Jaynesday

WISDOM FROM THE PAST

2008-08-29T20:15:00.000-07:00

Here is an interview with Dr. David Graham (senior drug safety researcher at the FDA) that was held exactly 3 years ago. Seems things haven't changed much from then. Lets hope that as the dead lines for preemption approach some real change will begin to get traction.
As you read this interview you will be impress with Dr. Graham's wisdom, honesty and bravery in the face of the FDA bureaucracy.

The FDA Exposed: An Interview With Dr. David Graham, the Vioxx Whistleblower

Petition Against Preemption - Make Your Voice Heard

2008-08-25T16:46:00.000-07:00

May the word about Preemption be heard from Cost to Cost and ring in the halls of Congress. We will not stand for this loss of our Constitutional Right to be heard in a Court of Law. No organization public, private, political or judicial will stand in the way of the rights of America’s citizens.

We must get the word out to our friends and families.

Go to this site and sign the petition against preemption.

http://www.ipetitions.com/petition/fdapreemptionbadmedicine?e

COMING OUT AGAINST PREEMPTION

2008-08-16T13:13:00.000-07:00

See the attached article from Pharmalot.
The Right To Sue: A Case Against Preemption

As we approach the end of the year we see some very strong language from some very learned folks. The issue of preemption and the corporate stance is exposed to the light of common sense.

For example:
From The New England Journal of Medicine, 359:1, July 3, 2008

"Previous administrations and the FDA considered tort litigation to be an important part of an overall regulatory framework for drugs and devices; product-liability litigation by consumers was believed to complement the FDA's regulatory actions and enhance patient safety...
In stripping patients of their right to seek redress through due process of law, preemption of common-law tort actions is not only unjust but will also result in the reduced safety of drugs and medical devices for the American people."

Preemption Under Attack

2008-07-21T15:43:00.000-07:00

See this post from Pharmalot - Ed Silverman

http://www.pharmalot.com/2008/07/judge-reverses-preemption-ruling-in-paxil-case/

In the courts opinion:

Glaxo “has acknowledged that the regulations give it the responsibility for proper labeling of Paxil, and that it had the ability to make changes to Paxil’s label when there was “reasonable association” between a serious hazard and a patient’s ingestion of the drug.

“…The FDA’s current position on preemption is not ‘long standing’ but is in fact a ‘180-degree reversal’ from its earlier stance…the court, on reconsideration, gives relatively little weight to the FDA’s opinion on the preemptive effects of its regulations…Drug manufacturers have the authority to strengthen warnings without the advance permission of the FDA.

“[F]ailure to warn litigation can serve to reinforce the FDA’s regulations, which already place the obligation to strengthen the warnings on a drug’s label squarely on the shoulders of the drug’s manufacturer…

“The FDA’s statement, made several years after the fact, that it would not have approved a warning change that was never actually proposed, is speculative and will not serve as the basis for a finding of a preemptive conflict.”

Thanks Ed

Why Doctors Should Worry about Preemption

2008-06-25T18:38:00.000-07:00

From The New England Journal of Medicine
http://content.nejm.org/cgi/content/full/359/1/1
Volume 359:1-3
July 3, 2008
Number 1

