FDA unpopular over label liability revamp

Jan 19 2006

The Food and Drug Administration in the U.S. has said that federally approved drug labels pre-empt state liability laws and are part of a revamp of the lengthy, hard-to-read instructions that come with medicines.

It also says that the pre-emption of state laws address drug makers' concerns that the streamlined summary of risks could increase their liability if patients alleged the warnings were inadequate.

Many critics believe the FDA has overstepped its authority in order to protect drug makers from lawsuits.

According to Dr. Scott Gottlieb, FDA deputy commissioner for scientific and medical affairs, drug labels had become "cluttered with a lot of information that wasn't necessarily directly pertinent to patients and physicians and had become disclaimers rather than important health tools.

The new format is apparently aimed at helping doctors find important information quickly.

The updated design has a "highlights" section that summarizes the most important details about potential benefits and side effects, and a table of contents to help find more information.

In introducing the new rules for drug labels, the FDA said it believed its approved prescribing information preempts conflicting or contrary state law.

Gottlieb says the language was a restatement of a position the FDA had taken in state lawsuits against drug makers.

The Bush administration has been in favour of pointing litigants towards the more stringent federal courts, and early last year President Bush passed a law shifting most class-action lawsuits into the federal courts.

Many, including Senator Edward Kennedy, a Massachusetts Democrat, object to the FDA move, and regard it as yet another example of the government manipulating events to protect the drug industry.

The National Conference of State Legislatures has declared the language used "a thinly veiled attempt on the part of FDA to confer upon itself authority it does not have by statute, and does not have by way of judicial ruling".

Drug industry group, the Pharmaceutical Research and Manufacturers of America, says it is important that efforts to clarify risks and benefits by drug companies is not rendered useless by 50 different sets of product liability laws in various states, particularly after a detailed review by FDA experts.