY manner. Instead, the current FDA system seems to rely on the accumulation of ‘dead bodies’–when the pile of dead bodies is high enough, alarms sound and investigations proceed. (Not much help for those in the pile!)
Getting rid of cronyism, and seeking out experts to run the agency who place mission above politics would be a start for repairing this current sad excuse for an agency tasked with protecting the public. There ARE smart, talented, creative experts ‘out there’ . . . hopefully a new administration will ferret them out and start to repair this damaged agency.
Jaynesday
To AV Bock and Nathan,
Your logic is appauling. If all industry took your approach to new product development - Safety just gets in the way of innovation - -Safety and innovation work against one another - where would we be as a society?
Safety must be the major part of product development! For example: We could easily design a car that would get 150mpg if we made the body panels out of paper. Would you drive one?
So let’s drop the pesky requirements for safety and emphasize the requirement for buyer be ware. What wonderful innovation we will see.
Personally I hope and pray that any drug/device company that feels the way you do does move offshore and/or goes out of business. The sooner the better.
Justice in Michigan
I think what we need is reliable (unspun) data in which it could be shown that regulation has had any impact whatsoever on innovation.
In general, the industry could not exist without regulation - patent protection, PDUFA clock, FDA “seal of approval,” and on and on.
I would suggest that it is more likely, after objectively crunching numbers, that safety surveillance - inside and outside companies - has _added_ to innovation.
I would also suggest smart companies know that.
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