FDA Rule Shields Pharma From Lawsuits?
54 CommentsBy Ed Silverman // August 22nd, 2008 // 10:26 am
The rule, which would limit changes that can be made to product warnings was posted on the FDA web site and is likely to protect drug and device makers when they have “knowledge of potentially hazardous side effects,” Gerie Voss, director of regulatory affairs for the American Association for Justice, tells Bloomberg News.
Eight Democrats from the House and Senate objected in January after the FDA published a proposed version of the rule. The lawmakers wrote in a letter that the measure sets a higher standard for when companies can make changes to package inserts alerting consumers to new safety information without waiting for FDA approval. And the effect would be to protect companies from being sued for failing to disclose risks.
“The final rule is going to give drug and device companies the ability to claim complete immunity for failing to warn about potentially hazardous side effects of prescription drugs and medical devices,” Voss tells Bloomberg. Here is the new rule.
The rule clarifies an FDA policy that has long been in place, said Randall Lutter, the agency’s deputy commissioner for policy, tells Bloomberg, by allowing drug and device makers to add information to product labels before an FDA review is complete in certain circumstances. “This action should reduce confusion about what our policy is, clarify it and provide additional confidence to patients and doctors that information on medical product labels has a sensible scientific basis,” he says.
The PhRMA trade group supports the FDA rule. Doctors and patients “look to the FDA - widely considered the world’s gold standard - to provide them with balanced information,” according to a statement from senior vp Ken Johnson.
Justice in Michigan
If anyone wants to know what a coup looks like in slow motion, you are watching it here.
The changed rule has been discussed a few times here. Effectively, it allows companies to delay releasing important safety information by saying, “Well, we had to get FDA to say so first.” As we know that can mean months of deliberation, obfuscation, etc., while who knows what happens.
As also discussed, there has been perhaps one case in which FDA actually asked a company to take back a warning that they had added (and FDA blessed a few weeks later). So any argument that this prevents “dangerous overwarning” is the usual self-interested horse manure.
Pharma is adding a nail to its coffin (and ours) with all of these ploys. Each one of them “overwarns” about the wisdom of trusting the industry, and its products, at all. There will be hell to pay - for them which means for all of us.
Justice in Michigan
Just reviewed (again) the old and new rules. The old rule was that the following could be added by company (still subject to FDA review):
“a warning
about a clinically significant hazard as soon as there is reasonable evidence of a causal
association with a drug”, even though a causal relationship “need not have been definitely
established.” (9 201.57(~)(6)(e
Association, but not definitive causality, is the criterion.
The new rule insists on “sufficient evidence of a causal relationship” (quoting from memory), so the bar is significantly raised.
It is also written with a kind of obsessive casuistry which almost says, by style alone, that “We know we pulling a fast one, but maybe you’ll be taken in by it.”
Don’t be taken in. This is as scuzzy as it gets (except when it gets scuzzier).
harpy
Agreed, Justice, it stinks. I keep reading the headline over and over, trying to make it make sense. FDA issues rule to shield Pharma from lawsuits. Isn’t FDA supposed to protect us? This is worse than the fox guarding the henhouse - this is the farmer telling the hens they better do what the fox says.
Every day I see more evidence that my government hates me. Not only do they want to kick me when I’m down, they expect me to thank them for sullying their boot.
atlex
Ed,
I’m disappointed in your headline since only a mindreader could say with certainty what the FDA’s intent was beyond what its statement said. It looks as though you accepted the trial lawyers’ (AAJ) opinion as gospel despite the fact that they have a clear (and quite profitable) COI. I’m not saying that the end result won’t be increased protection for pharma companies or whether that is a good or bad thing. I’m simple stating that the headline seemingly turns conflicted speculation into fact.
Atlex
Justice in Michigan
Harpy - It’s even worse. It’s the fox ordering out, “I’ll have two henhouses with pepperoni.” And the FDA delivers it to the den (in thirty minutes or less).
Atlex - I think you are being disingenuous. No one who has followed the preemption saga - as I know you have - could have any doubt about what the intent is of _this_ FDA, and its Office of Chief Counsel specifically.
