drug promotion

Off-label Drug Use: Fact vs. Fiction

Posted by cdavenport on Friday Aug 17, 2012 Under Drug Promotion, Drug Safety, FDA

The authors – CM Wittich, CM Burkle, and WL Lanier – offer a concise review of the topic of off-label drug use including its definition, prevalence, and implications for drug safety.   The article format addresses 10 common questions and their answers about off-label drug use.  The breadth of application, its acceptance, and the liabilities of off-label use are explored.  A history of FDA regulations surrounding the practice is presented, which helps to put its evolution into proper perspective.  Off-label use, which occurs in every medical specialty, is more common in patient populations not likely to be included in clinical trials (e.g., pediatric, pregnant, or psychiatric patients).  Once a medication is marketed, the FDA does not limit or control how the medication is prescribed by physicians. The pros and cons of the distribution of information regarding the off-label use of medications by pharmaceutical companies, the use of informed consent, and the liability of prescribing physicians are discussed.

SourceMayo Clinic Proceedings  – pdf of full article.

Tags : , , , , , , , , , , , , | add comments

Four proposals that address drug advertising and marketing issues, which have not been widely discussed, may be incorporated into the final health care reform bill.

1)  Of most concern to the pharmaceutical industry is a proposal to eliminate the tax deduction for drug advertising.  Direct-to-consumer (DTC) advertising is a prime target due to concern that DTC ads do not present an accurate picture of drug risks and benefits and that they drive use of new drugs before their safety is fully known.

2)  Health care reform bills in both the House and the Senate contain transparency provisions, akin to those in the Physicians Payments Sunshine Act of 2009, which propose for the disclosure of drug and device company payments to doctors to be federally mandated.

3)  Section 138 of the health care reform bill  bans the commercial use of “prescription information containing patient identifiable and prescriber identifiable data.”  If passed, Section 138 would end drug representatives’  current practice of tailoring their sales messages to each doctor’s prescribing history, which can put more pressure on doctors to prescribe newer, more expensive medications.

4)  The health care reform bill would authorize the FDA to evaluate whether use of a “drug facts box” format on drug labels – to more clearly present a drug’s benefits and risks – would improve health care decision making.  This  bill would also allow the FDA to set standards for comparative clinical effectiveness information to be included in drug labeling and advertising.

Source:  Health Reform Watch, 2 October 2009.

Tags : , , , , , | add comments

Allergan, the maker of Botox, is suing the federal goverment by asserting that marketing restrictions prevent the company from communicating practical medical information — like patient selection criteria or optimal dosing patterns — to doctors that could reduce the risk of serious health problems arising from off-label uses of the drug.  Douglas S. Ingram, the executive vice president of Allergan, asserts that by allowing off-label drug use but by “prohibiting drug companies from proactively sharing relevant and truthful information with physicians regarding the risks, benefits, and techniques for off-label uses, does not serve the public health or patient care.”   Jeffrey N. Gibbs, a Washington lawyer specializing in food and drug law, asserts this case to be “the broadest attack on the constitutionality of FDA restrictions on speech brought by an individual drug company.  It’s a precedent-setting case.”   Although other pharmaceutical companies have not joined the lawsuit, the outcome will be closely monitored.  An article in the HealthLawProf blog attempts to place this issue into historical context.    It is speculated that Allergan may be utilizing the case to gain leverage with the Agency in negotiating the legal distribution of information on the prevalent off-label uses of drugs, like Botox.  New York Times, 2 October 2009.

What are your thoughts on how best can the pharmaceutical industry distribute safety information on the off-label use of its drugs?

Tags : , , , , | add comments