J&J's Doxil woes show shortages aren't easily fixed

If only drugs followed the rules of Economics 101. Then, when supplies dropped, prices would rise, inspiring more suppliers to get into the game. But for a variety of very basic reasons--regulation being just one--drug shortages aren't so easy to fix. Pharmaceuticals aren't widgets. Making them is complicated. Getting geared up to do so takes time, and so does amping up existing production.

For Johnson & Johnson's ($JNJ) Doxil, the supply problems stem from outsourced manufacturing. The CMO producing it decided to get out of contract work, Reuters reports, amid problems with one of its plants, leaving J&J with a shortage. J&J has been working on moving Doxil to a new manufacturer, but in the meantime, its current CMO is trying to increase production long enough to get a limited supply onto the market within 6 weeks.

That batch probably won't be enough to treat all the patients on a waiting list, J&J says. And until J&J finishes moving Doxil to a new manufacturer, the company expects the drug to remain scarce. J&J told doctors in a letter that Doxil supplies will remain intermittent for several months. "We will continue to provide supplies as they become available," spokeswoman Lisa Vaga told the Wall Street Journal.

The Doxil supply problems have put some patients' treatment on hold and forced researchers to cancel at least one clinical trial, the WSJ says. And Doxil is only one of several key cancer drugs that are running scarce, at a time when the number of drug shortages has  ballooned to record levels. Hospitals and pharmacies have become drug-supply detectives, spending time and resources tracking down scarce products. Gray-market suppliers have stepped into the breach with wildly inflated prices.

Lawmakers have proposed legislation aimed at fixing the problem, and the FDA called a meeting yesterday to consider potential solutions. Speakers suggested developing a national stockpile of critical drugs, opening up the market to imported versions of scarce products, setting up an information system with real-time tracking of shortages and their causes, and beefing up notification requirements for drugmakers. All of these ideas will take time, of course. And so the shortages continue.

- read the WSJ story
- get more from Reuters
- see the MedPage Today article

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