FDA Staff Objected To Preemption Policy: Report
27 CommentsBy Ed Silverman // October 29th, 2008 // 11:29 am
Key FDA career officials strongly objected to Bush Administration drug labeling regulations that would preempt state liability lawsuits, according to a report just released by the Committee on Oversight and Government Reform. The staffers viewed the justifications for the regs as “false and misleading’ and warned the changes would deprive consumers of timely info about drug safety, the report concludes.
The internal documents, which are being released just days before the US Supreme Court on November 3 hears a preemption case (back story), show that FDA career officials asserted the regs were based on a “false assumption,” “naïve to what actually occurs in practice,” relied on “gross overstatement,” and made “false and misleading” assertions, according to the report (here it is).
Preemption is the legal notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. The court’s decision, therefore, is being closely watched because its ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.
In its report, the committee writes the FDA rewrote drug labeling regs in 2006 and 2008 to restrict the ability of drugmakers to disclose new safety risks without prior FDA approval. The agency also added a lengthy preamble to the 2006 rule in favor of preemption of state lawsuits. The changes to the labeling rules are known as the “changes being effected,” or CBE rules.
The committee maintains, however, the documents show that the FDA’s Office of Chief Counsel, which was headed by Dan Troy, who now works at Glaxo, ignored warnings from FDA scientists and career officials that “the preemption language was based on erroneous assertions about the ability of the drug approval process to ensure accurate and up-to-date drug labels,” according to its report.
Here is written comment from John Jenkins, who heads the FDA’s Office of New Drugs: “Much of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis. We know that such an assumption is false…W know that many current approved drug labels are out of date and in many cases contain incorrect information…It is unwise to suggest that FDA approved labeling is always up-to-date and always contains a full and complete listing of all pertinent risk information.”
Here’s reaction from Jane Axelrad, associate director for policy in the FDA’s Center for Drug Evaluation and Research, who wrote to agency political appointees: “There are continued references to sponsors ‘disclosing too much’ risk information and its adverse impact…We rarely find ourselves in situations where sponsors want to disclose more risk information than we think is necessary. To the contrary, we usually find ourselves dealing with situations where sponsors want to minimize the risk information.”
The report continues: “The documents provided to the Committee show that there have already been detrimental impacts from the 2006 rule requiring FDA approval before changes can be made to the highlights section of drug labels. In 2007, FDA received two requests from manufacturers seeking to immediately add safety information to their drug labels. Both requests concerned new risks that were so significant they needed to be included in the highlights section of the label. However, in both instances, the manufacturers were prohibited from promptly updating the drug label.”
One episode involved a three-month delay in changing the label for Tykerb, a Glaxo drug approved to treat certain forms of advanced breast cancer in combination with other cancer drugs, although the drugmaker sought FDA permission to revise the approved labeling to include the additional adverse events of interstitial lung disease and pneumonitis.
The other concerned Levaquin, a Johnson & Johnson antibiotic approved in 1996, although the entire class was required last year to include a warning about the risk for liver damage. In November 2007, J&J submitted a supplement to strengthen the warnings pertaining to liver toxicity, however, a three-month delay ensued.
Justice in MI
Finally, finally, finally, we are hearing what many of us know, have been trying to articulate, but needed the people “on the inside” to help us say it. This is a landmark day. Whatever the Court decides, this report and the statements it includes will stand alongside it - supporting or damning. And everyone will know it.
Many within industry know precisely the same truths from their side of the compliance/application process. We who oppose preemption have been hoping that they, too, will speak out, although we fully respect the risks involved for them personally. We do not want martyrs. Many, in fact, have spoken in contexts that would not be hurtful to them.
Let truth prevail.
Justice in MI
This section that Ed cites is, indeed, chilling. The larger disaster the preemption will yield is already happening in bits:
“The documents provided to the Committee show that there have already been detrimental impacts from the 2006 rule requiring FDA approval before changes can be made to the highlights section of drug labels. In 2007, FDA received two requests from manufacturers seeking to immediately add safety information to their drug labels. Both requests concerned new risks that were so significant they needed to be included in the highlights section of the label. However, in both instances, the manufacturers were prohibited from promptly updating the drug label.”
If anyone isn’t clear, this is a result of the preemptors raising the bar on what companies were obliged to do to change labels.
laurie
“We know that many current approved drug labels are out of date and in many cases contain incorrect information…It is unwise to suggest that FDA approved labeling is always up-to-date and always contains a full and complete listing of all pertinent risk information.”
This is the key argument against preemption. The FDA is an agency that has admitted and has shown that they are not up to date on warnings, proven in recent drug failures. To make them the gold standard on which to base drug safety is reckless.
