Fifty years of "the pill": risk reduction and discovery of benefits beyond contraception, reflections, and forecast.

Widely regarded as a revolutionary drug in its early years, "the pill" may be considered the first designer or lifestyle drug. Approximately 85% of women in the United States will use an oral contraceptive (OC) for an average of 5 years. Since the introduction of OCs in the 1960s, both health benefits and safety concerns have been attributed to their use. Widespread use of OC formulations by women throughout their reproductive life cycle gave rise to concerns about the effects of OCs on risk factors for cardiovascular disorders and cancer. In most instances, the noncontraceptive benefits of OCs outweigh the potential risks. As with many first in class drugs, lessons can be learned from its development and use. Indeed, "the pill" played a significant role in reshaping the regulatory process for new drugs during the second half of the 20th century. The birth control pill celebrates its 50th birthday this year, as women and men celebrate five decades of this revolutionary method of family planning. Recent scientific and technological advances in genomics, proteomics, new materials, and new drug delivery systems, along with a new understanding of reproductive biology, offer the promise of new, safe, and effective forms of contraception. In addition to the history of OC therapeutic advances and unintended side effects, the noncontraceptive health benefits that women experience beyond pregnancy prevention are discussed. This article summarizes a symposium presented at the 50th Anniversary of the Society of Toxicology National Meeting, held from 6 to 10 March 2011 in Washington, DC.