Company Z makes widgets. The widgets are highly regulated by the government, so much so that any time the company wants to produce a new kind of widget, it must get explicit government approval to do so. It must show all of its widgets are safe.
The government grants its approval, Company Z sells millions of widgets, and some of the widgets end up hurting people. The people decide to sue over their hurt.
But then Company Z throws them a curve ball — you can’t sue, since the government already declared our widgets safe! If they weren’t safe, the government wouldn’t have approved them in the first place.
Welcome to the U.S. Food and Drug Administration regulatory system, which is now under scrutiny in a number of legal cases winding their respective ways through different court systems.
This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.
The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.
Isn’t that exactly what courts are meant to do, however? Act as a balance to our lawmakers and executive branch, to ensure that everyday citizens’ rights aren’t trampled by pharmaceutical special interests and huge lobbyist groups?
The core problem is that the FDA is a mess and broken. It makes many of its decisions knowing full well that they are not always in the best interests of U.S. citizens, but rather expediency — the simplest course is best. I think they make exceptions to this rule, when enough people’s lives are potentially in danger. But time and time again, we see inaction the rule when it comes to the FDA — if it ain’t “broke,” don’t fix it.
And the longer they put off fixing any particular issue that crops up with a drug, the more money the drug company makes. It may not be intended to work that way, but that’s how it is. Drug companies realize this, so also drag their heels whenever possible, since the minute the FDA makes a decision about its drug, it could tank sales:
The F.D.A. did not warn the public of the potential risks until November 2005 — six years after the company’s own study showed the high estrogen releases. At that point, the product’s label was changed, and prescriptions fell 80 percent, to 187,000 by last February from 900,000 in March 2004.
[…] “Johnson & Johnson knew that F.D.A. does not have the funding or the manpower to police drug companies,” [a plaintiff’s lawyer] said.
Which is born out by the testimony of ex-FDA workers and scientists, like Dr. John Gueriguian. He “testified that the agency did not always ask for strong warnings even if it believed a drug was risky. Companies typically oppose warnings, and the agency knows it must compromise on its requests or face years of delay, Dr. Gueriguian said.”
“We at the F.D.A. know what we can obtain and we cannot obtain,” Dr. Gueriguian said. “We have many, many problems, and we have a management system — what we can’t obtain we will not ask.”
In other words, in a sensitive bureaucracy like the FDA which is a minefield of balancing acts, you have to carefully pick your battles. Even if it means some people may get harmed due to not having all the information they should have.
This case is more complicated than I can go into here, so I highly recommend reading the full New York Times article (below).
I just wanted to focus on the point that any government agency tasked with both regulation and policing of an industry is going to be ineffective. For instance, the F.A.A. is in the same position — to advocate on behalf of the airline interests in government and regulate such interests, but then to also police the regulations and ensure airlines do what they agree and say they will do. It’s a role with an inherent conflict of interest which causes all sorts of problems.
If Congress wants to fix the FDA, the only way to do so is to break it into two distinct agencies, one for approval of new drugs, and one for policing of the drug regulations and followup on longer-term drug safety and efficacy.
It’s a painful pill to swallow, but it’s not going to get any easier the longer we wait.
Read the full article: Drug Makers Near Old Goal: A Legal Shield
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The FDA and Its Damaging Lack of Citizen Protection
The Food and Drug Administration originated in its primitive form several decades ago to ensure the health and safety of the citizens of the United States. However, their focus seems to have changed the past few decades, as they appear to have formed a pathological alliance with the pharmaceutical industry. An example is the large amounts of money the industry gives the FDA for various reasons- amounts so large that this accounts, according to some, for about half of the FDA’s income, upon information and belief. An example of funds received is due to the prescription drug user fee act, which began in 1992. Basically, the drug industry has been authorized and required to pay the FDA for faster approval of their pending medications. Results of this relationship between the drug industry and the FDA, one could posit, could be a contributing factor the progressive and recent approval of unsafe drugs and lack of regulation and monitoring of the pharmaceutical industry that the FDA is obligated to perform. Yet the FDA continues to validate what has been posited through their support from the drug industry, in ways that seem reciprocal, and as a consequence, have possibly neglected the health of the public as best as they should.
