Suboxone Maker’s Petition Denied by FDA

Originally Posted 2/23/2013

I’ve written in detail about the bold move by Reckitt-Benckiser, maker of Suboxone, that few people outside the company saw coming.  In brief, the company has been cruising across the Atlantic for the past ten years, fueled by stellar growth of its flagship medication, even as the expiration of the patent on Suboxone loomed ahead (y’know– like an iceberg).

But unlike the Titanic, RB had a secret plan to deal with icebergs.  A couple months ago, the company hired a company that investigates bad drugs to look into its OWN product, Suboxone tabs, and used those findings to tell the FDA that the source of their profits for the past ten years is a BAD DRUG.  In fact, it is SO bad that they insisted on doing the right thing—file a Citizens Petition with the FDA to make sure that NOBODY ever makes that bad drug again.

By coincidence, RB happened to have a DIFFERENT drug with a fresh, new patent expiration date that they promised was much safer than the drug they used to make.  And by coincidence (insert more sarcasm), this all happened a year or so after the patent on the bad drug ran out, so RB was willing to just get rid of the bad drug completely.    Never mind that a bunch of other companies were about to make less-expensive generic forms of Suboxone; RB asked the FDA to protect the American people by banning those awful Suboxone tabs that used to make them so much money.

But on Friday, the FDA essentially told RB ‘thanks for the warning… but we’re cool.’  They denied RB’s request to block the tablets, opening the door to generic manufacturers to consider making less-expensive forms of buprenorphine/naloxone, what RB calls ‘Suboxone.’

RB (stock symbol RBGPF) has been dodging icebergs for ten years.  I’ve wondered over the years how they would navigate through some very treacherous passages.  How did they get everyone to buy into the idea that Suboxone is significantly different than plain, cheap buprenorphine?  How did they get state Medicaid agencies to cover ONLY the branded product, when the generic buprenorphine is clinically identical to Suboxone?  A glance at the price of shares in RB shows that they have been doing it well—at least up to now.

Reckitt-Benckiser Stock Price
Reckitt-Benckiser Stock Price

But the seas are getting choppy.  There are two lawsuits directed at the company, accusing RB of running a grand scheme to block generic manufacturers from entering the buprenorphine market.  And in denying of the Citizens Petition the FDA adds credence to the lawsuits, even writing that they will refer concerns over anti-competitive business practices to the FTC.  Amazing how quickly things can change; one minute you’re sitting in a deck chair, whistling a happy tune with the wind in your hair… the next, everyone is looking for a lifeboat.

I’ve been writing for years that the company that wants to be viewed as a shiny rescue vessel has been acting more like a pirate ship.  Hopefully last week’s collision will give them pause, and help then realize that it’s not about being the first ship to get to those in need;  it’s more about making sure, once there, that other ships are on the way—and that everybody gets a seat in a lifeboat.