The Public Policy
FDA’s Bad Medicine
Next victim, off-label prescriptions? That appears to be the intention of Henry Waxman and his man at the FDA.
President Barack Obama promised to shake up the Food and Drug Administration, so it’s no surprise that his new FDA leadership team has made bold moves. Deputy Commissioner Joshua Sharfstein, who led the agency until Commissioner Margaret Hamburg was approved by the Senate on May 18, announced his presence with authority.
In his first two months, Sharfstein’s FDA has threatened to regulate Cheerios as a drug because its label says it can help lower your cholesterol and proposed action against drug companies because Google Internet searches for their products don’t show enough safety information.
Sharfstein was chosen to lead the FDA’s drug enforcement efforts in part due to his connections as a former staff member for Rep. Henry Waxman (D-Cal.), chairman of the congressional committee that oversees the FDA, and one of the pharmaceutical industry’s biggest critics.
Since he’s already shown a desire to clamp down on even minor infractions, drug makers and the medical community are holding their breath over what Sharfstein may do next. One likely move is a crack down on so-called “off label” prescribing of drugs, which has been one of Waxman’s high priorities for years.
When the FDA approves new drugs or medical devices, they are approved to treat specific conditions in particular populations, which are identified on the products’ labels. But once they are on the market, doctors are free to prescribe drugs and devices for any safe and effective use, including ones not indicated on the label.
Getting FDA approval to add another use to a drug’s label is time consuming and very expensive, even after rigorous clinical testing shows the new use to be safe and effective. But physicians read medical journals. And if they find, for example, that a certain liver cancer drug is effective in treating kidney cancer, or that an antidepressant approved for adults also works for teenagers, these other uses tend to be adopted.
This practice of off-label prescribing is widespread, and is common in every field of medicine. By some estimates, as many as 60 percent of all prescriptions written are for off-label uses. The American Medical Association has repeatedly studied the practice and concluded that “physicians have the training and experience to determine what is the best or preferred method of treatment for their patients.”
Accordingly, the AMA says off-label prescribing should often be considered “reasonable and necessary medical care, irrespective of labeling.” Indeed, physicians may even be subject to malpractice liability if they do not use drugs and devices for off-label indications when doing so constitutes the medically recognized standard of care.
Still, certain members of Congress and bureaucrats in the FDA think doctors should prescribe nothing without the express consent of the federal government. The FDA, for example, proposed regulating off-label drug use in 1972, but gave this up after vigorous objection from the medical community. Beginning in the 1990s, however, FDA began restricting the ability of pharmaceutical manufacturers to give physicians peer-reviewed journal articles and other information about off-label uses of their drugs.
FDA treats any drug information distributed by manufacturers, no matter what its form, as part of the product label. So as far as the agency is concerned, mailing out reprints of peer-reviewed journal articles describing an off-label use makes the drug or device “mis-branded.”
Physicians try to keep abreast of new research findings, but they can’t read every issue of the hundreds of medical journals published in this country. So drug makers have long distributed journal reprints in an effort to promote their products. Regulators regard the practice as grubby commercial marketing, but the distribution of scientific studies allows physicians to be better informed about new developments and enables them to make better treatment recommendations for their patients.
The practice also happens to be protected by the First Amendment. In a series of challenges to FDA’s reprint restrictions, federal courts have held that the policies “restricted considerably more speech than necessary” to ensure the information was truthful and not misleading. FDA may monitor the practice to ensure the information is not biased, but forbidding the practice altogether is unconstitutional.
By 2007, recognizing that the FDA could not ban the dissemination of all information about off-label drug uses, the agency published a guidance document in the waning days of the Bush Administration that explained what procedures drug firms had to follow in order to be within the boundaries of the law.
Rep. Waxman, however, chaffed at even this modest step. He claimed the guidance would promote “potentially dangerous uses” of drugs and would “short-circuit the FDA review and approval process.”
Not only did Waxman criticize allegedly “abusive marketing practices” by the drug industry, he even attacked the integrity of medical journals themselves and the peer-review process, and he insisted that FDA bureaucrats be placed in the position of judging the quality of the scientific literature.