It has defended its position on preemption many times, in briefs and otherwise. Its current and former counsels have spoken out speicifically against the older CBE rules as opening the door to “Trial Lawyers, Inc.” Ed’s headline only says what we know and is on the record.
This FDA favors preemption. Which means (and can only mean) this FDA intends to shield pharma, in compliance with FDA, from lawsuits. As the folks on DDL will tell you, the CBE rules were large chink in the preemption shield. FDA now tries to close that shield.
It doesn’t take a mind-reader. See who wrote this stuff. Same old gang preemption gang.
Former pharma Marketing Exec
This is of course exactly as JIM say’s it is.
This completely undermines the rights of patients and significantly interferes with the patients ability to obtain all the known facts - informed consent. In effect it is taking several rights away in one fell swoop.
If something like this were to actually be passed into law then citizens of the United States of America should immediately have access to universally funded health care and they should no longer pay one cent out of their pockets for any essential drugs or medical devices.
We are all consumers in the health care “game”. As such consumer’s rights cannot be bargained away away like this.
What has Pharma “promised” government for this?
I am thinking there was a ship full of tea in a harbour…John Hancock imported tea from the Netherlands in order to not have to pay the tax to the British. The Tea Tax the British had levied in order to “preempt” any American colonist from selling their goods to their own citizens….
“Many American colonists, particularly the wealthy smugglers, resented this favored treatment of a major company, which employed lobbyists and wielded great influence in Parliament. Protests resulted in both Philadelphia and New York, but it was those in Boston that made their mark in history.”
All this time we have been overseas fighting wars to protect our rights when our government just swipes them away from us right here on our own soil….
This is a sham and a shame….
Justice in Michigan
Re: the title of the thread, I am just noticing now that Ed puts a question mark at its end. So it is precisely the opposite of accepting anything “as gospel.”
James R
Maybe the FAA can come to the aid of airline companies also. The FAA can change the rules, let an unsafe airplane fly, let it crash and then let the airline off the hook.
atlex
JiM,
I could be wrong, but I think the question mark was added after my posting. I don’t remember seeing it prior to that. If I did miss it, I certainly apologize to Ed.
Atlex
Ima Misfit
Words that could only come from the mouth of a PhRMA lobbyist:
Doctors and patients “look to the FDA - widely considered the world’s gold standard - to provide them with balanced information.”
If the FDA is the “gold standard”, would someone please pass me a bottle of cyanide laced Tylenol.
Jaynesday
Per Randall Lutter -
“This action should reduce confusion about what our policy is, clarify it and provide additional confidence to patients and doctors that information on medical product labels has a sensible scientific basis,”.
So I take it that the product manufacturer’s concern about their own product’s safety issue is not enough for the FDA to allow a warning? In other words they don’t trust the manufacturer to warn their customers - and this is suppose to make us feel more confident?
The statement is that they might not be capable of making a sensible decision about the safety of their own product.
What about when they designed, tested and marketed the product?
I’m not sure what kind of fools these people take us for but they are clearly out of touch. I still like the question - What color is the sky in your universe? I suppose its at least alway sunny there when you live high above the clouds of foolish mortals.
My uninformed mind feels this is a backup plan in case of the failure of preemption.
Hey if I’m way off base please let me know. It might be me that’s delusional.
Justice in Michigan
Atlex - Well, we both missed it, so perhaps it is, indeed, a “living document.”
In any event, since we so often return to the COI argument, maybe a few things worth considering.
A lot of the argumentation - in places, the exact language - that is used to justify the rule change comes directly from Dan Troy. Not surprising - he was FDA Chief Counsel until late ‘04, and all of this was in the works - the preamble, CBE change, etc. - which work together toward preemption.
So, is this “the voice of FDA”? It is the voice of FDA at a particular historical and political moment. DT, as you know, represented big tobacco and big pharma as primary clients before coming FDA Chief Counsel. Recently, he has become Chief Counsel and #2 at Glaxo. Should we imagine that, duing his tenure at FDA, his convictions about industry interest dried up and blew away?
I am not suggesting impropriety - just the fact of a highly politicized, even ideologized, FDA - comparable to a few of its iterations in the past, but probably never approaching the current scale.
