drugmakers given legal shield by rule, lawyers say
21 Aug 2008

The rule posted today on the Food and Drug Administration's Web site is likely to result in fewer company-initiated changes to package inserts and protect those selling products when they have ``knowledge of potentially hazardous side effects,'' said Gerie Voss, director of regulatory affairs for the American Association for Justice, a Washington-based group of trial lawyers.

Eight Democrats from the House and Senate objected in January after the FDA published a proposed version of the rule. The lawmakers said in a letter that the measure sets a higher standard for when companies can make changes to package inserts alerting consumers to new safety information without waiting for FDA approval. The effect would be to protect companies from being sued for failing to disclose risks, the lawmakers said.

``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,'' Voss said today in a telephone interview.  The rule clarifies an FDA policy that has long been in place, said Randall Lutter, the agency's deputy commissioner for policy, in a telephone interview. It allows companies to add information to product labels before an FDA review is complete in certain circumstances, he said.

``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,'' Lutter said.

The Pharmaceutical Research and Manufacturers of America, a Washington-based trade group, supports the FDA rule, said Ken Johnson, the association's senior vice president, in a statement. Doctors and patients ``look to the FDA widely considered the world's gold standard to provide them with balanced information,'' Johnson said.  To contact the reporter on this story: Justin Blum in Washington at jblum4@bloomberg.net.

Justin Blum,  www.bloomberg.com