Preemption debate heats up

Tue, 13 May 2008 06:59:58 -0400

That little legal argument known as preemption is back in the news. You know the one: That FDA approval, being federal, supersedes any state-court lawsuits over blessed drugs and devices. Pushed by the Bush Administration, it's set for a Supreme test this fall when the U.S.'s highest court hears a case in which Wyeth claims it shouldn't be liable for claims about an FDA-approved med.

The latest? Supreme Court justices have had to recuse themselves from various cases lately because of their pharma-stock holdings. Yesterday, it was Samuel Alito bowing out because of Bristol-Myers stock. (Four of the nine justices had to sit out of that case, which involved a laundry list of big U.S. companies.) Two months ago, it was Chief Justice John Roberts sitting out a case involving Pfizer. Given the fact that ratifying preemption as a legal defense wouldn't simply help Wyeth, but all drugmakers, will the two men recuse themselves from that case, too? Inquiring minds want to know.

Meanwhile, Congress is dipping into the preemption fray with a hearing on the concept tomorrow. The House Committee on Oversight and Government Reform--Rep. Henry Waxman's group--is calling a bunch of preemption opponents to testify. On the roster: Actor Dennis Quaid, who's suing Baxter over a heparin overdose given to his infant twins.

- see the item at Pharmalot
- check out the hearing announcement

Dems back compulsory licensing

Thu, 10 Apr 2008 06:59:55 -0400

Now Rep. Henry Waxman and 26 of his Congressional counterparts are wading into the compulsory licensing fray. They're questioning U.S. Trade Rep Susan Schwab for her downgrading of Thailand after it issued patent-breaking licenses for three drugs. Though Schwab gave various reasons for putting Thailand on the trade watch list, the reps' letter says the move appears to be a condemnation of compulsory licensing itself. So they're asking Schwab to "reaffirm" the World Trade Organization agreement that allows for those compulsory licenses in public health emergencies at each Member country's discretion.

Can you hear the howling already? As you know, compulsory licensing is controversial in the drug industry; after all, it lets countries bypass the patents on brand-name meds so they can buy cheap copycats. Drugmakers are understandably reluctant. But proponents say that otherwise, patients in poor countries might never get access to the lifesaving meds they need. It's a complex issue, and a contentious one, so you can expect the debate to intensify--especially if Congress decides to get more involved.

- see the House Democrats' letter to the U.S. Trade Rep (.pdf)
- read the item at Eye on FDA
- check out Pharmalot's coverage

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Thailand reconsiders compulsory licenses
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