So, with or without the question mark, I think it is accurate to say that the rule change will, indeed, serve to shield pharma from lawsuits and, indeed, that is centrally its intent given who drafted it and when and FDA management’s championing of preemption in general. Mike Leavitt’s commentary on the preemption preamble, for example, is explicit on the “problem of lawsuit abuse.” (How else would you justify preemption?)
Yes, I understand that FDA would like to highlight the notion that all it is doing is tightening up existing regulations. But to anyone who knows anything about this, that is like saying the reason Saddam was hung was to gete some kinks out of the rope.
Justice in Michigan
Jaynesday - Not a back up plan so much as part of the overall strategy. The older rule left a way for plaintiff’s to argue that companies could, and should, have issued warnings when they became aware of a potential problem. This was a critical hole in the preemption defense.
The purpose of this law change is to plug it.
Chris
This law takes effect in Sept 2008. I would expect pharma companies can still be held accountable for behaviors prior to this.
Justice in Michigan
Interesting point, Chris. Not a lawyer, so this is just a guess. I believe the change is under the category of a “rule,” not a law - in the sense that nothing was passed in any legislature; rather FDA is saying it is clarifying its own regulations, which it has the power to do.
Whether that has the force of law will depend more, I’m guessing, on what judges decide. In the decisions concerning the preemption preamble, for example, some judges have relied on it in cases that concern incidents before it came out - saying that FDA’s revised policy is still worth deference. Other judges - I think still the majority - have ruled differently. As I recall, good old Judge Higbee blew it off as “a purely political document.”
So my guess would be that this will be in the same category.
BP Watch
This type of action is exactly why Obama will be elected. It’s the rich and powerful taking care of other rich and powerful, while screwing the American public!
Jaynesday
BP Watch,
I don’t agree with this rule, and would never vote for Obama.
Politically speaking (and I hate to muck things up by doing so) the Republicans seem to be taking a page out of the Democratic hand book by imposing govermental controls on the American public and in doing so damaging the effective process of self regulation.
Justice in Michigan
Hmmm. Well, I don’t want to get messed up in partisan stuff. The “good news” is that both major candidates have entirely avoided the preemption issue. That is reason for every one of us, and wherever we otherwise stand, to get on their tails about it.
Jaynesday makes the interesting point that, in many ways, FDA preemption is a violation of traditional Reublican principles - not giving irrational powers to the feds, supporting states rights and autonomy, supporting what is organic and diverse in communities rather than imposing some top-down “social planning.” Here in Michigan, a number of those most opposed to our preemption law are libertarian conservatives.
What is also interesting is that the current Supreme Court - both the alleged conservative and liberal members - seem oriented toward this reversal of traditional federalism in favor of special (viz, corporate) interests.
So this may be an issue in which traditional “left” and “right” positions are meaningless. And we return, instead, to core issues of reason, justice, and civil liberties.
Those are good places to be.
Kettle to Pot
JiM,
I don’t think that the current administration is being disingenuous in this instance. It doesn’t believe in more federal power; however, where federal regulations are in place, it consistently believes that the corporations subject to these regulations should be protected when following them. Similarly, I don’t at all believe that business friendly regulation at the FDA or any other federal agency is about some quid pro quo. The administration simply has a very pro-business position and is active in supporting its position.
Atlex
Jaynesday
Kettle to Pot -
I am all for the pro business position to a certain extent. But when being pro business means turning a blind eye to the consumer, I draw the line.
The Supreme Court and the FDA seem to be advancing toward a state in drug and device safety that says in effect -
The consumer doesn’t need to know, should stay out of, is unwelcome in the process of insuring the safety of the drugs and devices he/she puts in their own bodies. The consumer should just be quiet and assume that we (The FDA, Supreme Court, Republican party)will take good care of them. I feel that this is the blind they are pulling over our eyes. The blind that’s real purpose is to free pharmaceuticals from risk as they furiously invent the next blockbuster drug.
Justice in Michigan
KTP/Atlex - I’m not sure my position is different from yours. Yes, it’s a “pro-business” agenda. But, as Jaynesday beautifully says it, it is pro some businesses and not others and, rather than the marketplace and other traditional Republican/conservative views of business, it s using federal regulation and other federal powers specifically to _protect_ those businesses from the market.