Why Doctors Should Worry about Preemption -->
Gregory D. Curfman, M.D.,
Stephen Morrissey, Ph.D., and
Jeffrey M. Drazen, M.D.
-->A leading drug company may be poised to win a landmark legal victory next fall. If the drug manufacturer, Wyeth, prevails in a case soon to be argued before the U.S. Supreme Court (Wyeth v. Levine),1 drug companies could effectively be immunized against state-level tort litigation if their products that have been approved by the Food and Drug Administration (FDA) are later found to be defective.
A medical-device company won such a victory in April. In Riegel v. Medtronic,2 the Supreme Court determined that a product-liability lawsuit against Medtronic in a state court was preempted because the device had received FDA approval. Preemption is a legal doctrine based on the supremacy clause of the U.S. Constitution, which states that when federal and state laws are at odds, federal law takes precedence. Its application to state tort litigation is a radical extension of its original meaning.
Medtronic won its case because the 1976 law that grants the FDA authority to regulate medical devices contains a clause asserting that state requirements with regard to medical devices are preempted by federal requirements. Although the preemption clause is silent on common-law tort actions, the Supreme Court (with Justice Antonin Scalia writing for the Court) interpreted the preemption clause broadly to include such actions.
Unlike the law governing medical devices, the Food, Drug, and Cosmetic Act, which provides the statutory framework for the regulation of drugs by the FDA, contains no such preemption clause. Thus, in Wyeth v. Levine — which concerns a patient who lost her arm after an injection of Wyeth's antiemetic drug Phenergan — the Court will decide whether preemption of state tort litigation is implied by the law, even though it is not explicitly stated.
Previous administrations and the FDA considered tort litigation to be an important part of an overall regulatory framework for drugs and devices; product-liability litigation by consumers was believed to complement the FDA's regulatory actions and enhance patient safety. Margaret Jane Porter, former chief counsel of the FDA, wrote, "FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection."3 Persons who are harmed have the right to seek legal redress. Preemption would erase that right.
But in the past few years, the government's views have shifted, and the FDA has reversed its position, now claiming that common-law tort actions are preempted. The FDA argues that tort liability stifles innovation in product development and delays the approval process, and that lay juries are incapable of making determinations about product safety. It has been argued, however, that Congress, not unelected appointees of a federal agency, has the power to decide whether preemption should apply.
Drug and device companies have chosen an inauspicious moment to attack the right of patients to seek redress. A series of pivotal reports on patient safety from the Institute of Medicine, as well as numerous articles in scholarly journals, has put the issue of patient safety in the national spotlight. Although frivolous lawsuits should not be condoned, product-liability litigation has unquestionably helped to remove unsafe products from the market and to prevent others from entering it. Through the process of legal discovery, litigation may also uncover information about drug toxicity that would otherwise not be known. Preemption will thus result in drugs and devices that are less safe and will thereby undermine a national effort to improve patient safety.
Owing in part to a lack of resources, approval of a new drug by the FDA is not a guarantee of its safety (see timeline).4 As the Institute of Medicine has reported, FDA approval is usually based on short-term efficacy studies, not long-term safety studies.5 Despite the diligent attention of the FDA, serious safety issues often come to light only after a drug has entered the market. The FDA, which — unlike most other federal agencies — has no subpoena power, knows only what manufacturers reveal.

View larger version (41K):[in this window][in a new window]
Four Drugs with Safety Problems Discovered after FDA Approval.
Why should doctors be concerned about preemption? In stripping patients of their right to seek redress through due process of law, preemption of common-law tort actions is not only unjust but will also result in the reduced safety of drugs and medical devices for the American people. Preemption will undermine the confidence that doctors and patients have in the safety of drugs and devices. If injured patients are unable to seek legal redress from manufacturers of defective products, they may instead turn elsewhere.
In May, a Congressional hearing on preemption was held by Representative Henry Waxman (D-CA) and the House Committee on Oversight and Government Reform. As we stated in our testimony to the committee, to ensure the safety of medical devices, we urge Congress to act quickly to reverse the Riegel decision. Congressman Waxman and Congressman Frank Pallone, Jr. (D-NJ), are poised to introduce legislation that would unambiguously eliminate the possibility of preemption of common-law tort actions for medical devices. And if the Supreme Court rules for preemption in Wyeth v. Levine, which we hope it will not, Congress should consider similar legislation for drugs. Such legislation is in the best interest of the health and safety of the American public.
Source Information
Dr. Curfman is the executive editor, Dr. Morrissey the managing editor, and Dr. Drazen the editor-in-chief of the Journal. An interactive timeline is available with the full text of this article at www.nejm.org.
References

Wyeth v. Levine, cert. granted, 128 S. Ct. 1118 (2008).
Riegel v. Medtronic, 128 S. Ct. 999 (2008).
Porter MJ. The Lohr decision: FDA perspective and position. Food Drug Law J 1997;52:7-11. [ISI][Medline]
Kessler DA, Vladeck DC. A critical examination of the FDA's efforts to preempt failure-to-warn claims. Georgetown Law J 2008;96(2). (Accessed June 13, 2008, at http://lsr.nellco.org/georgetown/ois/papers/2/.)
Baciu A, Stratton K, Burke SP, eds. The future of drug safety: promoting and protecting the health of the public. Washington, DC: National Academies Press, 2007.

