Posted by: Paul A. Forsyth | May 16, 2014

Patent Life and Off-Label Scripts for Prescription Drugs

From an NPR story I heard earlier this week, about physicians writing off-label prescriptions — i.e., a prescription for a drug that has been approved for some other use but has not been approved by the FDA to treat the specific condition of the patient seeking the prescription (emphasis added):

There are many reasons why a doctor will write an off-label prescription. It could be a last resort. It could be a cancer drug that shows promise when all other options have failed. Or it could be anecdotal evidence from other doctors who say the medication works for certain conditions. Dr. Caleb Alexander, who co-directs the Johns Hopkins Center for Drug Safety and Effectiveness, says patients may not even know that prescriptions they get are off label. “For example, the use of anti-seizure drugs to treat depression or neuropathic pain, or the use of certain cancer drugs to treat macular degeneration, ” he says.

Off-label drug prescribing is neither bad nor good per se, says Dr. Randall Stafford, an epidemiologist with the Stanford Prevention Research Center. There may be studies and research showing the drugs safe and effective to treat that condition. But there may not be. In most cases, Stafford says, the evidence just doesn’t exist.

So why aren’t these medications FDA approved for those uses? It boils down to money.

It can cost drug companies hundreds of millions of dollars to do the research and perform the clinical trials necessary to meet the rigorous demands of FDA approval. They’ve done that once for the initial approval, and many are not willing to do it again for a secondary use.

Alexander says many companies view it as simply not worth it, especially if there are only a few years left in a drug’s patent life. Once the drug goes generic, he says, it’s not as profitable.


Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

Categories

%d bloggers like this: