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WASHINGTON -- Legislation being considered on the Senate floor to revamp the way the Food and Drug Administration approves drug and medical devices for public use is fatally flawed because of a back room deal which opens the door to more Fen/phen catastrophes, according to Consumers Union.
"It is startling that on the heels of the this disturbing story about the dangers of Fen/phen the Senate is ready to vote on a bill that allows doctors to prescribe combination drugs that have never been tested and proven safe and effective in combination," said Adrienne Mitchem, Legislative Counsel to Consumers Union. "Press accounts indicate that thirty percent of the people who take the Fen/phen drugs have developed this horrible heart problem. This situation raises serious questions about whether the FDA is adequately policing drugs on the marketplace. The Senate has an opportunity to take corrective action, and consumers hope Senators seize the moment."
At issue is a last-minute addition made to the bill after it was reported from the Committee on Labor and Human Resources. This back room deal added provisions for so-called off-label use, allowing the drug manufacturers to market drugs which have not been proven either safe or effective. Under current law, drug companies cannot promote drugs for a uses that are not FDA-approved, a practice referred to as "off-label use". Under the so-called FDA reform bill, the pharmaceutical industry's marketing of drugs for "off-label use" through the distribution of articles to doctors would be sanctioned by the FDA for possibly up to five years.
The recall of Fenfluramine, the other half of the popular diet drug combo known as Fen/phen, underscores the danger of the marketing drugs for uses that have not been proven safe or effective by the FDA. Fen/phen was prescribed by a growing number of physicians for its off-label use, until Monday when the FDA determined that many Americans were suffering from a rare form of heart valve damage when using those drugs in combination.
"Under the proposal pending before the U.S. Senate, the American public could be exposed to an explosion of the use of off-label drugs," predicted Mitchem. "Off label promotion amounts to bad medicine. Consumers Union is extremely concerned that this bill will pass in its present form and urges lawmakers to take action to strip this anti-consumer measure from this bill before it is enacted into law."
Consumers Union is urging that the bill be pulled down to avoid this problem. Without a unanimous consent request, Senate rules restrict the ability of lawmakers to offer an amendment on this issue. Absent such action, Consumers Union is urging lawmakers to defeat this legislation.
Consumers Union is also endorsing another change to the bill, offered by Sen. Richard Durbin, D-Ill., to remove a provision which repeals the mandatory tracking and surveillance of implantable medical devices. Mandatory tracking and surveillance is currently required for 17 types of medical devices, including pacemakers as well as hip and shoulder replacements.
"It is a sorry situation when we are tracking autos to ensure that we are able to recall them if the engine wonít start, but won't let public officials track faulty pace-makers or hip replacements," said Mitchem.