Justice in MI
Agree with Laurie, but would add it is only one bit of the key argument. The entire representation of FDA - what it does, what it can do, how it works - has been systematically distorted in the preemption arguments. With regard to reality, they have pretty much been reckless across the board. And it appers that lives have _already_ been unnecessarily put at risk (or worse) as a result, as the cited bit above suggests.
Craig
Ed: Thanks so much for bringing this to the forefront. With all the election hoopla going on, this preemeption issue is being pushed to the back pages. It is such a signficant issue for our justice system. Now knowing the true story, it amazes me how the FDA regulators were in complete disagreement with the preemption wording, but Bush and his cronies damn the torpedoes. And here i had thought the actual regulators were behind this, but come to find it is the Office of General Counsel manipulating the system. Politics at its finest.
Jaynesday
Please join us in alerting the unaware American public of this impending travesty. Contact your Congress person now. Tomorrow you may forget. To help you do so you can go to the site provided by the Americans for Drug and Device Accountability - http://pharmaccountability.org/
On the Links page you will find a link to your Congress person and a letter template asking for his/her support on this issue.
Preemptors are still confident that they can sneak this past us. Do your part to insure that they don’t.
Thanks for looking out for your friends and your families now and in the future.
BP Watch
Preemption is such a joke. The Big Pharma companies have demonstrated over and over again that they have little regard for the public welfare and the highest regard for profit. For this reason, we have seem important data not given to the FDA, hidden from the FDA, or denied altogether by the companies because they don’t want to risk limiting their market. Just think - fen/phen, HGH, Vioxx, Avandia, Celebrex, Zyprexa, Seroquel, Risperdal, Zetia, Vytorin, etc., etc. How do the companies think they could possibly be held harmless when they aren’t honest and truthful? They’ve dug their own hole by their public negligence. They just don’t want to be held accountable. Prosecute them for their deception and fraud and hold them responsible.
The other big joke is companies thinking that off-label promotion is covered by free speech. Pharma is a reulated industry, so it’s high time they started following the regs. They get caught, deny any wrongdoing, pay a fine out of the company funds, and the execs get off free. What’s wrong with this picture? No acceptance of responsibility and no accountability for their actions. make them pay personal fines, put them in jail for fraud, throw away the key.
Someone
I can add to the list of drugs where data has been withheld, or misrepresented.
Two big cancer drugs, Gleevec (Imatinib) and Tasigna (Nilotinib). For Tasigna there is the whistle blower case where the clinical trial statistician at the drug company lost his job for reporting that the data from the clinical trial was being misrepresented. This resulted in a Black Box warning for that drug.
Can you imagine if Preemption were in place and a patient died of a heart attack. There would have been no recourse to go back to the manufacturer and the patients would have never known of the risk.
Unacceptable! Sign the petition and write your congressmen.
http://www.pharmaccountability.org
Jim
It’s encouraging to read that some Government Agency officials actually believe the role of the FDA is to promote Public Safety and not Corporate Profits.
Consumer Joe
Believe me, this is not about the preventing drug/device companies from putting new risks on their labels. I’ve worked in industry R&D, and there is consistently great pressure from powerful marketing managers to minimize potential risks.
Justice in MI
Just on this piece from BP Watch:
“Prosecute them for their deception and fraud and hold them responsible.”
Preemption would not prevent companies for being prosecuted by FDA/DOJ for criminal actions. HOWEVER, as has been said many times here, that almost never happens. Rather, once FDA clearly has the goods on a company, we have settlements, remedial plans, warnings, and that’s about it. Even a misdemeanor admission of responsibility is rare. From an FDA perspective, this is sufficient - the drug is withdrawn or a label is changed. They are not a police force. For the company, they escape admission of wrong-doing and all the further discovery might unearth and make public. A “good deal” all around.
Except that those who may have been injured have no means of compensation whatsoever, and no day in court to determine if perhaps they should have such means.
Melody
BP Watch–
Missing from your list of ’suspect’ drugs is perhaps the most dangerous of all–rDNA insulin. The bar for its approval was incredibly low (did it lower blood glucose). The manner of categorizing ‘adverse events’ is convoluted–preventing red flags rather than raising them. The disease and patients using this drug are easily targeted as blameworthy. And because it has successfully remained beneath the radar for so long, no one considers it when compiling a list such as yours. Insulin (both natural and rDNA) has always been among the most dangerous of drugs. The nature of the disease treated by the drug is such that even if/when adverse events occur, insulin manufacturers have escaped notice.
I, for one, certainly hope pre-emption fails. It has long been my dream that someday, someone will take a look back at the approval and marketing of rDNA insulin–and subsequent, unheralded adverse events–and hold the producers liable.
