Friday, Sept. 14, 2007
(Washington, DC) – A press report that the White House is opposing a major provision in the FDA reform legislation requiring drug companies make public their clinical trial results would be shocking and disappointing if true, Consumers Union said today. Failing to make such information public would allow drug makers to hide safety problems with their products.
“If this is truly the administration’s position, it’s shocking,” said Bill Vaughan, senior health policy analyst with Consumers Union, publisher of Consumer Reports. “At a time when parents can’t even trust their kids’ toys to be safe, it doesn’t make sense the White House would oppose legislation to help make prescription drugs safer.”
“The drug safety bill now being negotiated in Congress must include honest, accurate, public reporting of clinical trial results, so we know all the benefits and risks of drugs,” Vaughan added. “Researchers, doctors and most of all patients, expect Congress and the White House to make sure the drug industry is making public all the information about their medications, both good and bad.”
A report in Friday’s Inside Health Policy said the White House sent congressional staff an “unofficial statement of administration policy” opposing the House of Representatives’ provision in the FDA reform bill on clinical trial results. Both House and Senate FDA reform bills require drug trials be publicly registered, but the House bill would require a public technical trial results database, as well a lay summary of a drug trials, on the Internet. The Senate bill only calls for a study on how to create such a results registry, and gives the FDA 2 ½ years to implement it.
Both bills are currently being negotiated behind-the-scenes before a final version is sent to the President.
According to the press report, the Administration opposes the House language because it claims that the FDA couldn’t validate the accuracy of the trial results posted, and also because results data is too technical, while lay summaries could have too much bias.
“Instead of proposing ways to make accurate drug trial results public, it appears the Administration is throwing up its hands, which is exactly what the drug industry wants,” Vaughan said. “We hope this isn’t the case.”
Clinical drug trials often show potential safety problems or serious side effects of a medication. Currently, drug makers are not required to make these trial results public, which allows them to play up positive aspects of a drug, and downplay safety problems.
Consumers Union is urging House and Senate negotiators to find a way to immediately make the data from completed clinical trials public, so that independent researchers can check it for accuracy. CU also urges them to establish a system to ensure honest descriptive results of the trials that laypersons can use, and to create that system in a timely manner.
A provision in the Senate bill that could make it more difficult for patients who are harmed by an unsafe drug to sue the pharmaceutical company also should be removed, CU said.
“To truly protect consumers, the final bill must require accurate, public drug trial results, and it must not interfere in any way with the right of patients to hold drug companies accountable in court when they are harmed by unsafe medications,” Vaughan said.