September 22, 2006
(Washington, D.C.) – Today’s scathing report on the FDA’s drug safety system by the Institute of Medicine should set off warning bells in Congress that it must reform the nation’s broken drug safety system now, and put in place an open process where the pharmaceutical industry can no longer hide critical safety information and consumers can have faith in the medicines they take, Consumers Union said.
“The nation’s premier doctors and scientists are saying the drug safety system is broken, and they have laid out a plan to fix it. Congress simply can’t ignore this real problem any longer, because too many lives are at stake,” said Bill Vaughan, senior health policy analyst with Consumers Union, publisher of Consumer Reports.
The IOM recommendations echoed many supported by Consumers Union, including mandatory registration of clinical trial results so doctors and patients have the latest information on a drug’s safety and efficacy; limiting advertising on new drugs; more authority for the FDA to require pre- and post-market safety studies and to fine safety offenders; and ensuring drug risk information gets communicated to doctors and patients.
“The IOM report is the first in-depth critique of the problems that exist in assuring drug safety for all patients,” said Dr. Marvin Lipman, Consumers Union’s chief medical adviser. “Congress should heed these recommendations and restore the FDA’s ability to carry out its primary mission to protect the public health and welfare.”
Several bills have been introduced that include many of the IOM’s proposed reforms, but none have had a hearing. The co-chairs of the Senate Health Committee, Sens. Enzi and Kennedy, recently introduced legislation to reform
the FDA drug safety system (S 3807). Other pending legislation includes clinical trial registration and FDA reform pushed by Sens. Grassley and Dodd and Reps. Waxman, Markey, Tierney and Ramstad (S 470/HR 3196 and S 930/HR 4429), as well as House bills on direct-to-consumer advertising and post-market safety, backed by Reps. Hinchey, DeLauro and others.
“Drug safety isn’t a political issue, it’s a public health issue,” Vaughan said. “There are many members of Congress on both sides of the aisle who want to give FDA the tools and resources to do the job right and stand up to the drug companies. This report is a real opportunity for Congress to pass bipartisan, landmark legislation now.”
Consumers Union also applauds the emphasis in the IOM report on opening up the process and eliminating conflicts of interest from the pharmaceutical industry caused by the current user fee system. A House bill, HR 2090 (Hinchey), would restore the independence and freedom of the FDA from the pharmaceutical industry’s payment of user fees, which have gone primarily to drug approval while neglecting drug safety.
The IOM also emphasized examining safety over the cycle of a drug’s use – including its usage years after approval when many safety issues begin to arise. Similar measures are included in the Enzi-Kennedy bill.
“We look forward to working with Congress to pass legislation that will restore consumers’ confidence in the medicines they take each day,” Vaughan said.
Bill Vaughan or Susan Herold: (202) 462-6262