Back in the 90s, before they captured FDA, most of the same people behind preemption advocated we dismantle the FDA entirely. This was a serious proposal - Gingrich led the charge, demonizing Kessler (a Republican appointee) - and it came within a vote or too of happening. This would have taken us back to the pre-thalidomide FDA, privatizing everything, and dissolving what we have come to know as required trials for safety and efficacy as well as informed consent for pts in trials.
That would have been, to me, a horror show, but it was in the spirit of minimal govt regulation. Some of its proponentns said, out loud, that “a few thalidomides” were worth all the good things that the free market would yield.
But these are legitimate policy debates (even if I hope it’s their baby, not mine). In the meantime, mass-marketing “blockbusters” as Jaynesday describes, and doing so in what the industry itself calls “the evidence-free zone,” is not my idea of the reponsibile citizenship that also goes with business.
In a strange way, I think many of us have become more cynical about business than those who pursue it. That is because of the privileges and abuses that can be attributed to some businesses in particular.
Justice in Michigan
p.s. If this wasn’t clear, I wasn’t suggesting a quid pro quo related to DT, but there certainly was related to Gingrich. He essentially told pharma that, if they wanted his folks to do what they were doing in Congress, there should be campaign money coming in. That was the beginning of the 80/20 Rep/Dem campaign contributions from pharma that has stayed pretty steady until a couple of years ago (when Dems took Congress).
Again, it seems to me disingenuous to say that the current administration “consistently believes that the corporations subject to these regulations should be protected when following them.”
The members of this administration and its appointees _fought_ those regulations - and successfully - until they were cut down to the appropriate size (in their view) once the relevant agencies were captured. Once slimmed down, they could be canonized. And (in this case) the FDA’s own views about its own regulations, and what they did and did not preempt, were turned on their head.
If one honestly believes that canonizing this FDA will create the optimal balance of regulation, economic liberty, and accountability, that is a genuine discussion to have. But there you have to get into particulars - the way FDA and industry actually work - and get beyond rhetoric and smoke.
Just A Thought
Concerning this being a partisan issue and whether Obama is less pro-pharma than McCain:
I’m not so sure that’s a fair assesment. This is not a partisan issue but that of human safety and legal rights for all citizens. Some people did get more pharma contributions than others when they were in the early stages of running for their party’s nomination (can’t find that list now, sorry). The debates were going on just as this issue had recently become the most important for me and I was watching debates of both sides.
Curious what Obama has to say about it. I have heard nothing from the democrat’s side of the fence but would sure like to.
This is a clip of a debate where McCain & Romney touched on pharma (not nearly enough but it’s something).
http://www.youtube.com/watch?v=XB-cvcCeAqs
Justice in Michigan
JAT writes: “This is not a partisan issue but that of human safety and legal rights for all citizens. ”
That’s what I said, so I assume this was not to me - I have been waiting for both candidates to take clearer stands on all the relevant issues - preemption and beyond - that we discuss here. There’s been essentially squat. Beyond the Congressfolk who were part of the Levine brief, that is also true of Congressional candidates.
Whatever side people are on, I hope they will push these issues into the public debate.
Jaynesday
JaT I agree with you. Partisanship usually sinks the ship.
Atlex
JiM,
The quid pro quo comment wasn’t directed at you. Others keep suggesting that the FDA is responding to dollars being spent by the industry. In reality, it’s not about the dollars, it’s about similar philosophy.
By the way…for JaT, I believe that pharma dollars directed toward Obama are double or triple of those received by McCain.
Atlex
Justice in Michigan
Atlex - Agree that industry, administration and _senior_ FDA management (especially Office of Chief Counsel) are currently “in alignment,” ideologically speaking. I happen to have contact with others at FDA who view preemption as madness, given what they know - from direct experience - about what compliance means in practice.
You may recall that even Sandra Kweder - a senior FDA person - when asked about preemption at the Nov. ‘04 Senate Finance Committee hearings re: Vioxx - agreed that FDA approval should not preempt civil liability. I assume she was “taken out to the woodshed” and “reeducated” after that spontaneous expression of opinion. As far as I know, we have not heard from Sandra Kweder on this issue since.
