HHS: Give foreign powers to FDA

The Bush administration wants to hand the FDA more authority over food and drugs made overseas for U.S. use. Yes, it's true. Health and Human Services Secretary wrote two Republicans on the House Energy and Commerce Committee--which has been investigating various FDA issues--to suggest new legislation. "This change would be another arrow in our quiver for FDA's ability to investigate overseas offenders," an HHS spokesperson told the Wall Street Journal.

The question is whether new authority would be enough. As several reports and audits have concluded recently, the FDA has been overladen with mandates and under-endowed with funding. And recent foreign-oversight problems had less to do with the agency's authority than with its incompetence: The heparin scandal still unfolding might have been averted if an FDA staffer hadn't mistaken one Chinese heparin plant for another. The agency didn't inspect Baxter's Chinese supplier because of that mix-up. (There's no proof that the Chinese plant caused the adverse reactions that led to a heparin recall and production shutdown, but it's under suspicion.)

Rep. Joe Barton, one of Leavitt's addressees, told the Wall Street Journal he'd work with HHS on a bill. "China, in particular, has been building a great wall of bureaucracy between our experts and their problem, but American consumers...have a right to know they're safe."

- check out the WSJ article
- see Pharmalot's item

Suggested Articles

Mylan and Pfizer's Upjohn have a name for their pending merger: Viatris. Heard that before? So has Mylan, which owns a subsidiary with the same name.

Intercept presented a data analysis that found treatment with Ocaliva led to "early and consistent improvements" in a range of noninvasive tests.

Days before Amarin faces a pivotal FDA vote on its Vascepa expansion, advisors are set to scrutinize the placebo used in its pivotal outcomes trial.