The presumed intimacy between these two organizations does in fact seem to continue to worsen. For example, and recently, a new proposal by the FDA has been introduced that would allow the pharmaceutical industry’s drug sales reps to discuss their products with prescribers off-label, which means that the FDA may allow and accept the industry with their approval to possibly creating harm to patients with this proposal due to uncertainty associated with unapproved uses of a drug promoted in this way. Yet the FDA claims that this proposal would enhance the education and knowledge of the prescriber by the pharmaceutical representative, and this is rather delusional, to say the least.
A prescriber, upon their own discretion, can in fact prescribe a drug off-label, but historically, however, representatives from the pharmaceutical industry have been prohibited from suggesting this type of activity. In fact, it is a federal offense for such reps to speak off-label about the drugs they promote, and more pharmaceutical companies are being penalized for this behavior in the past in the form of monetary settlements with the Department of Justice. The drug companies that have allowed such criminal offenses, through vicarious liability at times, perhaps, and rarely admit guilt as part of such settlements.
This FDA protocol described and proposed is called, “Good Reprint Practicesâ€, would require pharmaceutical sales representatives to use what may not truly exist, which is truthful and authentic clinical trials when and if they do speak off-label to prescribers. This in itself lacks etiology for such discussions by drug reps, as many clinical trials may be flawed due to the trials being possibly manipulated by the pharmaceutical companies of the meds involved in such trials, such as by a third party. Additional trial deception involves ghostwriting and invalid authors of such trials, and this is one of many concerns of this FDA protocol. These facts can be validated and have been discovered by others, so it appears the FDA did not take this into consideration.
Furthermore, this proposal is flawed in that most pharmaceutical reps lack clinical training and the ability for most drug representatives to analyze the unique statistical data regarding this issue with accuracy and meaning is unlikely, for the most part, I surmise. Remember that most drug reps have no medical or clinical training in any objective way, and, in my experience, have no interest in such training. So this seems to further complicate the idea of this off-label concept due to the ignorance of the reps of the complexities of these once reliable and dependable methods of proof. In addition, the relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for reps to embellish statements to prescribers for their own benefit in regards to their promoted meds. So, our previous safety association, the FDA, appears to be evolving into a possibly harmful association by suggesting such practices as this with deliberate intent and reckless disregard for public health, so it seems. Yet this situation of the FDA proposal mentioned appears to be of most benefit for the drug companies. It’s unbelievable this proposal ever came into existence, with the delusional fallacy that it would be of benefit to patient health, most likely. Furthermore, this may complicate existing patient medication errors, such as in the elderly or dosing for children, complicated by the fact that many are unable to understand label instructions on their med. So there are enough problems with prescribing, and adding this FDA proposal would just make the situation worse. We as citizens are no longer the concern of the FDA, one could conclude.
However, there is freedom of speech, but in the amendment may be restrictions in regards to public health, as speech should be accurate and objective. Perhaps another alternative would be to have clinically trained people discuss such issues with prescribers, instead of the drug reps, who, unlike those academically enriched, have the objective of increasing the market share of their promoted meds with no regard to the science behind these meds, in large part. Because historically, medications have in fact proven to be beneficial for other disease states other than what a certain med was initially indicated for upon approval. Regardless, awareness needs to happen by the citizens involving tactics that are possibly deceptive such as this and many more activities by the pharmaceutical industry that one could argue are in fact somewhat covert and tacit. As citizens, we have the right to insist of the pharmaceutical company to maintain focus on the interest of others besides themselves, which could be the case now with the FDA. And the health of the public is that interests what I believe we as citizens demand, and should be enforced than it appears to be presently.
“As far as we can discern, the sole purpose of existence is to kindle a light in the darkness of being.â€
—- Carl Jung
Dan Abshear