NY TIMES
Responding to widespread criticism of the government's handling of drug safety problems, the Food and Drug Administration announced Tuesday that it was creating a board to advise it on drug complications and to warn patients about unsafe drugs.
... soon tap into large databases, including those at the Medicare agency, to uncover dangerous side effects in drugs already on the market.
... committees are investigating the agency's ability to discover drug dangers. It also comes on the eve of a landmark three-day advisory panel hearing into the safety of the pain pills Celebrex, Bextra and Vioxx, a hearing that could prove embarrassing to the agency.
..."Our culture, which has received some criticism in recent months, is not to alarm the public when we get a signal," Dr. Crawford said. "That era is sort of past. What the public, we think, is demanding is to know as soon as we know what's going on. And they're fully prepared and adult enough to interpret whether or not this is a final decision."
... the Office of Drug Safety is almost powerless to uncover it. The office is part of the agency's drug review center.
... "It's a huge opportunity that's been lost to introduce transparency and restore confidence in the system."
... Senator Edward M. Kennedy, Democrat of Massachusetts, said the F.D.A. needed to do more. "It is critical that F.D.A.'s resources to monitor drugs be dramatically increased, and the F.D.A. must be given the authority to require drug companies to initiate and complete appropriate safety studies," Mr. Kennedy said.
... "We need to find reasons to make the information available rather than simply saying we can't reveal trade secrets," Dr. Crawford said. "We're in an era of openness."
... The number of warning letters on misleading advertisements issued by the agency has steadily declined in recent years.
The F.D.A. will be under scrutiny for the rest of the week at an advisory panel meeting that will explore the safety of Celebrex, Bextra and Vioxx and how the agency regulated them. Merck, the maker of Vioxx, withdrew the drug from the market in September after a trial showed that it doubled the risk of heart attacks and stroke. Recent tests of Celebrex and Bextra, both made by Pfizer, have shown that those drugs may also hurt the heart.