Drug Safety: FDA Can Not, Drug Companies Will Not, Supreme Court Doesn’t Care

2008-05-09T19:56:00.000-07:00

Three extremely important issues that everyone needs to investigate. Please review these issues for your health safety. Unfortunately it’s up to you these days.

1. The FDA commissioned an independent study titled - FDA Science and Mission at Risk - Report of the Subcommittee on Science and Technology. Nov 2007
18 negative findings were reveled, three of which are:
• The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.
• The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.
• The FDA cannot fulfill its mission because its information technology infrastructure is inadequate.
See report at http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf

2. The current state of pharmaceutical industry affairs is alarming and getting worse. Some topics:
• Imported ingredient in Herapin contaminated and caused 19 deaths.
• Merk’s drug Vioxx - FDA analysts estimated that Vioxx caused between 88,000 and 139,000 heart attacks, 30 to 40 percent of which were probably fatal.

3. Supreme Court Supports Preemption (Reigle v. Medtronic)
• Preemption explanation - a Medical Device that has been approved by the FDA is exempt from product liability law suits. Drug ruling follows this fall.

In conclusion – The FDA does not have the resources to do an adequate job of protecting the American public from dangerous products. The pharmaceutical companies compound the FDA’s failure by purposeful deception. The Supreme Court has ruled against due process of law to protect pharmaceuticals companies.

Seriously, be very careful before taking a new drug or medical device. There are many of us that can attest to the fact that unfortunately you may not know the real side affects or adverse reactions until it’s too late.

FDA Failing Public | Courts Covering Up

2008-04-27T06:22:00.000-07:00

FDA-approved Lawsuit Preemption
planetc1.com-news@8:40 pm PST By Darrel Crain, DC