Letter to the Editor View all comments (46) | Leave a comment
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Rebecca| 6.1.09 @ 8:07AM
I didn't realize this was happening. What about the public that treats themselves with OTC medicines, herbs, vitamins? Didn't a young girl die from rubbing too much of the OTC cream for sore muscles on herself? And that was the intended use, rub on sore muscles.
I would hazard to guess the most pressing problem with any drug or treatment is the failure of the patient or individual to follow directions. It isn't just the rare person that quits taking anti biotics until they are gone leading to superinfections.
Until we make a better man, all these utopian laws end up for the most part punishing law abiding persons.
Also, I believe there is a drug company that has two different meds, one for the treatment of macualar degeneration, and one that isn't. Ironically the one that isn't seems to work every bit as good, but is much cheaper. I thought I read the parmaceutical company does not want off label use. It doesn't take a genius to figure out the motivation.
Eric Damon| 6.1.09 @ 8:29AM
Re: Rebecca
What would be the reason you see that manufacturers would want to restrict off label use of their products? It would seem to me that the drug company simply wants to make as much money as possible, so off-label scrips would help the bottom line. If they are avoiding off label scrips it is probably because they are trying to keep the government off their backs and out of their business.
Regulating Cheerios as a medicine! Does it get any more Big Government than that?
CS Lewis| 6.1.09 @ 8:55AM
Real life experience on this topic.
Went to the emergency room 2am in the morning because Reflux attack so painful (pain would not stop) I passed out on the floor at home (hyperventilating). Pain came in waves and would not stop.
Hooked up to IV, blood taken, doctor agreed it was extreme Reflux pain.
Doctor gave me Zofram to stop the pain and after about an hour it stopped completely and I could go home.
The doctor said Zofram is given to cancer patients for pain and they've found that it worked for my type of pain. Remember this if you are ever having a reflux attack.
I knew it was Reflux because it was diagnosed several years ago. After my first attack I have been able at times to stop it by drinking water or with Mylantia - not this time! :(
P. Aaron| 6.1.09 @ 9:03AM
All this from the same people that put us $68 Trillion in debt.
jerryofva| 6.1.09 @ 9:56AM
I would love to see a doctor or patient go to Federal Court to stop the government from interferring in the doctor-patient relationship. Isn't this all covered by the "right to privacy" discovered by Justice Blackman in Roe v Wade?
Galen| 6.1.09 @ 10:01AM
As many people,Waxman is jealous and wants to
play doctor. Many people are spared suffering by
off label drug use.
Barb| 6.1.09 @ 10:02AM
C. S. Lewis writes about Zofram..and it's off label use. I think it's ZofraN, and it's an anti nausea drug originally developed to treat the side effects of chemo. I've also been treated with it many years prior to actually having cancer and chemo, and it was very effective. Off label maybe, effective yes, as a patient with a long a varied medical history and over 100 hospitalizations, who should have been dead long ago, I can say that I have truly been helped many times by "off label" use of drugs. My physician knows much more than my Representative! They should let the doctors practice medicine. All this talk of government intervention in health care scares the Heck out of me.
CS Lewis| 6.1.09 @ 10:13AM
I was there (hospital) from 2am to 4am, my head hurting from crashing to the floor so I got the word a little wrong. Thanks for the correction. I probally heard it wrong.
The last thing I remember was lurching from kitchen counter to table and then I woke up on the floor . Hit my hip, arms, shoulders and back of my head. Head still hurts probally a small concussion. First time in my life I ever passed out. Hyperventalating is something else.
I had waves of pain in my stomach and chest, nausea, I was white as a ghost. My doctor said his father has a heart attack with such an attack.
The first time you experience this you think you are having a heart attack - that's what sent me to the hospital the first time. :(
CS Lewis| 6.1.09 @ 10:20AM
The doctor was going to give me two tablets of ZofraN to take home but they couldn't find any (small hospital) so they gave me two Promethazine instead, said it would work. Didn't need it but keeping them handy!