FDAer
Peter Pitts at Drug Wonks has the most laughable blog on preemption that I’ve ever seen. He starts out and ends claiming that those against preemption are now running scarred.
His whole argument is that the quotes released by Waxman simply shows that debate is allowed and that this doesn’t change the validity of preemption.
I nearly fell out of my chair laughing. The ‘debate’ has been entirely one sided and is a directive from above.
If Mr. Pitts and Pharma believe in robust debate then pull the holds from the whistleblower protection act, or at the very least the muzzle from FDA reviewers even talking, and definitely allow all the data and the complete reviews of drugs be made publicly available.
Just wait. There’s enough damages that have been done by a number of individual drugs that haven’t come out yet that will put Vioxx and Phen-Fen injuries to shame.
Of course that’s one of two reasons why Pharma is so keen on preemption in the first place. In case anyone is interested that’s because with preemption they can get even more dangerous drugs on the market, because of course FDA said it was safe enough if you label it.
FDAer
Justice in MI
As, for one, _am_ certainly running scared. I believe JAMA and NEJM when they call preemption a cataclysm for public health and industry accountability.
The quotes Waxman cites, btw, were not written for public consumption. They were internal FDA communications, subpeonaed by the Oversight Committee. What emerges is the picture we’ve heard described before - an agency essentially being run out of the Chief Counsel’s office and a few loyalists, and over the instincts and wishes of a large proportion of line reviewers and even higher management.
I must agree - let’s have as robust a debate as possible. All FDA staff and all industry people who are directly responsible for regulatory affairs and resposnes. Since the report confirms that the preemption argument is entirely out of touch with the reality of the ways things work, let’s put that question to an empirical test.
Otherwise, it is faith-based policy (putting best face on it).
Jaynesday
Mr. Pitts also put his attack against the FDA staff article on the WSJ site. I’ve asked him to defend preemption. So far no response. There seem to be a number of misguided folks there also.
Doug Bremner MD
Probably mostly pinstrip types. Thanks for putting the pharmacountability web site up. There is also a good info page at druginjurywatch.com. I might point out that preemption appears to be the brainchild of Dan Troy, who went from counsel for PhRMA to counsel for FDA, where he filed friend of the court briefs on behalf of pharma because ‘FDA has an interest in drugs we approved.’ When the scandal got to much he went back to working for Pharma. Just thinking about the revolving door is making me dizzy. Also, since 25% of drugs end up with a warning for a side effect that was unknown before FDA approval, that means that there is no way FDA can know about all possible side effects, and they know that, hence their complaints. The whole thing just boggles the mind.
Another thing, I have talked to journalists and they are not interested in writing about it because they can’t find a way to explain it and make it interesting for the average joe. Something to chew on.
Lisa Van S
Dr. Bremner,
Tom Woodward, who lost his daghter to a zoloft induced suicide, was quoted in the Denver Post. “Placing Dan Troy in charge of FDA Preemption is like putting John Gotti in charge of the Dept. of Justice”…
Doug Bremner MD
Lisa Van S: Great quote. Couldn’t agree more. Whadya wanna bet that the main strategy of the pro-preemption crowd is just to sit back and let everyone fall asleep and let their pro-preemption legal ruling just slide right on through.
Lisa Van S
Peter Pitts feels quite safe spewing his words via the Internet, He sang a different tune in Feb. 2004 during the FDA hearings on antidepressants in children. Maybe he was uncomfortable sitting in a room with a Columbine Victim who had been shot more than 13 times, or a Woman whose husband hung himself after being prescribed Zolft by his P.P. for the treatment of insomnia, or the Mother of a 14 year old who became suicidal after being prescribed effexor for Migraines,.. The Teens Neurologist was conducting a trial, payed for by Wyeth, for the treatment of Migraines in adults. Peter should ask himself this important question,.. How will I be greeted when I reach the Pearly Gates of Heaven?… How will I be judged by my creator?
A.M.
Jaynesday,
What FDA staff article are you talking about? Could you provide a link or better yet a copy of the article itself if it’s short?
A.M.
Found It
http://online.wsj.com/article/SB122529821388980687.html#articleTabs%3Dcomments
23 hours ago
walter rhett (your comment)
This echos what an FDA staff reviewer commented 2 days ago on the WSJ blog on the Wyeth / Levine case.
see http://blogs.wsj.com/health/2008/10/27/wyeths-take-on-wyeth-v-levine/
I am personally opposed to a broad interpretation that FDA review justifies preemption.
In my opinion this requires a number of assumptions.
