Category: Government

Free Speech and Off-Label Drug Use

When pharmaceutical representatives talk to physicians and others about their products, they are only allowed to talk about indications (reasons) to use the product as approved by the Food and Drug Administration. Doctors are free to prescribe for other reasons, and often do so for good reasons.  Drug companies may pay dearly if they break the rules. Pfizer paid 2.3 billion due to promoting Bextra for off-label use, for example.

This rule was put into effect decades ago to protect consumers. Since then there have been a number of examples of products promoted for things that in retrospect didn’t work as advertized. If you’re old enough, you’ve probably heard the term snake oil.

According to the Wall Street Journal there are now several court cases that may change these rules. In June the U.S. Supreme Court struck down a Vermont law and cited the First Amendment in a case involving pharmacies sharing data with pharmaceutical companies to help them market their drugs to doctors. That has opened the door for the companies to now claim the same free speech rights to market drugs off-label.

If the companies gain this ability, it would be bad for patients. Basically they could say whatever they want. Besides talking about off label use where there is legitimate reasons to use their product, they could claim anything they wanted to say. “Our drug is more effective than our competitor,” even if it’s not. “Our drug is perfectly safe,” even if it’s not. “Our drug will make you lose weight, increase your IQ, improve your looks, and make you live 10 years longer, “even if it won’t, but if you believe it, let me tell you about a bridge for sale.

I learn about a lot of new drugs because the sales reps come to my office to tell me about their product. As it is, I listen to them skeptically and off challenge what they say. Although they are restricted on what they can say, they can choose what information to emphasize and how to make their product look good without actually lying. If they can promote off label, I won’t know what to believe. Then my strategy might be to stop seeing reps.

How Primary Care Docs Became Assistant Shoe Salesmen

Nurse practitioners, physician assistants, pharmacists and naturopaths have gained the right to prescribe medications traditionally only done by a physician. But the Medicare Therapeutic Shoe Bill requires that the physician managing the diabetic condition certify the need for footwear and inserts.

So although the podiatrist truly has the expertise in this arena, it falls on the patient’s primary care physician or endocrinologist to do the paperwork. Congress might have been concerned that because podiatrists profit from selling inserts or shoes, that someone else should determine whether it’s really needed. In fact, though, us primary care docs are overworked and don’t have much time to deal with such paperwork. If we deny that the patient needs it, especially after their podiatrist already told them they do, the patients get mad at us.

I think the best way to minimize fraud would be to have patients pay a portion of the cost, say 25%. That way they are less likely to get a shoe or insert unless they feel they really need it. Actually Medicare pays 80% of the allowable amount so patients pay up to 20% if they don’t have secondary insurance. Since most patients are going to buy a pair of shoes in any case, I think they should pay what a similar non-medical shoe would cost, and Medicare would pick up the difference. That way there would be no financial incentive for patients to get shoes they don’t really need, and doctors could stop being the watchdog.

At the very least, Congress should allow nurse practitioners and physician assistants to do the paperwork.