Everyone seems to be picking on the poor Food and Drug Administration (FDA) these days, but for vastly different reasons. To the hundreds of thousands of victims (including dead ones) of adverse prescription drug reactions each year, and their families, the FDA is failing to protect the public. These people believe the agency should spend more time and effort making sure drugs are safe and effective before approval. Meanwhile, the pharmaceutical companies feel the FDA is a nuisance, way too fussy about drug safety details and terribly slow with approval. This, they say, deprives consumers of the latest drugs, not to mention delaying company profits.
Drug companies have long insisted that going to all the trouble and expense of obtaining FDA approval for their drugs and medical devices should entitle them to complete immunity from all product liability lawsuits. In other words, if FDA-approved drugs destroy your health or kill a loved one, get over it.
A few years ago Dr. Allen Roses, an executive vice president with drug maker GlaxoSmithKline admitted in an interview that prescription drugs are irrelevant to the health of most people, most of the time. "The vast majority of drugs - more than 90 per cent - only work in 30 or 50 percent of the people," he said.
A much different story is relentlessly beaten into the minds of the public every day by aggressive, multi-billion-dollar-a-year drug marketing. That story tells us that every human illness is a drug deficiency disease that can only be "cured" by taking the latest drug every single day for the rest of one"s life.
Imagine if those billions were instead spent on a massive public education campaign teaching the two basic, unchanging principles of human life and health: 1) Lifestyle and environmental factors account for the vast majority of health disorders, and 2) For most people the body is perfectly capable of healing itself when underlying nutritional deficiencies are corrected, toxins are cleared and lifestyle improved. But I digress.
President Bush has long pushed for preemption of lawsuits for drug companies, arguing that the expert doctors at the FDA are the only people in the country smart enough to understand these complicated matters, and the courts should not try and second-guess the all-wise FDA.
Gee, did someone forget to tell the president that the experts over at the FDA have already given notice that the agency is completely incompetent? The FDA's science board spent a year studying problems at the agency, and concluded that a lack of resources and personnel "is imposing a significant risk to the integrity of the food, drug, cosmetic and device regulatory system, and hence the safety of the public."
The new protocol for public safety seems pretty obvious: Avoid taking anything approved by the FDA.
As if things weren"t bad enough already, the U.S. Supreme Court is poised to rule in favor of drug-maker Wyeth in a case that will likely usher in total preemption of lawsuits for all products approved by the FDA.
Johnson and Johnson is only one of the drug giants salivating at the enormous windfall in store once the courtroom doors are locked to drug-injured parties. J&J lawyers are already using the preemption argument to defend the company from 3,000 women suing for serious health problems caused by its birth control patch. Injuries to women who have used the patch include heart attacks, strokes and at least 40 deaths.
One scientist within Johnson and Johnson urged the company to conduct a formal evidence-based review following FDA approval because of "an abnormally high number of 'spontaneous cases' of clotting disorders, as well as death," associated with the patch. The company never performed such a study.
To its credit, Johnson and Johnson does admit that initial drug safety data on the patch was altered using a "correction factor." This is another way of saying "we made up the numbers." But J&J lawyers swear this kind of monkey business is normal and standard procedure for safety trials, and I believe them.
Apparently it has also become normal to delete negative drug reactions from safety reports submitted to the FDA, and lie about who wrote the reports, as we discovered with the Vioxx debacle. Since the FDA does not carry out drug safety research itself, its decisions are based on whatever selective and biased reporting the companies decide to hand in.
Before being pulled from the market, Merck & Company's drug Vioxx, a pain medication described as no more effective than over-the-counter pain relievers, caused more than 100,000 heart attacks and at least 50,000 deaths in the United States, according to senior FDA researcher Dr. David Graham. The public did not learn details about Merck"s massive data doctoring until forced to open up its cooked books in courtroom proceedings.
Even when lawsuits force some companies to come clean on their dirty secrets, we must remember that the gold standard of clinical science itself, the placebo-controlled randomized trial, has been downgraded to a fool's gold standard. Over recent decades, drug companies have "streamlined" standard clinical procedures to improve chances for FDA approval.
Randomization of patient selection has been replaced with "run-up" and "pre-trial adjustment" periods, in which test subjects are removed from the study whose responses make placebos look too good or the drug too toxic. This prevents the data from being "skewed" by real-world responses.
Many of today's placebos are also fakes, doctored with chemicals that mimic the side effects caused by the drug being tested. Obviously, if the "placebo" causes adverse reactions similar to the tested drug, the drug looks much better.
In modern vaccine trials, so-called placebos can contain toxic chemical cocktails that are part of the tested vaccine, including aluminum. The adverse reactions people have to such neurotoxins are then counted as placebo responses.
As any first year student of science can tell you, a scientifically valid clinical trial demands the use of a control group receiving a placebo with zero active ingredients, without exception.
In any other industry, these kinds of creative "improvements" to established scientific protocol would be called "cheating." Drug companies have their own word for drug safety trials that violate basic rules of science, "profitable."
Lawsuits have traditionally served as the only check and balance available to shore up the shortcomings of the FDA. As things stand, if preemption wins the day and lawsuits are forbidden, the drug companies will be free to get away with murder more than ever because they will never be forced to disclose exactly how the numbers were fudged or what data was withheld to gain approval.
While preemption is a spiffy idea for the drug companies, it is grossly unfair to the rest of us and violates the constitutional right of citizens to due process of law. Perhaps there is another, more equitable strategy to pull us out of the regulatory quagmire at the FDA.
What about leaving it up to the free market? As Thomas Jefferson once pointed out, "It is error alone which needs the support of government. Truth can stand by itself."
An absolutely free, unfettered, lassieze-faire market may be the most suitable solution for the business of making and selling prescription drugs. Why not completely dismantle the entire regulatory process of the FDA? What good are lengthy and expensive drug safety trials when they get falsified in the end anyway?
Dispense with the corrupt approval process and the money saved from the trials can be reallocated to pay for courtroom expenses and settlements. This is the kind of feedback that forces companies to make safer products.
Let the pharmaceutical companies quit their whining and swallow their own bitter pill of legal accountability. Let every drug company large or small concoct whatever chemical drug it wants to, advertise whatever miraculous benefits sound good, and then leave it to the marketplace to decide what really works, what harms and what kills.
If a company profits from a drug that turns human liver to a quivering glob of goo, or kills a few hundred or a few thousand people, that company deserves to be righteously sued in a court of law. Directors at the top of any company selling deadly goods should be held criminally liable for damages. Why should dangerous and deadly medical products be treated differently than dangerous and deadly tires, toasters, tainted food, or anything else?
To the drug lords hiding in the boardrooms of the pharmaceutical houses, I say if you are afraid to stand up for the integrity of your products and face your victims in the courtroom, then switch to the pesticide business where chemicals for sale are fully intended to cause death and disability.
The time has come to unleash the free market on the pharmaceutical industry and leave it to the invisible hand of supply and demand to sort things out. But first let's make sure we preserve the time-honored tradition of due process in a court of law for those consumers harmed by bad goods.