1) Reasonable efforts have been made to adequately study the drug
2) All relevant data has been submitted to the FDA
3) The sponsor has not mislead the FDA
4) Reviewers have the appropriate expertise and resources including time
5) There is no interference with conducting reviews by FDA management for example by pressuring or threatening the reviewer
6) FDA management has not intentionally inferred with requests for information, the review process, or labeling recommendations
As an FDA reviewer I can attest that not a single one of these or other necessary assumptions are necessarily valid. Even as an expert I frequently find that approved labeling is written in such a way or changed by upper management so that there is simply not enough information provided for me to make an informed decision for drugs I may need to take. If I as an expert am unable to utilize the labeling in order to protect my own life and the lives of my family due to intentional omissions or obfuscation by companies and FDA management, then in my opinion the typical prescriber or patient definitely can’t and there is insufficient justification for preemption.
Ronald E. Kavanagh, B.S.Pharm, Pharm.D., Ph.D.
Senior Clinical Pharmacology Reviewer (Pediatric Clinical Pharmacologist)
Office of Translational Sciences; Co-located with Division of Psychiatric Drug Products
The opinions expressed are my own and do not represent the opinions of the FDA.
Comment by Ronald E. Kavanagh - October 27, 2008 at 7:41 pm
Jaynesday
A.M.
the one I was referring to was:
http://blogs.wsj.com/health/2008/10/29/fda-official-preemption-argument-based-on-a-false-assumption/
Its actually this same article just a different audience. Peter Pitts made a feeble attempt to disgrace the article and the staff involved but some good discussion otherwise.
John Fratti
I was a very healthy 40 year old athletic male. I didn’t smoke, didn’t drink, didn’t do anything illegal. I was simply given a legal drug ( Levaquin ) and now my life has been destroyed. Ironically, I was a pharmaceutical sales rep with a masters degree. Tens of thousands of people are now crippled from Levaquin just like me. I have been disabled for 3 1/2 years. Please go to Youtube.com and type in Levaquin and see how bad this drug is.
http://www.Levaquinadversesideeffect.com
Sincerely,
John
Doug Bremner MD
my post on wsj health blog:
OK, I will be patient and read Steve’s comments. Here is a point by point response.
“The slowing of the delivery of medical progress that is resulting from the current wave of drug safety hysteria, and that will be the inevitable consequence of turning drug regulation over to the tort bar and state courts, is killing hundreds of thousands of Americans prematurely every year by denying them access to progress.”
Provide evidence for this.
“It is never the right thing to put people with the wrong expertise and goals in control of power over others, and placing drug regulation into the hands of state courts will do precisely that.”
Steve has the facts wrong. We are not ‘putting’ power in the state courts, that power has resided there for the past century, the issue before the Supreme Court is about taking away that power. And the courts will not do drug regulation, they will try cases.
“This should not be about extreme positions… That answer must be a competent, effective, responsive, flexible FDA, or a new agency built to replace it… start by rebuilding the FDA.”
Congress already had their band aid legislation for the FDA which was effectively eviscerated in the end. We have the spectacle of a Senator yelling at the Director of the FDA to tell him how much money they need to protect us from dangerous drugs or Chinese imports and he cannot answer the question.
“While trashing preemption will result in the ability of a relative few to seek justice at the state level, the unintended consequences will be devastating to many, many more.”
The implication is that preemption will allow ‘life saving drugs to speed to the market place.’ Provide evidence for this.
“The FDA doesn’t have to be incompetent and inflexible, nor does it have to be slow and unresponsive in flagging risks to protect people from drugs.”
Approval time is about six months.
“If the FDA was doing its job well, we wouldn’t be having this discussion, and there wiould be no cases regarding preemption before the Supreme Court”
I disagree with that. Any medical doctor (including those at the FDA) conversant with the literature will tell you that it is impossible to predict all of the future side effects of drugs, which is why 25% end up getting a warning *after* approval by the FDA.
Neil McLaughlin
Mark my words: the next step after this will be mandatory vaccination and treatment of adults. The new cholesterol study is one example. Forced vaccinations for health care workers, forced vaccines for all NJ school children are two more. The FDA and the Pharmaceutical companies are the same entity, and now they want to say their word is the final say. Of course they want that. And the Bush-appointed cronies like Antonin Scalia are already saying “take your suit up with the FDA”. This was Bush’s primary objective - the Federal Government answers to no one (except the Federal Reserve), and all officials are appointed by the President.
Craig Cheatham
I’m very interested in talking with some of you about this issue. Please contact me.
Craig Cheatham
KMOV-TV
St. Louis
ccheatham@kmov.com
Jaynesday
Craig, I think many here would like to talk to you but as you can imagine there might be a bit of skepticism about your intentions.
Some of us have worry for quite a while now why there is such little coverage of pharma safety issues, the FDA, etc in the major media. Maybe you can shed some light?