Former FDA Lawyer: Preemption & The Flood Gates
22 CommentsBy Ed Silverman // October 31st, 2008 // 11:38 am
Two days ago, the House Committee on Oversight and Government Reform released a report saying FDA career officials strongly objected to Bush Administration drug labeling regulations that would preempt state liability lawsuits. And on Monday, the US Supreme Court reviews a preemption case involving a Wyeth drug (back story). So the American Lawyer spoke to Sheldon Bradshaw, a former FDA chief counsel, who oversaw changes in label regulations before joining Hunton & Williams. This is an excerpt…
AmLaw: What’s your initial reaction to the House report?
Bradshaw: My reaction is that frankly the report grossly exaggerates the level of dissent among career officials to the new regulations. Waxman cites two or three individuals who raised objections in an agency of thousands…More important, senior agency officials had to sign off on the regulations before they were adopted. The report just completely ignores that fact.
AmLaw: The report basically accuses the FDA of adopting a pro pre-emption stance to help drug companies in litigation. Do you think Waxman intentionally released it so close to the Wyeth arguments?
Bradshaw: Clearly. Its sole purpose is to sway the Court in Wyeth v. Levine. And there’s irony in that, since the report criticizes the FDA for advancing pre-emption in order to prevail in litigation. That’s exactly what this report is intended to do.
AmLaw: Let’s go back to Wyeth. The drug’s label warned that injection into an artery could cause gangrene (though it didn’t rule out using an injection into a vein), and the FDA had approved that label. So what is Diana Levine’s claim?
Bradshaw: The plaintiff is saying there should have been a warning on the label saying never to use the injection technique. But what Waxman doesn’t appreciate is that if the Court rules for Levine and says the company should have added that warning without FDA approval, it will open the flood gates…Over-warning will become a huge problem and a huge burden on the FDA.
Anne
As a consumer, I for one would like to see the floodgates opened.
Justice in MI
It is interesting that in the DDL post on this, every supporter of preemption noted (there were four) comes from the Chief Counsel’s Office - Troy, Masoudi, Ray, and Bradshaw.
The impression one gets is a policy more or less pushed down on those at FDA who know better.
I happen to know of others - in ORA and elsewhere in FDA - whose views echo and expands those quoted in the House report. I can also report there will be many, many more coming from rand and file FDA who echo their views. Stay turned.
Justice in MI
p.s. “signing off” on a report does not mean much in such a context, as everyone knows who has been in one…..
Jaynesday
“Over-warning will become a huge problem and a huge burden on the FDA.”
The burden *should* be on the FDA; more specifically on the product manufacturers so that under-warning is minimized and the sacrifice isn’t born by the consumer. Who are we serving here?
The result of under-warning means that lives, livelihood and health are lost for those that might have a surprising and unexpected adverse reaction to the product they had hoped would help them.
I understand that some people will be denied a product that could have helped them. This is the manufacturer problem to solve not the consumer’s burden to bear.
It is not ethical to sacrifice some in our society so that others can profit - when the sacrifice can be avoided. Preemption will allow this unethical sacrifice to expand.
Tighten the reigns on the manufacturer - don’t blame the consumer. Cause the manufacturer to employ their creative talent to produce good product with proper labels that benefit all that use it. You may say it can’t be done, I say it can be done better.
Don’t free up the manufacturer, especially the bad players, to the strict controls that these critical products require. *Intentionally* force quality, proper design, safety, responsibility and accountability where it belongs; *squarely on the manufacturer*.
Can the FDA do it? Most would say no right now. Does it make sense then to employ preemption right now? Please answer the question.
I say a “huge problem and a huge burden” is when you have to take your loved one off life support due to a poorly designed product.
I say a “huge problem and a huge burden” is when you can’t work any more because of the ill affect of a known poor design.
I say a “huge problem and a huge burden” is when no one trusts the pharmaceutical industry any more because they were given the easy road in 2008 by our politicians and Supreme Court.
A “huge problem and a huge burden” on the FDA? I think not.
Brian Herrington
I agree with Anne. First, I don’t think there will be a flood of over-warning. Second, I don’t like the idea of the FDA becoming the absolute insurer of my health vis-a-vis prescription drugs and then giving me no recourse when those drugs harm me.
pharma PR hack
Overwarning will become a huge burden…. I think that isn’t at all supported in reality safety concerns we have seen arise in biologics and small molecules alike in the last few years- or even this week.
There is no doubt that with a great deal of illnesses, that is a risk consumers would be willing to take but the amount of warning cannot be overemphasized for the physician/caregiver to be able to put it into the context of the disease process and options available.
