Posted in on February 12, 2008

FDA Ignores Congress and Lets Drug Companies Off the Hook

At Bachus & Schanker, LLC we believe your involvement can make a difference!

Just when we thought the FDA is looking out for America’s best interests…read the following news from Linda Lipsen, Vice President, Public Affairs, American Association for Justice (Formerly the Association of Trial Lawyers of America)

Last month, the Food and Drug Administration (FDA) issued a proposed rule which directly contradicts Congress’ expressed intent when it passed the Food and Drug Administration Amendments Act of 2007 (FDAAA), an act which encompasses the Prescription Drug and User Fee Act. If the rule becomes final, drug companies will enjoy more relaxed labeling requirements and will surely use the rule to claim immunity for failing to warn patients of potential drug hazards.

When Congress passed the FDAAA it included language confirming the responsibility of the drug manufacturer to promptly update its drug label when they become aware of new safety information. Congress was clear that it intended to keep the burden squarely on the drug companies to update warning labels.

Nevertheless, the FDA has promulgated this new rule against Congress’ expressed wishes. Congress explicitly stated that it did not intend to ease the requirements on drug companies to inform consumers of potential drug hazards. It reiterated the need for drug companies to change its label if the drug company learns of reasonable evidence of that risk.

In fact, the drug companies fought and lobbied hard to include language to loosen warning label obligations that the Congress specifically left out of the final bill. But since the drug companies couldn’t get Congress to agree to lessen their responsibilities towards consumers, they turned to the Bush Administration.

Unfortunately, the FDA’s tactics are not new to Bush Administration bureaucrats. Unelected federal agencies have been ignoring congressional directives in a number of other cases. The Environmental Protection Agency (EPA), National Highway Traffic Safety Administration (NHTSA), Consumer Product Safety Commission (CPSC), and others are also engaging in this tactic of Bureaucratic Activism.

How can we undo this system of backdoor tort reform and prevent it in the future?
We are asking Congress take action to safeguard Congressional prerogatives and protect the public. It is important that your Member of Congress hears from you so that they understand that this matters to trial lawyers and, more importantly, your clients.

Contact Congress Today

We are committed to putting an end to this unjust form of backdoor tort reform and will continue to fight against it. Your help in alerting Congress will also be important. We are providing you with a variety of ways to get involved. Our grassroots action center has dedicated a pre-formatted Letter To Congress. All you need to do is add your name and click send.

Contact Congress Today

We also encourage you to take the effort one step further by making a phone call to your Members of Congress. Send a letter, set up a meeting, whatever it takes, let them know how the FDA is letting drug companies off the hook and ignoring Congressional intent. You can look up their contact information easily at

With your help, we can put an end to this bureaucratic activism.

Thank you for your support,

-Linda Lipsen
Vice President, Public Affairs
American Association for Justice
(Formerly the Association of Trial Lawyers of America)

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