Re: pharma contributions, they now go back to the older pattern - where the wind blows.
Do I believe this reflects either principle or ideological conviction? No, I do not.
Former pharma Marketing Exec
Good thoughts here all!
I was wondering if every citizen in the US needed to get themselves incorporated in order to get their rights back and voice heard.
Wasn’t the declaration of the US started with ” We the People….” Not, “We the corporate/Industry representatives of the people of the US”
So, the idea that this is a “pro business administration working” doesn’t fly with me and shouldn’t fly with too many others.
The question is what are the American people getting in return for their loss of rights on these issues?
JIM, if the candidates are acting like puppets because of Pharma funding, that it is hard for me to discern what exactly their own principles,ideological convictions are. Maybe they should just walk their own talk and stop leaving us all guessing….
Justice in Michigan
Former - I dont’ see the issue as “puppets” in the service of campaign donations. Rather, I believe the candidates (especially Obama) are afraid to be tarred with the “shill for trial lawyers” brush that we have seen deployed here on numerous occasions. Because of the kind of obsessive rage that people put into that issue (not unlike what we see on the other side coming back at “big bad pharma”) it is not easy to be clear about meaning. So my sense is that, on the O side, this is viewed as more trouble, and more risky, than it is worth.
O’s position on civil liability and regulation is also a complex one. I am assuming he and his staff also feel it is not the kind of thing that lends itself to “sound bites.”
Based on the past - although I’d love to be wrong - my guess is that McCain would side solidly with preemption advocates, even though - as I’ve emphasized - this need not be a partisan issue. Indeed, in the Youtube bit that JAT links, you can see McCain’s contempt when Romney tries to deny the malfeasance that really does go on. McCain comes very close to - indeed, actually does –talk about “big bad pharma” himself.
Still, I doubt very much this will happen in the elecion. Again, not because of donations directly, but because of the wider “base” as represented in the Chamber of Commerice, etc., which is (actually) the most powerful lobby of all. McCain taking on pharma - if you’ll excuse a bit of 60s language - would just freak ‘em out.
Former pharma Marketing Exec
JIM, it still comes down to the fact that if they are taking Pharma money to fund their campaigns, there isn’t necessarily any strings attached. Pharma as any other business need to get a good ROI on their money. The candidates know it, especially if they do not take on these “tough” issues.
Although I’ve never done it before, I have a feeling that when November comes around, I will be writing in a Candidate name. I think many more of us should do it. Wouldn’t it be very “cool” if we actually got someone drafted as the president of the US that wasn’t backed and “managed” by corporate America?
” And the Times they are a changing…”
Atlex
Former,
Now you’ve just proven that you’re delusional…a write in candidate. LOL!!!!
Just to be clear, I think any lobbyist will tell you, money rarely changes minds. But it does do a few other things…it provides candidates who agree with your position more resources for elections; it creates more access for the giver, etc. By the way, most pharma PACs don’t provide money for federal elections. The pharma money from the phjarma industry that goes to McCain and Obama is predominantly from individuals.
Atlex
Dan A.
The collusion between the FDA and the pharmaceutical industry has manifested from being a tacit relationship to a clearly overt one.
Former pharma Marketing Exec
Altex,
You are always quick with personal insults and never have your facts straight. All the more reason that I realize that you are an amateur with a very long road ahead of you!
However, your statement “The pharma money from the phjarma industry that goes to McCain and Obama is predominantly from individuals”. Yes, it is from individuals - it is from the individual patients that have paid for the drugs ;-)
I am not sure anyone can say that money does or does not make a person change their mind, however, I think we all agree that it can “motivate” you do something that probably wasn’t on your mind. Not sure if it eventually becomes “epigenetic”.
Justice in Michigan
Without getting into weighing one factor over another, I think lobbyists can be thought of as “sales reps on steroids.” On the one hand, gift “goodies” are sometimes useful. But the key is to have “entry” and relationship. “Face time” and “the ear.”
Of course, that is why the revolving door revolves. It is moving people around who already have “entry,” and so there is no need to start from scratch, or even from cake.
