The Food and Drug Administration announced some changes to monitor the safety of drugs. One strategy is to make an assessment of a drug once it's been on the market for 18 months. A second strategy is to form "an advisory panel to improve the way it announces safety worries." Apparently, this isn't good enough for Senator Christopher J. Dodd (Democrat, CT):
Mr. Dodd promised to introduce two bills today that would reorganize the F.D.A. and require drug makers to disclose the results of all clinical trials involving humans. The bills’ co-author, Senator Charles E. Grassley, Republican of Iowa, has called the agency far too “cozy” with drug makers.
Ummmm...from the article:
There are now thousands of drugs in routine use. Figuring out which of these medicines may have undiscovered side effects will take a lot of money. The agency gets about $400 million of its $1.9 billion budget from fees assessed on drug makers. Under a formula negotiated with the drug industry, this money comes with strings attached. One restriction was that the F.D.A. could use little of the money to track the safety of approved drugs.
That deal between the F.D.A. and drug makers expires this year, and the drug companies have agreed to allow more of their money to be used for postmarket safety assessments. Whether those fees are enough, whether there should be any strings attached to them and whether that money should be coming from drug makers at all has become the subject of fierce debate.
Fasten your seatbelts...(sorry, that's my "homage" to "All About Eve")! Click
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