A recent Wall Street Journal article reported this:“The U.S. Food and Drug Administration wants to allow drug companies to give doctors information about unapproved uses of prescription drugs.”1 Physicians, and perhaps dermatologists in particular, are very familiar with “off-label” medication use. But while this issue is already drawing criticism from lawmakers, it needs to be examined further by the medical community.
OFF-LABEL PRESCRIBING
There is ample evidence that physicians commonly prescribe medications offlabel. Radley and colleagues examined off-label prescribing habits among officebased physicians for 160 commonly prescribed drugs.2 The study reported 150 million off-label mentions (21% overall use) among the sampled medications.The authors also reported that most of the off-label mentions “had little or no scientific support,” that the majority (73%) lacked evidence of clinical efficacy, and only 27% were supported by strong scientific evidence. The authors did note that some off-label medication use represented “a logical extension of the FDA-approved indication,” such as use of asthma inhalers for COPD.
But some off-label uses were distinctly different from their FDA indications. For example, gabapentin, labeled for use as an anticonvulsant, is widely used for chronic nonspecific pain.
NOT THE SAME AS OFF-LABEL PRODUCT MARKETING
While it is clear that physicians commonly prescribe medications off-label, it is not clear how allowing pharmaceutical companies to market medications off-label is going to help me treat my patients. Like many dermatologists, I use medications off-label on a daily basis. The use of these I learned from my mentors, reading medical journals, and attending medical conferences. Many uses of medications off-label are highly efficacious; some of these are based on published reports and someare based purely on experience. But will listening to a sales pitch from pharma about a case report published in an obscure journal really be helpful?
FORMAL EVIDENCE-GATHERING BENEFIT
This brings us to my next point: What level of evidence will be required to use a study for marketing? A doubleblinded study or a case series of 100 patients does not represent the same level of evidence as a case series of three patients or a case report.
However, I do think there may be a silver lining here: Perhaps allowing off-label marketing will encourage the pharmaceutical industry to sponsor more clinical trials, which have the highest level of evidence.This, in turn, may show that a medication is safe and effective and provide financial support to academic institutions and those dermatologists who participate in clinical research at the same time.
FDA MOTIVES
Still, I find it odd that the FDA would consider allowing off-label marketing at this time — especially since the FDA and the pharmaceutical industry have been under so much public scrutiny. Is it possible that the FDA is simply attempting to pass the responsibility of monitoring safety and efficacy of medications to physicians and the pharmaceutical industry? I am also not sure if this will help my decision-making process concerning treatment options for my patients. However, if the FDA does decide to go through with this plan, I certainly hope that only studies with the highest levels of evidence are permitted to be used for off-label marketing.
A recent Wall Street Journal article reported this:“The U.S. Food and Drug Administration wants to allow drug companies to give doctors information about unapproved uses of prescription drugs.”1 Physicians, and perhaps dermatologists in particular, are very familiar with “off-label” medication use. But while this issue is already drawing criticism from lawmakers, it needs to be examined further by the medical community.
OFF-LABEL PRESCRIBING
There is ample evidence that physicians commonly prescribe medications offlabel. Radley and colleagues examined off-label prescribing habits among officebased physicians for 160 commonly prescribed drugs.2 The study reported 150 million off-label mentions (21% overall use) among the sampled medications.The authors also reported that most of the off-label mentions “had little or no scientific support,” that the majority (73%) lacked evidence of clinical efficacy, and only 27% were supported by strong scientific evidence. The authors did note that some off-label medication use represented “a logical extension of the FDA-approved indication,” such as use of asthma inhalers for COPD.
But some off-label uses were distinctly different from their FDA indications. For example, gabapentin, labeled for use as an anticonvulsant, is widely used for chronic nonspecific pain.