Jaynesday
So there are two choices over-warn or under-warn.
With O-W some people are told about the risk, decide not to take that particular product and have to continue to suffer or they may die. Unless they take a different product that does help them.
With U-W some people are not told about the risk, expect to get better but suffer or die.
Which is the worse of the two evils?
Doug Bremner
Show me one doctor or educated consumer who is in favor of this. It seems like the whole thing was concocted by lawyers.
Jim
Jaynesday
That simple logic explains the issue beautifully.
Justice in Mi
What the FDA report repeats is that OW is mythology, like much else that has been used to defend preemption.
Just A Thought
It was good to see the FDA is not going the same route with ***Genzyme as they did with Dilantin NMP. Dilantin NMP has still not been addressed a year later. It is a continuing horror story. Burden is being willing to trade anything for regaining your health and for making sure bad practices are ended. Burden is knowing that your government is willing to allow collateral damage in unsuspecting consumers.
***FDA panel backs new version of Genzyme drug:
“The FDA decided the new version would have to be evaluated as a separate product because of major differences in the manufacturing process.”
http://biz.yahoo.com/ap/081021/genzyme_fda_panel.html?.v=1
Bittersweet, ain’t it?
Best to keep in mind that newer is not always better.
Nathan
Jaynesday writes: “With overwarning some people are told about the risk, decide not to take that particular product and have to continue to suffer or they may die.”
The problem is far worse than that. Drug warnings are becoming like “the boy who cried wolf.” There are just so many warnings that people generally don’t believe the warnings anymore. I genuinely can’t tell what the “serious” risks are by reading standard drug labeling.
I’ve refered to it many times in this debate, but has anyone looked closely at the warnings associated with Naproxen? Read it carefully (link below) and then let’s have a discussion about whether overwarning is a problem. Does anyone take that information seriously before taking Naproxen?
http://www.fda.gov/cder/foi/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf
Someone
Nathan,
You are a simpleton!
I take all warnings seriously.
You are not and have never been sick. I hope you get diagnosed soon one day, you could use a dose of enlightenment.
Jim
Nathan
Your argument makes the case against preemption, it undercuts the over warning argument that the pro-preemption advocates have been espousing as being a cause for concer.
Nathan
Someone and/or Jim,
Did you read the link I posted? If so, let’s talk.
Read the list of side effects (below) reported to be associated with Naproxen (Aleve) and then let’s talk about over-warning. Do you think these warnings accurately reporesent the dangers associated with this over-the-counter drug? Do you think anyone takes these warnings seriously?
—————
anaphylactoid reactions, angioneurotic edema, menstrual disorders,
605 pyrexia (chills and fever)
606 Cardiovascular: congestive heart failure, vasculitis
607 Gastrointestinal: gastrointestinal bleeding and/or perforation, hematemesis, jaundice,
608 pancreatitis, vomiting, colitis, abnormal liver function tests, nonpeptic gastrointestinal
609 ulceration, ulcerative stomatitis
610 Hemic and Lymphatic: eosinophilia, leucopenia, melena, thrombocytopenia,
611 agranulocytosis, granulocytopenia, hemolytic anemia, aplastic anemia
612 Metabolic and Nutritional: hyperglycemia, hypoglycemia
613 Nervous System: inability to concentrate, depression, dream abnormalities, insomnia,
614 malaise, myalgia, muscle weakness, aseptic meningitis, cognitive dysfunction
EC-NAPROSYN® (naproxen delayed-release tablets), NAPROSYN® (naproxen tablets),
ANAPROX®/ANAPROX® DS (naproxen sodium tablets), NAPROSYN® (naproxen
suspension)
17
615 Respiratory: eosinophilic pneumonitis
616 Dermatologic: alopecia, urticaria, skin rashes, toxic epidermal necrolysis, erythema
617 multiforme, Stevens-Johnson syndrome, photosensitive dermatitis, photosensitivity
618 reactions, including rare cases resembling porphyria cutanea tarda (pseudoporphyria)
619 or epidermolysis bullosa. If skin fragility, blistering or other symptoms suggestive of
620 pseudoporphyria occur, treatment should be discontinued and the patient monitored.