Anyway, many permutations, as with sales reps, so probably most useful to see the relationship as a whole package, with certain features more prominent in certain cirumstances.
atlex
Former,
My comment was not meant as a personal insult. I was responding to your statement about drafting a 3rd party candidate as President. I know you were being aspirational, even though everyone knows the impossibility of it. I was trying to playfully comment that if you really believed that it could happen, you must be delusional. I intentionally used the LOL to indicate that I was joking.
And, by the way, the only insult I’ve hurled your way has been associated with you continuing to try to pass yourself off as some high level pharma industry insider who has more knowledge of the inside workings of the industry than those of us who are actually in the industry today.
As for your most recent statement, I think you are wrong and stick by my comment that money rarely changes minds.
Atlex
Former pharma Marketing Exec
Altex,
I am still in the industry - don’t be fooled by the “Former” in my moniker…
That makes two of us - I stand by what I have said..;-)
truthman30
The day will surely come after this law is passed when an employee of the FDA or Big Pharma loses a family member to a defective drug or medical device… But by then it will be to late to shield and protect the public ..
Very sad and depressing ..
atlex
Former,
What do you do in the industry–not specifics, but in broad terms? We know HC is in sales; we know that Nathan and I work in major pharma–he in science and me in an HQ support function. What do you do?
Atlex
Nathan
FPME,
You previously said that you were NOT in the industry — and you have repeatedly said that you were glad to have left this industry after 18 years in it. What’s your story? Did you get re-hired into a pharma company?
I’m guessing you got downsized and forced to work for a government agency or public policy agency of sorts. In spite of your haughty “know-it-all” attitude, you certainly don’t seem to have a good familiarity of pharma R&D.
Justice in Michigan
T’man - that day has actually come. Particularly in the arena of medical devices, there are famous cases in which major “tort reform” advocates and campaign contributors were themselves implanted with a malfunctioning device which nearly killed them. They said, in effect, I’m for tort reform, but “this is crazy.”
In pharma, Colacicco of the famous Colacicco case had also been an activist supporter of tort reform. Those attitudes have changed with regard to preemption.
These are not people in pharma, but certainly people who had been strongly pro-preemption before it happened to them. I do know people in the industry who have had rougly similar experiencez, but I cannot go into more particulars.
Jack2
Former: This completely undermines the rights of patients and significantly interferes with the patients ability to obtain all the known facts - informed consent. In effect it is taking several rights away in one fell swoop.
With or without this change the PI is/was/and never will be the whole story. It’s a shortened summary that in theory is readable.
The two best technical arguments for preemption:
1. Spontaneous AEs: Spontaneous AEs are reported to the company and the FDA. A company forwards the reports to the FDA. Only the FDA gets all of the AEs*.
2. Class Effects: Many (most?) warnings are class effects. Some of these safety liablities can be discovered when an individual product is tested in a new patient population. Even if only one product within a class is tested in this population, sometimes all products in that class get that warning. However, if an individual company makes a product in that class, but did not specifically test their product in that population, they will not know about the safety hazard.
…Again I reserve my overall judgement. I really have no idea what % of lawsuits against pharma fall under the “explotative” label, and how much pharma spends defending itself from those suits. Without that number I can’t form an opinion. I just want to highlight two relevant facts.
*The database will change and become more open. I don’t know exactly how far it will go, but that change could affect how complete a picture that pharma could get of spontaneously reported AEs.
Justice in Michigan
Jack2 - As always, I appreciate your perspective. And I also appreciate your taking me up on calling such lawsuits “exploitative” rather than “frivolous.” That should help all of us think through what we’re really talking about, and how serious an issue it is. (It is too easy to “frivolously” - and irresponsibly - talk about “frivolous lawsuits”!)
I am less clear about what you are arguing in the rest of your post. The amended CBE rules concern data that is _not_ necessarily reported to FDA, at least not in a relevantly timely way. The original law was there so that companies could (and, presumably, should) get the word out about immediate risks arising in “real time” and_without_ having to wait for full FDA review. Clearly, this was intended (rightfully) to be limited to to serious AE’s which might be _associated_ with a drug, but without having to rise to the level of appreciable evidence of causality.
I may be wrong, but it sounds like you are invoking some version of the “drowning in data” argument. For that to be credible to me, I would need to see examples in which, as a result of companies making use of the old CBE rules, warnings were added that had any negative impact on anyone.