NOT THE SAME AS OFF-LABEL PRODUCT MARKETING
While it is clear that physicians commonly prescribe medications off-label, it is not clear how allowing pharmaceutical companies to market medications off-label is going to help me treat my patients. Like many dermatologists, I use medications off-label on a daily basis. The use of these I learned from my mentors, reading medical journals, and attending medical conferences. Many uses of medications off-label are highly efficacious; some of these are based on published reports and someare based purely on experience. But will listening to a sales pitch from pharma about a case report published in an obscure journal really be helpful?
FORMAL EVIDENCE-GATHERING BENEFIT
This brings us to my next point: What level of evidence will be required to use a study for marketing? A doubleblinded study or a case series of 100 patients does not represent the same level of evidence as a case series of three patients or a case report.
However, I do think there may be a silver lining here: Perhaps allowing off-label marketing will encourage the pharmaceutical industry to sponsor more clinical trials, which have the highest level of evidence.This, in turn, may show that a medication is safe and effective and provide financial support to academic institutions and those dermatologists who participate in clinical research at the same time.
FDA MOTIVES
Still, I find it odd that the FDA would consider allowing off-label marketing at this time — especially since the FDA and the pharmaceutical industry have been under so much public scrutiny. Is it possible that the FDA is simply attempting to pass the responsibility of monitoring safety and efficacy of medications to physicians and the pharmaceutical industry? I am also not sure if this will help my decision-making process concerning treatment options for my patients. However, if the FDA does decide to go through with this plan, I certainly hope that only studies with the highest levels of evidence are permitted to be used for off-label marketing.
A recent Wall Street Journal article reported this:“The U.S. Food and Drug Administration wants to allow drug companies to give doctors information about unapproved uses of prescription drugs.”1 Physicians, and perhaps dermatologists in particular, are very familiar with “off-label” medication use. But while this issue is already drawing criticism from lawmakers, it needs to be examined further by the medical community.
OFF-LABEL PRESCRIBING
There is ample evidence that physicians commonly prescribe medications offlabel. Radley and colleagues examined off-label prescribing habits among officebased physicians for 160 commonly prescribed drugs.2 The study reported 150 million off-label mentions (21% overall use) among the sampled medications.The authors also reported that most of the off-label mentions “had little or no scientific support,” that the majority (73%) lacked evidence of clinical efficacy, and only 27% were supported by strong scientific evidence. The authors did note that some off-label medication use represented “a logical extension of the FDA-approved indication,” such as use of asthma inhalers for COPD.
But some off-label uses were distinctly different from their FDA indications. For example, gabapentin, labeled for use as an anticonvulsant, is widely used for chronic nonspecific pain.
NOT THE SAME AS OFF-LABEL PRODUCT MARKETING
While it is clear that physicians commonly prescribe medications off-label, it is not clear how allowing pharmaceutical companies to market medications off-label is going to help me treat my patients. Like many dermatologists, I use medications off-label on a daily basis. The use of these I learned from my mentors, reading medical journals, and attending medical conferences. Many uses of medications off-label are highly efficacious; some of these are based on published reports and someare based purely on experience. But will listening to a sales pitch from pharma about a case report published in an obscure journal really be helpful?
FORMAL EVIDENCE-GATHERING BENEFIT
This brings us to my next point: What level of evidence will be required to use a study for marketing? A doubleblinded study or a case series of 100 patients does not represent the same level of evidence as a case series of three patients or a case report.
However, I do think there may be a silver lining here: Perhaps allowing off-label marketing will encourage the pharmaceutical industry to sponsor more clinical trials, which have the highest level of evidence.This, in turn, may show that a medication is safe and effective and provide financial support to academic institutions and those dermatologists who participate in clinical research at the same time.
FDA MOTIVES
Still, I find it odd that the FDA would consider allowing off-label marketing at this time — especially since the FDA and the pharmaceutical industry have been under so much public scrutiny. Is it possible that the FDA is simply attempting to pass the responsibility of monitoring safety and efficacy of medications to physicians and the pharmaceutical industry? I am also not sure if this will help my decision-making process concerning treatment options for my patients. However, if the FDA does decide to go through with this plan, I certainly hope that only studies with the highest levels of evidence are permitted to be used for off-label marketing.
