Suit Filed by Allergan Could be Precedent Setting

By Rachel Howell Stockton

A lawsuit was filed two days ago by the company that manufactures Botox.  Allergan is challenging the FDA’s regulations regarding drug marketing.  At the very least, the case promises to garner attention from just about every pharmaceutical company in the country.

The issue at stake here is off label usage.  As it stands, drug companies are not allowed to market off label drug possibilities to doctors or consumers.  The reason for this, according to the FDA, is that off label uses for drugs do not conform to the standards that the FDA has established before a drug can be marketed for its primary, approved usage.

Confused?  Here’s what’s at stake in this case:  Allergan believes that they have the right to market to doctors who want to use Botox for other things besides what the FDA approved it for.  Once standards that are set by the FDA are met, the company applies for approval.  They may not put the product on the market until they receive formal approval from the FDA.

Botox has been approved to use as an anti-wrinkle procedure, but it’s also been approved for 4 other uses, including uncontrollable eye-blinking and crossed eyes.  While the drug has been approved for only 5 uses in this country, the total number of indications (or off label uses) has reached 21 worldwide.  Some doctors use it to treat migraine headaches and spasticity. 

Physicians have the freedom to decide whether or not they want to prescribe a drug for an off label use.  Allergan believes that they should be able to communicate recommended criteria and dosages for such usage; after all, if any one knows a drug’s advantages and limitations, it’s the company that manufactured it.

This is a precedent setting case, as Botox’s unique position has made it possible for some lessening of FDA regulations.  However, critics say that the FDA would be rendered “useless” if drug companies are able to go full throttle with their advertising.