Frankly, I don’t think there is a single such case. Like a lot of the pro-preemption arguments, it is based on invoking circumstances that never actually happen.
That sais, I would be happy to learn I am wrong if there are relevant examples. It would be service to all of us to test these presumptions empirically rather than ideologically.
Jack2
Well lets look at Vytorin.
A recent trial came up that showed an increased cancer risk in the Vytorin arm. If Vytorin was a brand new drug (and not a combination product) I’d be more concerned than I am right now. But (to the best of my knowledge), the individual components don’t carry this risk. Other statins don’t carry this risk.
But only one entity really knows the full story - the FDA. Merck might know most of the risk for simvastatin, and Pfizer may know most of the risk for atorvastatin. However, neither Merck nor Pfizer know all the AEs for their product because they don’t know the AEs reported directly to the FDA (that’s my first point). On top of that neither Merck nor Pfizer knows any of the AEs reported for the other companies product (that’s my second point).
Only the FDA knows the complete risk for individual product (although I concede that the companies know an awful lot about their product), and only the FDA knows the complete risk for a class.
Knowledge of the full class could allow for greater power to detect safety trends, or knowedge of the full class could give you a broader perspective to ignore false positives.
Let’s take Chantix. There’s talk on this board all the time about rare but serious psychotic AEs with Chantix. Let’s say Chantix was in a class of meds with 4 other meds (it’s not, but let’s just say it is, since it has a safety controversy of the exact type relevant to preemption). You work for the FDA and it’s your job to put the warning on the product. If you put the warning on, people might not take a product proven to help people stop smoking. If you don’t put the warning on you expose people to this risk without warning. The first thing I’d do is look at the other meds in the class. Do they carry the same risk? If so, I’d feel more comfortable about adding the same warning to Chantix. If they didn’t, I’d feel more confident writing off these reports as false positives. Pfizer can’t do that though - all they have data on is Chantix. Only the FDA can do that.
Justice in Michigan
Jack2 - Help me follow this to see if we see things similarly.
Some # of AEs are reported to company and _not_ to FDA, yes (until FDA receives required reports from company). So there may be at least a few weeks lag time. That may or may not have any significance - depends on the situation. Certainly, a lot of bad things can happen to a lot of people in a few weeks. But the point is that there are time frames during which company may have AE data that FDA does not. Yes?
Assuming the AE data comes largely in the form of medwatch reports, it is certainly possible for companies to do relevant analyses first, or to camoflage known risk data. The fen-phen case is famous for “camoflaging” valvular heart disease behind other, known and expected AEs. At least as I read the story, there is no question that company knew about the problem and FDA did not. Took some folks in South Dakota and eventually Mayo to get FDA to look at what was, in essence, disguised. Company was “in compliance” - in name.
The Baycol case leads me to a few further points in what you write. As we now know, Bayer used a FOIA to get FDA’s own Medwatch reports comparing rhabdo rates with statins, including Baycol. FDA had not done this analysis, at least not yet It turned out - and Bayer knew it - that Baycol at least ast.4 had higher rates and an interaction problems with fibrates different from other statins.
So:
1. Here is an instance where company _did_ get data for competitors’ AEs (this specific one).
2. They learned, as internal memos suggest, that Baycol had greater problems. They did not relay the results of their analysis to FDA. Could FDA have done it? Yes. Did they? Not until some time. Should Bayer have passed on what it knew to FDA? Was it obliged to? Or was it better just to “wait and see” what FDA would do?
3. This is also an instance in which one member of the class was clearly more dangerous, at least at rx’d doses, than others. So your analysis above re: the class would have missed the higher risks of Baycol, yes?
Justice in Michigan
The moral of these stories is that, in both fen-phen and Baycol cases, FDA had “the data” but did _not_ know what companies knew - and what they did not relay.
Both companies were “in compliance” with FDA reporting regulations.
I don’t think DOJ pursued criminal action against either one.
In circumstances like this, does it make moral sense to anyone to take away the right to bring suit by victims of these drugs or their survivors?
If your answer is no, you are against FDA preemption.
