Recent legislation has greatly expanded the FDA’s power and ability to regulate drug safety. For the first time since it was granted the power to in 2007, the FDA forced a drug manufacturer to change its prescription information for a specific drug. Producer Amgen was ordered to change the information on its anemia drug, Aranesp. Anemia is a common side effect of chemotherapy, but the drug has been linked to increased risk of heart attack and stroke in patients suffering from cancer. Amgen said it would alert patients and doctors of the new prescribing information immediately.
Additionally, yesterday the House passed legislation giving the FDA the authority to regulate the tobacco industry. While the FDA cannot ban tobacco or nicotine, it can demand the reduction or elimination of cancer causing ingredients in cigarettes and other tobacco products. The FDA should embrace these new regulatory mandates and do a better job of protecting public health and welfare.