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Efforts to restrict new technology aren’t merely the throes of a Medicare agency grappling with the fiscal woes confronting entitlements. It’s a fulfillment of the bureaucracy’s established aspirations.
On the Op Ed page of today’s Politico.com, I comment on a case that’s being heard before the Supreme Court tomorrow. It concerns drug makers and the issue of federal pre-emption of state tort claims. And it has big implications for the industry.
On Tuesday, the Supreme Court will weigh a novel legal theory being advanced by the trial bar that, if upheld, could become the torts’ next big payday against drugmakers. The case could also undermine the basic tenets of the Food and Drug Administration’s process for approving new medicines.
Another day, and we have another senior level departure from the Food and Drug Administration. The memo below — circulated this afternoon inside FDA — announced the departure of the head of the drug center’s Office of Generic Drugs, Dr. Greg Geba. It’s noteworthy that this new chief had only been in his slot for less than a year.
Several years ago, the federal government entered into a Faustian bargain with the tobacco industry — and the cigarette makers with the government. It was legislation borne of mutual antipathy.
The Food and Drug Administration is expanding its regulation of the Internet. It’s latest incursion? FDA is taking on a drug company’s use of the “Like” button on Facebook.
The announcement last night that Affymax (NASDAQ: AFFY) is recalling all lots of its red blood cell stimulating medicine Omontys could have broader implications for how the Food and Drug Administration (FDA) evaluates similar drugs going forward.