Letter to Congress

2008-03-21T05:40:00.000-07:00

For our/your safety - please overturn the Supreme Court's ruling on Preemption for Medical Device Makers.

Here is our experience with a Medical Device Manufacturer:

Two years ago in February our mother died because she had a severe adverse reaction to a medical device that was placed in her during a routine surgery. Since her death, our family has researched the device and the company that produces the device. We have found that there are hundreds of adverse events to that device reported on the FDA's MAUDE database. Several of these adverse events have been fatal.

The company has apparently decided not to investigate these events. Their standard response posted in the FDA’s “MAUDE” reporting database to the question:

"Was device evaluated by manufacturer?"

"Device not returned to manufacturer".

This is a medical device that dissolves into the patient’s body and cannot be retrieved.

From our research we have also learned that the device is made with an ingredient that can cause severe reactions. Other products made with this ingredient contain warnings on their product labeling regarding this reaction. This medical device contains no such warning on its product labeling.

This medical device has been on the market since 1996. The company has done nothing to change its labeling to include warnings or change its formulation to prevent adverse events. My family has initiated a lawsuit against the manufacturer because we feel that it is the only way to hold them accountable for the unsafe medical device that they are profiting from. People continue to have this device placed into their bodies and people continue to react adversely to this product. We feel obligated to make the manufacturer aware that they must find out why these reactions are occurring and warn patients who should not receive this device.

Now, however, with the Supreme Court's decision in the Reigel v Medtronic case, we are apparently unable to continue with our lawsuit. The Supreme Court interpreted the 1976 Medical Device Amendment to mean that medical device companies are preempted from state claims. Senator Kennedy and Representative Waxman have publicly stated that Congress did not intend to preempt medical device companies from state claims for liability.

Having been through this experience we can tell you that we will no longer feel the same way about being admitted to a hospital where a drug or device may be use in the course of our treatment. A degree of freedom has been extended to Medical Device Companies through preemption from product liability that causes us much concern.

The manufactures must be held accountable for the products that they sell to the public. A major avenue toward that accountability has been closed and needs to be reopened.

Therefore we support whole-heartedly the amendment proposed by Rep. Pallone.

“Medical Device Safety Act of 2008,” is being circulated on Capitol Hill. The bill would amend § 521 of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to add a new subsection, titled “No Effect on Liability Under State Law,” which states: “Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.” If enacted, the amendment would apply to any civil action pending or filed on the date of the enactment of the Medical Device Safety Act of 2008.

Please support this amendment for our safety.

The Supreme Court and Preemption

2008-02-23T11:53:00.000-08:00

The Supreme Court has taken the side of the Medical Device Companies. They have decided to protect them from the harm of product liability lawsuits. Someone has convince the Supreme Court judges that the FDA does a good enough job of protecting the consumer. Good enough that challenges to the Device Manufacturer's competency are only frivolous attempts to damage their good names and keep good products off the market.

