FDA Announces Plan for Improvements in Drug Safety Monitoring

HHS Secretary Mike Leavitt and Acting FDA Commissioner Lester M. Crawford unveiled a new vision for FDA that will promote a culture of openness and enhanced oversight within the Agency. As part of this vision, FDA will create a new independent Drug Safety Oversight Board to oversee the management of drug safety issues, and will provide emerging information to health providers and patients about the risks and benefits of medicines. The DSB will comprise members from the FDA and medical experts from other HHS agencies and government departments who will be appointed by the FDA Commissioner. The increased openness will enable patients and their healthcare professionals to make better- informed decisions about individual treatment options. The Agency is proposing a new “Drug Watch” Web page for emerging data and risk information and increased use of consumer-friendly information sheets written especially for healthcare professionals and patients.