February 15, 2005 -FDA Announces Reforms for Drug Safety

One day after President Bush named a new head of the federal Food and Drug Administration (FDA), Secretary of Health and Human Services (HHS) Mike Leavitt announced today that FDA will take steps to manage safety issues that have plagued the drug industry in recent months. Under new commissioner-designate Lester Crawford, the FDA will create an independent Drug Safety Oversight Board, comprised of members from the FDA and other HHS agencies and government departments, which will consult with outside medical experts and representatives of patient and consumer groups. The FDA will also create a Drug Watch Web Page, where drug information will be given to health care professionals and patients even before the FDA has reached conclusions about the medications' safety. Also available will be one-page information sheets for health care professionals for all drugs on the FDA's "drug watch" list, including potential safety issues. More detailed information about the new initiatives can be found on the FDA website at www.fda.gov/cder/drugsafety.htm.