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FDA’s Response to Drug Safety Critique Falls Short

Jan. 30, 2007

FDA’s Response to Drug Safety Critique Falls Short of Major Changes Needed to Overhaul Nation’s Troubled Drug Safety Program

(Washington, DC.) – The FDA’s response today to a critical Institute of Medicine assessment of its drug safety work includes some minor improvements – such as more sharing of safety data with other agencies – but falls dramatically short of the changes needed to overhaul the nation’s drug safety system.
“If we’re serious about protecting consumers from unsafe drugs, Congress has to give FDA the authority to hold drug companies accountable and perform the safety studies,” Vaughan said.
In addition to Congressional action, Vaughan said the FDA must also be adequately funded to perform its public health duties when it comes to food and drug safety. The President is expected to release his budget for the agency Monday.
“The Administration and Congress have continually failed to seriously fund drug safety efforts. The recent FDA-industry agreement on drug user-fee funding is woefully inadequate, and in today’s report, we did not hear where the new resources will come from. Without money, these announcements are all placebos,” Vaughan said.
Among the changes FDA announced Tuesday was a pilot project to look at the safety profiles of new drugs after they have been on the market for 18 months, and then assess the pilot later. The IOM report, released last year, recommended evaluating the safety profile of a new drug after five years, since the majority of safety problems don’t become apparent until a drug has been on the market between five and seven years. The Enzi-Kennedy legislation recommends a three-year review.
Vaughan said the FDA proposal wouldn’t adequately address the major safety problems that can arise once a drug is on the market and used by millions, and was concerned that it was merely a pilot project.
“The FDA has failed to adequately respond to safety problems in drugs once they are on the market for years and used by millions,” Vaughan said. “Reviewing drugs for safety after 18 months is a good start, but we need periodic, consistent reviews of drugs on the market to catch these major safety issues.”
Some drugs are approved with outstanding safety concerns on the promise that the drug’s maker will perform post-market safety studies to determine if the medication causes side effects over a period of time. But the FDA has no authority under law to require those studies be performed, and a significant number of the promised studies are never done.
The FDA’s response to the IOM report also did not address many of the key IOM recommendations that require legislation. Those include requiring drug makers to publicly register their clinical trial results so doctors and patients have the latest information on a drug’s safety and efficacy; limiting advertising on new drugs with potential safety issues; and giving the FDA the authority to require industry to perform promised post-market safety studies.
Several bills were introduced last year that included many of the IOM’s proposed reforms – including a bipartisan bill by Sens. Enzi and Kennedy that is expected to be reintroduced soon.
“There are many members of Congress on both sides of the aisle who want to give the FDA the tools and resources to do the job right and stand up to the drug companies,” Vaughan said.
Contact: Susan Herold, Bill Vaughan, 202-462-6262