If you buy a toy made in China that uses lead paint, you can sue the company that made it if you are damaged by the product. If someone has an implant put in their body that leads to their death, don’t think that you can frivolously expect that there is any liability by the manufacturer. How silly.

Then is there any need for product liability at all? Why should car manufacturers, toy manufacturers, home shop tool manufactures, or electrical appliance manufacturers have to put up with personal damage lawsuits? What makes Medical Device manufacturers special enough to exempt them for this basic law of business? The law that says you just can’t make things that kill or injure the consumer without having to answer for your negligence.

The Supreme Court has been convinced that the FDA is more or less infallible and that Device manufacturers are honest and above board in all of their product development. We have to disagree.

GLAXO - HIDING UNDER THE SKIRT OF PREEMPTION? YOU DECIDE

2008-02-02T15:27:00.000-08:00

ITEM #1
Glaxo Wins Paxil Suicide Case Due To Preemption
See the full post in Pharmalot - Feb 2, 2008

A federal judge in California dismissed a case brought by the family of a 13-year-old girl who committed suicide while taking the antidepressant, citing a controversial rule that FDA approval of a drug preempts state lawsuits challenging safety, efficacy, or labeling. At issue is whether patients can sue a drugmaker through state law when a product has already been approved by the FDA, a notion the US Supreme Court is expected to decide after agreeing to review a different case. In the Paxil case, US District Court Judge Frank Damrell, Jr. dismissed the suit “on the grounds that, under state law, all of the claims required showing that Glaxo should have included a warning in Paxil’s
labeling in 1997 that there was an increased risk of suicidality.” And so he decided the lawsuit created “a direct conflict with the federal labeling requirements for Paxil established” by the FDA, “preempting the plaintif’s claims, according to a statement
issued by Glaxo’s attorneys.

ITEM #2

Antidepressant Studies Unpublished
The New York Times report on Jan 17,2008 -(corrected by the New York Times to not include the manufacturer of Prozac)

The makers of antidepressants like Prozac and Paxil never published the results of about a third of the drug trials that they conducted to win government approval, misleading doctors and consumers about the drugs’ true effectiveness, a new analysis has found.

PUTTING 2 and 1 TOGETHER
First we see that Glaxo is accused of "misleading" the FDA in not reporting all of their investigations prior to approval of Paxil. These investigations would likely define their product label.
The drug was approved, consumed and allegedly cause the death of at least one of its consumers.
A law suit ensued and the case was dismissed by a Federal Judge because of the "rule" of preemption. Preemption being the reasoning that says when a label is defined by the drug company and approved by the FDA, stating its capabilities and warnings, it can't be challenged by the state court in a product liability case.
Who structures the label more the drug company or the FDA? It appears in this case that its the drug company.
Of course being unattached to this case we only see what is reported by others so this is just a general view of a series of events. But generally it appears that things are not right.

The Drug/Device Companies say "Trust Me"........ Well lets verify first

2008-01-27T10:57:00.000-08:00

Antidepressant Studies Unpublished
The New York Times report on Jan 17,2008 -
(corrected by the New York Times to not include the manufacturer of Prozac)

The makers of antidepressants like Prozac and Paxil never published the results of about a third of the drug trials that they conducted to win government approval, misleading doctors and consumers about the drugs’ true effectiveness, a new analysis has found.

Trust you? No thanks I'll pass!

What would you do as CEO of this company?

2008-01-26T14:08:00.001-08:00

Things are not going well.
Your staff reports to the public that your company is failing to uphold its duty to your customers. They even say that their managers are forcing them to falsify critical reports.
Then an in depth investigation goes to the board of directors that states that the company is failing in almost every way to meet its objectives.
Some of your customers are in an uproar about how your product has failed to perform as expected.

For most companies this would certainly be the end of the line for its management and maybe even its future existence, but here’s the deal.
Your corporate lawyers have an idea that will arrange for the end of all future customer complaints. Regardless of the performance of your product you would not have to concern yourself about whether your product did its job or not. The customer will be silent and profits will sore “just trust us” they say.

