FDA Nominee Stalled Over Contraception Controversy

President Bush's nominee to head the Food and Drug Administration doesn't look much closer to confirmation following a Senate hearing.

No senator questioned Andrew von Eschenbach's qualifications to lead the FDA. But several say they won't allow a vote on his nomination until the FDA rules one way or the other on a three-year-old request to sell the morning-after birth control pill without a doctor's prescription.

Von Eschenbach told the drug's manufacturer Monday he's willing to discuss the matter further, but he declined to give the senators a specific timetable for a decision.

That leaves the most likely scenario a recess appointment by President Bush. Senators warned such an act would be considered highly provocative, but they would have little recourse. — Julie Rovner

ADHD Drug Gets New Warnings

July 31, 2006 — Manufacturers of attention deficit-hyperactivity disorder drugs will not have to add new "black-box" safety warnings. There are already special warnings on ADHD drugs about addictiveness and misuse that can lead to heart problems.

The FDA asked two advisory committees last winter if more were needed. One committee called for a new black-box warning about increases in blood pressure and heart rate. The second said an information packet would be enough.

Last week, without fanfare, the FDA approved a new label for Shire Pharmaceutical's ADHD drug Adderall. There's no black box, but there are new warnings in the middle of the label. They include more specifics on cardiovascular problems and new psychiatric advice that doctors should be cautious in prescribing Adderall to people with manic depressive disorder. The label also advises doctors to monitor patients should for new psychotic symptoms or increased aggression. — Joanne Silberner

FDA Issues Raw Oyster Alert

July 31, 2006 — Raw oysters harvested from the Pacific Northwest should be avoided due to reports of stomach illnesses. The Food and Drug Administration says the sicknesses are linked to bacterial contamination.

FDA officials say more than 70 people in Washington state have reported getting sick after eating oysters that are tainted with a bacteria. There are also reports that several New Yorkers have fallen ill from the same Pacific oysters, which are shipped nationwide.

The infection can cause diarrhea and nausea in healthy people. In older folks or those with poor immune system, more serious problems such as blood infections are possible.

In Washington state, authorities are closing off harvesting areas where people have become sick from eating oysters. The state has also recalled shell-stock oysters.

The FDA is advising that people thoroughly cook all oysters from the area, since heat destroys the bacteria. — Allison Aubrey

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