August 2008: FDA Issues Its Final Version Of A New Rule Which May Give Complete Immunity To Drug And Medical Device Companies

FDA Rule Could Serve To Defeat Lawsuits Alleging Failure To Warn About Potentially Harmful Effects Of Prescription Drugs And Medical Devices

(Posted by Tom Lamb at DrugInjuryWatch.com)

Back in February 2008, in a post titled, "FDA Proposed Rule About Drug Label Warning Changes Will Lessen Agency's Power To Protect Us", I told you about a proposed rule that was issued in mid-January by the FDA.  In essence, it said that a drug company would only have to revise the package insert, or label, for its prescription drugs and add an increased warning about a serious side effect where there was “sufficient evidence of a causal association” between a a drug and a serious side effect.  Notably, this determination would be made not by the FDA but by the drug company, itself, i.e., the same entity that sells its medications for profit.  In that earlier post I set forth the three main things which I thought were wrong with this new proposed rule issued by the FDA.

More significant than my opinion, eight Representatives and Senators wrote a January 23, 2008 letter objecting to this FDA proposed rule.  Two fundamental points made in that letter were: (1) The proposed rule set a higher standard for when drug and medical device companies could make changes to a product label to alert doctors and patients about new safety information without waiting for FDA approval; and (2) The proposed rule would have the practical effect of protecting drug and medical device companies from being sued by injured patients for failing to disclose risks associated with their unsafe products.

Well, it seems that the FDA did not listen to me nor did the agency take the guidance offered to it by those eight lawmakers. 

In an August 21, 2008 Bloomberg article, "Drugmakers Given Legal Shield By Rule, Lawyers Say (Update1)", by reporter Justin Blum, we learned the the FDA has issued in final form this rule that had been only "proposed" previously, and that this new FDA final rule is now posted on the agency's web site.

What this new FDA final rule means depends on who you talk to or, more exactly, who Mr. Blum interviewed.  From his August 21 article we get these several different perspectives:

• Randall Lutter, the FDA's deputy commissioner for policy: "This action should reduce confusion about what our policy is, clarify it and provide additional confidence to patients and doctors that information on medical product labels has a sensible scientific basis."
• Ken Johnson, the Pharmaceutical Research and Manufacturers of America's senior vice president:  "[Doctors and patients] look to the FDA -- widely considered the world's gold standard -- to provide them with balanced information."
• Gerie Voss, director of regulatory affairs for the American Association for Justice:  "The final rule is going to give drug and device companies the ability to claim complete immunity for failing to warn about potentially hazardous side effects of prescription drugs and medical devices."

I presume there will be plenty of commentary from all sides forthcoming about this new FDA final rule and what it means in terms of drug and medical device safety as well as product liability lawsuits for injured patients.

Of course, I welcome your opinion on this issue.  Please feel free to submit a Comment to this post and let us know what you think.