As far as the Board of Directors is concerned, their plan is brilliant. First of all they won’t have to spend nearly as much money on revamping the company and second of all they won’t be bothered by those pesky complaining customers.

As you sigh in relief you think you hear the sound of a bullet whizzing past your ear. Close call

A hypothetical situation? Maybe not
Here are some facts about a company (the FDA), a board of directors (Congress) some corporate lawyers involved with the Supreme Court and the customer (You and I).

We see that the FDA is having problems with reports by their scientist on issues they are having with the ethics of the management.
Here’s what the scientists have to say.

July 20, 2006 – the Union of Concerned Scientists report:
FDA Scientists Pressured to Exclude, Alter Findings; Scientists Fear Retaliation for Voicing Safety Concerns
Public Health and Safety Will Suffer without Leadership from FDA and Congress

“Concerned Scientists (UCS) today released survey results that demonstrate pervasive and dangerous political influence of science at the Food and Drug Administration (FDA). Of the 997 FDA scientists who responded to the survey, nearly one-fifth (18.4 percent) said that they "have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or their conclusions in a FDA scientific document."

Then we have the report to the Board of Directors. It is quite a scathing report but to the company’s credit they post it on their web site. Is this so that they can publicly plead for more resources from the Board? Will the Board listen to their plea or to their lawyers?

December 3, 2007
This information is on the FDA’s site - DOCKETS (Link)
Below is just the table of contents and a bit long but chilling when you read all the “can not fulfill”, “inadequate and ineffective”, “obsolete, unstable” statements made about the condition of the FDA.

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

Corporate Lawyers to the Rescue?
The strategy of the lawyers is something called preemption. Simply stated is means that once a device has been approved by the FDA its safety can not be challenged in a state medical liability case. The basis of this idea is that the FDA should have enough intelligence and capability to assure that a product that they approve for sale is in actuality safe enough to be used by the public. Disagreements will just not be allowed. This makes the difficult task of defending a pharmaceutical company’s products much easier. Make that unnecessary.
The question is obvious, is the FDA capable enough in its present state to make these decisions? For that matter will any organization ever be infallible and without need of checks and balances?
See the link here for a simple discussion of the issue.
Preemption Watch: The Solicitor General Weighs In
Quoted within - about the case (Reigel v. Medtronic) that will decide whether preemption will be or not:

“Ultimately, we believe that the pivotal question for the justices in Riegel v. Medtronic resides in what is in the best interest of American society. Is it in the people’s interest to shield medical-device companies from product-liability claims? Would such a decision benefit patients by making more lifesaving medical devices available, or would there be adverse effects on the overall safety of devices? Is the FDA premarketing approval process sufficiently rigorous and comprehensive to justify immunization of the industry against tort claims? And if medical-device manufacturers are shielded from liability, what about drug manufacturers?”

So the question remains – What would you do?
Here we see that the staff (FDA scientists) publicize the poor ethics of their company's (FDA’s) management and the management then publishes their list of failures and weaknesses with the underlying reason being a plea for funds from the Board of Directors (Congress).
Will the corporate lawyers win the day (Preemption)? Will the Board of Directors (Congress) over rule the lawyers and support the company (FDA)? And what will happen to the customers (You and I)?

That’s the real question here. Not whether it is right for the FDA to be over-ruled by the State Courts, not whether product liability claims are too expensive for the drug companies to bear (how many billions in profit?), but whether there will be more or less of us injured and killed by products that have been tested and approved for sale by the FDA.

Even if you can make a case for only one entity being the last word on what is safe enough for sale to the public, should it be an organization that has clearly been determined to be insufficiently and inadequately staffed, funded and managed?
Will the Supreme Court and Congress allow this perfect storm to be unleashed on the American public? Stay tuned the case should be decided this Spring.
One more note, did you notice the last sentence in the quoted article above?

And if medical-device manufacturers are shielded from liability, what about drug manufacturers?”

The - what about - is axiomatic. Preemption for medical devices is an automatic preemption for drugs and probably the basis for any number of challenges to the validity of product liability as a whole.
What would you do?