On December 8, 2009 — FDA Pediatric Advisory Committee To Address Vytorin/Zetia Safety

The FDA’s website now bears a notice of recently-scheduled Advisory Committee meetings. On December 8, 2009, starting at 8 am, EST — several drugs (in addition to the above two, which are still among Merck’s billion dollar franchises — but perhaps not for very much longer). Each drug will receive reviews mandated by the Best Pharmaceuticals for Children Act; by December we should know the outcome of ARBITER 6 – HALTS (the smallish niacin study, that most think holds only bad news for Zetia):

. . . .On December 8, 2009, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews. . . for. . . Zetia (ezetimibe), Vytorin (ezetimibe/simvastatin), Ventolin HFA (albuterol sulfate). The committee will also receive a brief update on atypical antipsychotic drugs as requested by the Pediatric Advisory Committee Meeting on November 18, 2008. . . .

I will post background materials, as they become available, in full-text, right here.

House Passes Health Care Reform — 220 to 215

Carl Hulse and Robert Pear, for The New York Times have it thus, tonight:

. . . .Handing President Obama a hard-fought victory, lawmakers voted to approve a $1.1 trillion, 10-year plan that Democrats said could be their defining social policy achievement. . . .

Democrats say the measure — paid for through new fees and taxes, along with cuts in Medicare — would extend coverage to 36 million people now without insurance and would create a government health insurance program. It would end insurance company practices like not covering pre-existing conditions or dropping people when they become ill.

The successful vote came after Mr. Obama traveled to Capitol Hill just before noon Saturday to make a personal appeal for lawmakers to “answer the call of history” and support the bill. . . .

So, now it’s on to the Senate,where — at least many of us believe — the bill can, and will, be improved. But this passage in the U.S. House already places President Obama’s efforts well-beyond where the Clinton-Gore efforts at real health care reform faltered — about 16 years ago.

I do think it is really going to happen — and the package will be improved, in the Senate conference process. If you own health insurance stocks, I’d rethink that, in premarket trading Monday on the NASDAQ.