Uniformity Issues Delay Senate FDA Reform Bill

The US Senate version of the Food and Drug Administration modernizationbill was to have been called up at noon Monday, August 28, with debate underway to 15:00. After this, the amendment would have been put forward and voted on Wednesday, August 30. However, this did not happen.

By the middle of last week, agreement on national uniformity relating to over-the-counter medications and cosmetics had still to be reached. A spokesman for the Nonprescription Drug Manufacturers Association told the Marketletter that a major concern was that two Senators from California had made clear their preference for the state's Proposition 65 (which requires businesses to either warn the public that they are being exposed to carcinogens and reproductive toxins or remove these chemicals from their products) to be grandfathered.

The NDMA's worry is Prop 65's "bounty hunter" provision; this allows anyone in the state to bring lawsuits against companies, claiming violations of Prop 65. Some bring the action only to get a settlement from the companies which hope to avoid prolonged litigation, he said.