FWIW, some general info regarding drug approvals from an FDA related article in todays WSJ($).
Title:Speedy FDA Drug Approvals Please Makers, Worry Consumers
...The FDA's report said the agency issued 83 drug approvals, including 35 for new molecular entities, the FDA's jargon for brand new drugs....
...In 1992, when the Prescription Drugs User Fee Act was enacted, pharmaceutical companies started paying an application fee when drug applications were filed. The act alone raised $327 million, which allowed the FDA to hire 600 new medical reviewers and speed the process....
....Drug companies spent $24 billion on research and development in 1999, up 14.1% from 1998....
....Since the user-fee act passed, new-drug development time has dropped 18%, according to the FDA report.....
And finally the negative according to this individual: ...However, Dr. Sidney Wolfe, executive director of the Health Research Group of the consumer group Public Citizen, said the FDA is pushing meaningless products to market, while not withdrawing some potentially dangerous drugs.
"In the 28 years that I've been monitoring the FDA the quality of work is the worst it's ever been," Wolfe said....
Jim |
