Vol. 4, No. 9: May 31, 2000

The extraordinary progress in women's health in recent years was not prompted by any piece of legislation or government program. In fact, government regulations now deter the development of new drugs that could save the lives of women.

The health needs of women have created a demand which the American Pharmaceutical industry is supplying. Until recently women had no successful treatment for osteoporosis but now the pharmaceutical industry is developing 27 drugs for that disease, in addition to 38 for ovarian cancer and 60 for breast cancer. Overall, pharmaceutical companies are currently developing 370 medicines targeting diseases that disproportionately afflict women, and there is good reason for the dramatic increase in research.

Women make up 51 percent of the population, creating larger market demand. Cancer killed more than a quarter of a million women in 1997, diabetes affects 8.1 million women, and osteoporosis eight million women, who also live longer than men.

Pharmaceutical companies are conducting "gender-based research" on more than 80 medicines. Gender-specific health research examines how women contract diseases and how they react to drugs. For example, heart disease typically develops 10 years later in life for women than men, killing 44 percent of women who suffer hear attacks within a year, compared to 27 percent of men.

But at the cost of lives and billions of dollars, the United States suffers from the most costly and slowest drug development in the world. According to Federal Trade Commission economist Michael Ward, regulations have reduced the drugs available to the population by as much as 50 percent. To make one new medicine available to the public costs approximately $500 million and 12–15 years in research.

A new medicine must go through preclinical testing, an Investigational New Drug Application (IND,) three Phases of Clinical Trials, and a New Drug Application (NDA) that is typically 100,000 pages long, simply in order to meet approval. Only five in 5,000 compounds that go into preclinical testing survive patient testing and only one of these five tested on volunteers is approved. A full 73 percent of medicines approved by the Food and Drug Administration (FDA) between 1987–1993 had already been approved abroad.

Regulations have also driven pharmaceutical research and development abroad, inflating by ten percent the drug patents granted to foreign sponsors, as well as shrinking the number of American pharmaceutical employees. This year the pharmaceutical industry will invest $24 billion in research and development, but the costs are not only monetary. Mortality is part of the price and patients are the victims.

Politicians find it fashionable to attack the pharmaceutical industry for high health-care costs, but the blame lies elsewhere. Regulations increase drug development costs and raise prices for patients. Unfettered by the heavy burden of regulations, pharmaceutical companies could enjoy the freedom they need to stimulate innovation.

The time and costs of drug development will continue to rise until lawmakers put patients first by shortening the approval process. That will spur development and improve the quality of women's lives. Policymakers who claim to favor improved healthcare, especially for women, should bear in mind that it is the medicine, not regulation, that saves lives.

–Laura Dykes

Public Policy Fellow