Off-label free speech?

October 4th, 2009

In an effort to take a break from cleaning, I’ve been reading health news again. Ages and ages ago, I had an internship with a pharmaceutical company (in their QA area) so issues regarding prescription drug use can be quite interesting to me.

It seems that the makers of Botox are suing the FDA over restrictions on discussing unapproved uses for their products (aka off-label use) with doctors. (story here) They say their 1st amendment rights are being infringed upon. Now why is this even an issue? At present, drug companies have to submit documentation to the FDA proving that their drug is essentially safe and effective for a specific condition. If the FDA agrees, they are allowed to put (on the label) that their drug is approved for use in XYZ condition. Makes sense, right? Checks and balances and a stamp of approval. Well, this is an issue because at the same time the company is trying to figure out what other conditions can be treated using their drug. Maybe there isn’t enough evidence (as determined by the FDA) to say that this drug is effective and should be approved for use for a new condition (we certainly need to be careful about what drugs are approved, for example the COX-2 inhibitor litigation). Now we get to the key issue here. Even if a drug is not approved for use in a condition, Doctors are still allowed to prescribe it for said unapproved use. However, drug companies are not allowed to influence Doctors to do so. They are not allowed to recommend off label uses of their drugs.

And I agree that they shouldn’t. And this regulation is not, in my opinion, impugning on their first amendment rights.

Why? What the Executive VP of Allergan said is at the heart of it “Allowing physicians to use drugs off-label, but at the same time prohibiting drug companies from proactively sharing relevant and truthful information with physicians regarding the risks and benefits and techniques for off-label uses does not serve the public health or patient care…” The problem of it all is that the FDA, which regulates your industry, does not agree that you are telling the “truth”. You have not proven sufficiently (yet) that your drug really is effective in treating an off-label condition. If you had, it wouldn’t be off-label! If a Doctor and their patient want to use what is essentially an experimental treatment for a condition, that should be allowed. However, you, as the maker of that drug, do not get to tell them that your product is safe and effective when that is not presently the truth. The burden of prescribing an experimental treatment is on the doctor and they should rely on many sources (not just one with a vested interest in selling their product) before making that decision with their patient.

Now… off to do laundry