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August 24, 2007

Third Circuit: FDA Ad Regulation Preempts State Law Consumer Protection Claims

The U.S. Court of Appeals for the Third Circuit has ruled that federal law preempts certain false advertising claims under state law because the U.S. Food & Drug Administration has "exclusive authority" to regulate prescripton drug advertising.  The court ruled that allowing state consumer fraud laws to dictate the parameters of false and misleading advertising in the prescription drug context would pose obstacles to federal objectives in protecting prescription drug users.  A dissenting judge argued that such preemption of state law was unwarranted because the FDA does not have the power to require preapproval of drug advertising and wrong because the agency lacks the resources to police such advertising.  See Shannon Duffy's story for The Legal Intelligencer.


August 24, 2007 | Permalink | Comments (0) | TrackBack

August 21, 2007

Class Action Suits Filed Against Importer of Children's Toys

Suits have been filed in California and Pennsylvania against Mattel, Inc., the importer of Chinese-made toys that have been recalled recently due to lead paint and small magnets that might be swallowed.  The class action filings seek to set up a medical-monitoring fund to pay for testing of children who may have been exposed to lead poisoning from the defective toys.  See Gina Passarella's story for The Legal Intelligencer.


August 21, 2007 | Permalink | Comments (0) | TrackBack

August 16, 2007

FDA Issues Public Health Advisory Concerning Use of Nonprescription Cough and Cold Medicine in Children

On August 15, the Food and Drug Administration issued a Public Health Advisory concerning the use of nonprescription cough and cold medicine in children.  The FDA announced that the Nonprescription Drugs Advisory Committee will discuss the safety and effectiveness of cough and cold drug product use in children in October.  The Advisory states that questions have been raised concerning the safety of those products and whether the benefits of the products justify any potential risks from the use of the products in children, particularly those under the age of 2.  The FDA is reviewing safety and efficacy data for the ingredients of those products in preparation for the meeting.  There have been reports of serious adverse events associated with the overuse of the medicines in children.  The Advisory also provides a list of safety points for parents concerning the use of cough and cold medicines.


August 16, 2007 | Permalink | Comments (0) | TrackBack