Pharma Reform

Pharmaceutical industry marketing and sales are often blamed for promoting  “off label” prescribing and have been highlighted in prescription drug fraud and product liability cases.

If the healthcare market, industry critics, regulatory agencies, and patients are looking for a way to control and reduce the influence of pharmaceutical company advertising and promotion on prescription drug choice, they should step up and take responsibility for the decisions they are making.  Don’t blame the drug companies for prescribing and reimbursement choices being made by the healthcare market.

Nobody is forcing physicians to prescribe these drugs.  Nobody is forcing insurance companies or the government to reimburse prescriptions written for “off-label” uses.  Nobody is forcing patients to take drugs for unapproved uses or to take drugs that might result in side effects or adverse reactions.  These are all conscious choices.

Information about the appropriate use of prescription drugs and the known potential risks associated with taking these drugs is readily available in the prescribing information (FDA approved label claims or package insert) for each drug.

One would think that prescribing decisions would be based on careful evaluation and assessment by the healthcare market, physicians, and patients and not driven by the influences of pharmaceutical company marketing and sales activities.  How irresponsible is it for physicians, government agencies, or insurance companies to accuse drug company advertising and promotion for determining their prescribing practices or reimbursement policy rationale?  It is also not credible to suggest the government (including state agencies) and insurance companies are being duped by drug companies and are blindly reimbursing for drugs prescribed for “off-label” uses.

So how should this be working?  (I am not trying to be a lawyer here, just proposing how it should be working)

• When a physician and a patient decide to use a product, it should be implicitly acknowledged that they are aware of and understand the information in the product prescribing information (FDA approved label claims and safety information).  If the patient does not understand the information in the product label or the implications of the wording in the product label, it is the physician’s responsibility to help them understand the potential risks and benefits.
• The patient has a choice to take the drug or not based on the information they receive from the physician (and they can read the product prescribing information themselves, if they want to).  By deciding to take the drug, patients acknowledge they are aware of the potential for side effects and adverse reactions and accept these risks (shouldn’t be able to come back and sue the pharmaceutical company for something that is in the package insert).  They have made an informed choice to accept the risks.
• Pharmacists, before dispensing a prescription, should make sure patients understand how to take their medications and the potential side effects, adverse reactions, and food or drug interactions.  Dispensing pharmacists should be accountable for making sure patients understand the risks.
• Physicians should prescribe products only for the FDA approved label claim indications.  Physicians who prescribe and patients who decide to take a drug for an “off-label” indication or use should assume the product liability for how the patient responds to the drug (lack of efficacy or any resulting side effects and adverse reactions). They have made a conscious informed decision and choice to prescribe the product for a use for which the manufacturer has not obtained sufficient evidence of safety or efficacy (FDA approval).
• Government programs (e.g., CMS), private insurance companies, healthcare provider plans (including state government programs), and pharmacy benefits managers should reimburse only for FDA approved label claim indications.  By providing reimbursement for “off-label” uses, I believe they are complicit in the promotion of “off-label” use of prescription drugs.  The lack of reimbursement makes the promotion of products for “off-label” uses much less attractive for drug companies.
• Insurers (private or public) who provide reimbursement for off-label uses of a product should assume all product liability for its “off-label” use, including lack of efficacy or any resulting side effects or adverse reactions. (can’t come back and sue the pharmaceutical company)
• Insurers (private or public) who agree to reimburse for “off-label” use of a product should not be able to sue for false claims or fraud related to that “off-label” use.  The insurer knows the physician has made a conscious decision to prescribe the product for an “off-label” use, the patient has been informed of this decision and how it was reached (discussion with the physician), and the reimbursing insurer has the prescribing information against which to evaluate their decision.  By providing reimbursement, the insurer acknowledges agreement with these decisions and should accept the potential liabilities.

If the healthcare market, insurers, physicians, and patients don’t want to be influenced by drug company advertising and promotion, they can simply take responsibility for the drug treatment choices and reimbursement decisions they make.  The ready availability of FDA approved prescribing information leaves little excuse to be unduly or inappropriately influenced by drug company marketing and sales activities.  In fact, isn’t it embarrassing to admit that prescribing and reimbursement decisions are based more on pharmaceutical company marketing and sales than medical information and clinical judgment.

So quit blaming drug companies for prescribing choices and reimbursement decisions.  mike@pharmareform.com