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Better Late Than Never: FDA Acts on Lethal Painkiller Patch Maker

The FDA has finally gotten around to scrutinizing the manufacture of fentanyl patches -- an extremely addictive and frequently fatal painkiller delivered via an unreliable sticky patch worn on the skin.

Regular readers will know that I have railed against fentanyl patches -- and their propensity for turning patients into addicts -- for nearly three years. Fentanyl is 80 times more powerful than morphine. Doctors like it because it is short-acting. Unfortunately, it kills dozens of people a year through accidental overdoses and abuse.

In February, the FDA inspected the fentanyl patch factory of Noven Pharmaceuticals, and it did not like what it saw. The FDA's warning letter, released a few days ago, is full of complex regulatory mumbo-jumbo, but here is what it boils down to:

  • Inadequate controls regarding the strength and purity of the drug.
  • Brown particles found in a sample of the patch adhesive solution.
  • No data on whether the adhesive mixing process works.
  • Missing patches unrecorded.
To recap, aside from the drug itself and the patch it's delivered on -- the entirety of the product, in other words -- there's nothing else wrong with Noven's fentanyl patches.

Noven has a history of failures when it comes to patches. It once had a contract with Shire (SHPGY) to make Daytrana patches for ADHD. But after nine product recalls due to Noven's faulty manufacturing Shire gave up on the relationship.

At rival maker Watson Pharmaceuticals (WPI), lawyers have won the right to interrogate executives in depositions about design flaws in the patch.

When used wrongly, fentanyl can turn a normal person struggling with chronic pain into an addict so crazy that he will dig through piles of medical waste to lick used patches.

Hopefully the FDA's probe of patch makers will branch into a wider investigation of how much fentanyl is used for legitimate medical conditions and how much is simply diverted by patient addicts and crooked doctors.

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