621 Special Senses: hearing impairment
622 Urogenital: glomerular nephritis, hematuria, hyperkalemia, interstitial nephritis,
623 nephrotic syndrome, renal disease, renal failure, renal papillary necrosis
Source: http://www.fda.gov/cder/foi/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf
Jaynesday
Nathan - I’ll be honest with you. The first words I read - “anaphylactoid reactions” caused me to judge this drug as one I would not take. The difference btw you and I maybe is that I’ve experienced a loss due to a poorly designed device so I will read labels, check the internet, the FDA sites and quiz my doctor relentlessly before I am administered any new drug or device. I’ll even check to see who the manufacturer is and review their worthiness to take my dime. I’ve also decided to do my best to live a healthy life style. I will avoid at all costs being in a position that I have to trust a pharmaceutical company with my health or life.
I realize the good that they do, how important they are for our society and that most are reputable, but it doesn’t take too many bad apples to spoil the barrel. And when those bad apples can take your money and your health and then look you straight in the eye and tell you they aren’t accountable, I’m sorry, that’s the definition of vile.
Nathan
Jaynesday writes: “The first words I read - “anaphylactoid reactions” caused me to judge this drug as one I would not take.”
That’s exactly my point! The drug in question is Aleve — a drug you can buy at Walgreens. It’s not a dangerous drug. But the countless liability lawsuits against our industry has given us a “cover our butt” mentality that entices us to list every concievable side effect with the hope of lowering our liabilities in case we get sued. Do you know how many millions of people take Aleve every day to get rid of a headache or minor arthritis pain? How many of them complain of anaphylactoid reactions, angioneurotic edema, pancreatitis, vomiting, colitis, etc? None. Drug warnings are out of control and getting worse all the time. They are quickly becoming irrelevant.
Jaynesday
Nathan, you got me on that one. I didn’t look at the name well enough. I have to qualify, I an not concerned about an over the counter product. If it was a prescribed drug or device that’s another story.
Justice in MI
Bottom line - the officials at FDA who see all this up close reiterate that companies do NOT defenisvely underwarn. They go, instead, for minimal warnings in most cases - and certainly for blockbusters. A significant warning that a competitor drug doesn’t have can “kill the drug” in industry lingo. So it is best avoided or minimized.
Mike
Label warnings are the Tower of Babel.
How many medications include in their labeling or packaging such helpful wisdom as “…..may cause constipation, may cause diarhea…”
Such information is no information at all. Of course, those notations are all driven by reported adverse effects. But there isn’t necessarily a cause and effect, and the timing of some unrelated malady becomes determinative in the eyes of the system.
How did this system morph into one that would today not approve aspirin if it had to go through the NDA gauntlet? The risk/reward is absurd - therapies that would make a meaningful improvement in the lives of many are prevented from use because of concern that a few might suffer….and that side effect profile generally is trivial compared to the root disease. The tyranny of the minority.
laura
“How many medications include in their labeling or packaging such helpful wisdom as “…..may cause constipation, may cause diarhea…”
Those are easy warnings, they’re not going to discourage people from buying or doctors from prescribing or surgeons from using the product.
But consider this scenario…what if a product that, even by the sales reps admissions, required “babysitting” in order to get a surgeon to use, a product that is often used at the spur of the moment, without pre-surgical preparation to determine if it is appropriate for that patient…what if that product should have included a warning that, if the patient is allergic to an integral ingredient in it, very serious, even fatal reactions can occur. But, because the product is often used at the spur of the moment (precluding allergy testing to determine its appropriate use), and because the reps already have a very difficult time getting the surgeons to use it, and because this is a very expensive product that generates a major portion of income for the manufacturer, adverse events are underreported to the FDA, clinical trials are manipulated in order to assure positive outcomes and surgeons are not provided information for dealing with adverse reactions (that would admit a problem, and that is something that the manufacturer wants to keep secret)…Should that product’s manufacturer be left with no accountability?
If your answer is “no” to that question, then preemption is an immoral, perverse policy that should be overruled.
That “scenario” is a reality for my family and I’m certain that a semblance of that scenario is a reality for many others in America. Should we be left with no remedy? Should the drug and medical device companies be left with no accountability?
Sometimes it is hard to see the forest for the trees, but sometimes the trees are exactly what we need to see.
M Gallo
How can we assume the Supreme Court knows better than the two juries involved in the Levine case. Even our physicians, who know more about medicines and their side effects are agreeing with Ms.Levine They certainly know more than Mr.Scalia,Roberts and Thomas. I wonder if the justices know of any other drug that took similar situations into consideration , and did the right thing. Such was the case of Vistaril. It no longer has instruction for IV push.Pfizer removed it because of the gangrene issue. If Pfizer could do it,why couldn’t Wyeth? I keep thinking about the Women’s Health Initiative study that came to a screeching halt when they found out how dangerous Hormone Replacement therapy really was. Oh yeah…, that too was a Wyeth drug. This company has an obvious pattern.