Former pharma Marketing Exec
JIM and Jack2 - this is a very productive thread.
I guess the problem with reporting AE’s is that not all doctors report them. You would be amazed at the number of doctors who have quite frankly stated they do not have the time. So, I have often thought that the number of reported AE’s is much less than what it really is.
When I did some clinical work in the past, I remember being told that the paper work to complete it was arduous and time consuming. The process itself is very time consuming. In the case of medical device the device has to undergo thorough testing to determine did it fail or was it used improperly?
Then of course take the instance where during the clinical phases of the drug testing the company is the only one who has access to all the data. We know what has been withheld from the FDA with regards to clinical trial information.
Additionally, having worked in clinicals before we do get access to the FDA AE stats, so we do see what is happening with competitor drugs, but not during clinical development stage.
However, we do get information from the primary physicians who are willing to talk. So very often we can hear what is happening with a competitive drug before the trial data is submitted.
Compliance in all aspects of the process is an issue….
Justice in Michigan
For anyone who has any doubt about the relationship between the new CBE standard and preempiton, the Drug and Device Law blog concludes with the following in their post on the new CBE rule:
“And, in a sentence that may occasionally prove useful in litigation [meaning, defense of company], the FDA writes that “at least when a sponsor did not meet the standard to change its labeling through a CBE supplement under this rule to include the warning a plaintiff alleges should have been added to labeling, State law liability that is premised on a failure to warn is preempted.” Id. at 24. [Hat tip to DDL]
In other words, FDA is saying that a company cannot be held liable for “failure to warn,” if the risks about which they did not unliaterally warn do not rise to the (new and higher) criteria that the new CBE rule sets out.
It cannot get much clearer than that, and it supports Jaynesday’s early surmise on this thread that the new CBE rule is a kind of “preemption in miniature.”
Just A Thought
Under preemption these have to become civil liberties cases, don’t you think?
Jack2
Hey JIM,
Sorry for taking so long to get back to you.
I really don’t know how long it takes an AE to go from the company to the FDA. I know if I hear about an AE I need to report it in 24 hours, but I don’t know the lag between my internal reporting and then my company’s internal group reporting the AE to the FDA. Clearly, it must take some amount of time; I don’t know if it’s a day, a week, a month etc.
Also, yes, anyone can get the information from the FDA because of the FOIA. On the other hand, in FORMER’s first post in this thread he says the new rule will undermine patient’s right to total knowledge (I think he would conceed total knowledge is impossible, but he would like to strive for more knowledge). By the same token anyone can contact the FDA for this information - not just the company.
As for the rest of your two stories I think it falls into one central theme. The FDA may have all of the data. On the other hand, the FDA doesn’t employ multiple people all day every day just to think about one product, like the pharma company. I concede that fact.
Justice in Michigan
Just on last bit - of course, that’s true. The question is whether the companies involved - having spent the time and learned what they learned - were or were not obliged to pass that on to FDA? Or were right to conceal it.
Meg
Earlier, someone mentioned criminal trials for pharmas that promote off label marketing , hide lethal side effects. Has this ever happened, as I am trying to get the AG to take this step against Lilly against all those killed by Zyprexa.
There was also mention of the “quality” of the FDA. It is not always (but often) pharma hiding the negative results of clinical trials in order for a drug to be approved, but the FDA - in industry’s pocket - NOT acting on information that it has. For example, FDA knew long before it put on any labels or announced to the public, that Lilly had been required to place a warning for diabetes, hyperglycemia, and death in both Japan and the UK. The FDA did nothing about warning the American public for well over a year after that news was available to them. So if there is pre-emption, victims or their families may not be able to sue, but it still leaves a failed agency not protecting the public health.
Jack2
JIM, i agree you can’t defend concealing safety data.
Justice in Michigan
Meg - Criminal trials for off-label marketing are few and far between - Neurontin is the best known. There have been very few others.
Re: FDA, read thread on preemption if you have some time! But, with your conclusion, yes, there is an Alice-in-Wonderland quality in investing preemptive power in an agency which - as every few weeks another major study concludes, including those commissioned by FDA itself - is “broken.”
As the current FDA Commish said (one of my favorite quotes): “Peril exists.”
WEL
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