Doctors have always been able to prescribe whatever drug they want, for whatever they want. However, drug companies have only been allowed to advertise and market drugs that have been FDA-approved for specific uses or disorders. That means that generally an antidepressant drug can only be marketed and advertised for depression. If a company wants to market and advertise its drug for other uses, it has to go back to the U.S. Food and Drug Administration (FDA) and file additional applications, with a wealth of supporting research to support those uses.
Unless the research is strong and the market is potentially lucrative, many pharmaceutical companies choose to limit the amount of additional uses they seek FDA approval for.
Any use of a drug that hasn’t gained FDA approval is considered “off-label,” in that it is a use not on the drug’s label.
So how do doctors know what drugs to prescribe off-label for what conditions? Well, they might hear about it at a conference (continuing medical education, or CME, which as Dr. Carlat blogs about is often indirectly funded or sponsored by drug companies), or read about it in a favorite medical journal.
But drug companies have long viewed such a method as fairly unreliable.
So what if the FDA told pharmaceutical companies they could help educate doctors about these off-label uses?
The Wall Street Journal has the story, Boost for Off-Label Drug Use:
The Food and Drug Administration wants to allow drug companies to give doctors information about unapproved uses of prescription drugs, a controversial move that is already drawing objections from Capitol Hill. […]
The regulator is stepping into a high-stakes business issue, because off-label uses of prescription drugs are a mainstay of the industry — an estimated 21% of drug use overall, according to a 2006 analysis published in the Archives of Internal Medicine.
Ostensibly the FDA wants to publish such guidelines to help regulate a murky area of drug marketing and address this common use of prescriptions.
A fifth of all drugs are already being prescribed off-label, and amongst psychiatric drugs, it rises to 31% (Radley, et. al. 2006) — one out of three psychiatric drugs are being prescribed for a use not approved by the FDA. But this isn’t new news, and I suspect the actual number is even higher.
The real problem with off-label use is that it has less evidence, and lower quality evidence, to support prescribing the drug. In Radley et. al. (2006), they found:
No more than 30% of the off-label practices we observed were supported by strong scientific evidence.
That means in 70% of the data they analyzed — the vast majority — doctors were writing prescriptions for off-label use of drugs with minimal empirical evidence to support that prescription.
Which is absolutely fine, because it is a physician’s prerogative to use their own, individual clinical judgment to write such prescriptions.
But what’s going to happen when we let drug companies, who have a strong financial interest and inherent bias, to market their drugs for any and all off-label uses, using minimal evidence (e.g., a single published case study, for instance)?
We think it’s inappropriate for the FDA to allow drug companies to promote these additional off-label uses of drugs directly to physicians, because (a) such use has far less rigorous clinical data to support such widespread promotion; (b) the potential for abuse of this marketing to doctors is simply too high; and (c) pharmaceutical companies’ marketing departments have shown an uneven history of acting in the best interests of patient safety or a drug’s true effectiveness. If the FDA wants to clear up this murky area of their regulations, they should feel free to do so, but not by opening up even more marketing opportunities for companies.
Want to read more? We suggest Merrill Goozner’s FDA Proposes Lack-of-Evidence-Based Medicine Policy.
Reference:
Radley DC, Finkelstein SN, Stafford RS. (2006). Off-label prescribing among office-based physicians. Arch Intern Med., 166(9), 1021-6.
6 comments
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
It’s true. FDA should take a tougher position to handle this issue. Drug companies are doing business. It’s not surprise that they will only put the money first. Off-label use provides a bigger market and huge profit. That’s why companies aggressively promote off-label use of their products. FDA has the responsibility to protect public health and hold drug companies a little bit back(they already go too far). What are they doing now is to give up some responsibility for public.