And Barb... I wish you many more years ... God Bless. :)
Old Texican| 6.1.09 @ 11:10AM
The communists are already beginning to "ration" health-care it seems.
HOOOOOOOboy! Can't you just love a bureacrat deciding EVERYTHING under nationalized health care?
(especially if you vote Republican?)
Frightening indeed.
ccc| 6.1.09 @ 1:56PM
Is the off label use explained to patients? Do they know that they are effectively being used as experimental guinie pigs?
Big Leo| 6.1.09 @ 2:08PM
My doctor prescribed an anti-arthritis drug to treat another illness, and it worked great. He told me that it was off label, so I was properly informed, and the drug had a great track record in treating the other condition. Why does the government feel compelled to jiggle my doctor's elbow while he's trying to treat me?
Richard Baker| 6.1.09 @ 2:40PM
Remember DMSO, hope I'm correct on the acronym? It was a horse liniment that was wildly popular for arthritics. Physicians and their patients are going to find a way to use what works, regardless of what some government busybody does. Whether it be DMSO or some other substance used for a different treatment, the experimentation/trial will still occur, regardless. Remember Laetrile for terminal cancer patients? Steve McQueen tried it at the end of his life. Give someone suffering an option and they'll try it. Everyone goes into this with their eyes open, especially with the Internet as a source of information.
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Country Doc| 6.1.09 @ 6:54PM
Restricting off label use would be another nail in the coffin for medical professionals who already spend too much time ordering unnecessary tests to cover their hind ends from malpractice or time on the phone with insurances trying to get prior authorizations for medications that the insurances refuse to cover. I can think of at least ten or so meds I used for patients today that were for off label use. Brilliant idea. Let's take away my ability to give someone in pain gabapentin (approved for seizures but now only used for neuropathic pain) and instead force me to use controlled substances like hydrocodone instead. Great move. I hope we run the majority of these idiots out in 2010.
DaveS| 6.1.09 @ 8:16PM
Somebody must be sitting around looking for a stimulus that suggests he regulate something. Another clown in circus administration.
Small Town Surgeon| 6.1.09 @ 8:34PM
Off label is not experimental. It's something that was discovered by serendipity, and by the time it's being called "off label" it has gone through experiments to see if it works.
2 Great examples of off label uses:
Zantac as an adjunct to allergy treatment (it's an antihistamine that works mainly on the stomach to reduce acid, but does help with severe allergies like hives).
Erythromycin to aid in gastric motility in gastroparesis (basically a paralized stomach from daibetes or ulcer surgery).
The news story from a day or two ago about the new cancer breakthrough is testing of an off label use of herceptin. It's labeled only for certain cases of breast cancer, but in Europe they were testing it on stomach cancer and it seems to work in selected cases of stomach cancer.
Government probably won't complain about those too much because they are now available as generics, and there is no evil pharmaceutical company making big bucks off of name-brand medications. They probably will complain about us "filthy rich doctors" are probably the ones they are going to come after for using generic meds off label. If the government calls me filthy rich, that makes them the Saudi Royal family.
Bob Robinson| 6.4.09 @ 3:01PM
Just remember with any Drugs there are risks and when you prescribe an Off-Label drug for something it has not been tested for you don't know without proper testing if there could be additional risks that could cause harm.
Like it did to my wife who died because of an Off-Label drug. She even came in complaining of pain the drug was known to cause and the doctor sent her home thinking it was something else.
Richard Baker| 6.4.09 @ 6:00PM
I would guess that the majority of these alternate uses are fairly successful. That some people have bad reactions is because in any process there are always a small percentage of bad outcomes, no matter what. As I said earlier, someone wanting relief will always try this option. Because a small percentage doesn't do well is no reason to lose our minds on this. The liberal mind believes that perfection is possible if we just restrict and criminalize everything yet self-euthenasia is ok. Does that make any sense? Intelligent folks know better. If I had the need, the busybodies can just suck hind tit.
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