FDA Approves Viagra

Like the reliable erection its new product promised, Pfizer's stock had risen 21% in the previous two months.

Some urologists bought rubber stamps so they could churn out prescriptions, and equally excited patients booked advance appointments. Despite all that, Viagra, the world's most popular prescription party drug, didn't have much of a party the day the FDA gave its much-anticipated O.K. to sildenafil citrate. That's because giant pharmaceutical companies—even ones that get a license from the government to print money in blue-pill form—aren't really party places. "We had a nice dinner that night," admits Dr. Ian Osterloh, who directed the development of the impotence treatment.

The drug, originally designed to treat angina (patients still had angina, but some also noted a different kind of agitation they had not had in some time), was approved as expected on the final day of the FDA's six-month priority review. News of the approval immediately went up on the FDA website, the first time the agency notified the public of its decision in real time. And then the world celebrated: Cocoon was played out in every Florida retirement community, marriages moved on to deeper problems, the porn industry was democratized and talk-show hosts got a new way to tell Bill Clinton jokes.

On this day in 1998, the Food and Drug Administration (FDA) approves use of the drug Viagra, an oral medication that treats impotence.

Sildenafil, the chemical name for Viagra, is an artificial compound that was originally synthesized and studied to treat hypertension (high blood pressure) and angina pectoris (a form of cardiovascular disease). Chemists at the Pfizer pharmaceutical company found, however, that while the drug had little effect on angina, it could induce penile erections. The reaction took about an hour, a little longer if the pill was taken after eating fatty foods. Seeing the economic opportunity in such a biochemical effect, Pfizer decided to market the drug for impotence. Sildenafil was patented in 1996, and a mere two years later--a stunningly short time compared to other drugs--it was approved by the FDA for use in treating "erectile dysfunction," the new clinical name for impotence. Though unconfirmed, it is believed the drug was invented by Peter Dunn and Albert Wood.

Viagra's massive success was practically instantaneous. In the first year alone, the $8-$10 pills yielded about a billion dollars in sales. Viagra's impact on the pharmaceutical and medical industries, as well as on the public consciousness, was also enormous. Though available by prescription only, Viagra was marketed on television, famously touted by ex-presidential candidate Bob Dole, then in his mid-70s. Such direct-to-consumer marketing was practically unprecedented for prescription drugs (now, sales and marketing account for approximately 30 percent of the pharmaceutical industry's costs, in some cases more than research and development). The drug was also offered over the internet--customers needed only to fill out an "online consultation" to receive samples.

An estimated 30 million men in the United States suffer from erectile dysfunction and a wave of new Viagra competitors, among them Cialis (tadalafil) and Levitra (vardenafil), has blown open the market. Drug companies are now not just targeting older men like Dole, but men in their 30s and 40s, too. As with many drugs, the long-term effects of Viagra on men's health are still unclear (Viagra does carry warnings for those who suffer from heart trouble), but its popularity shows no signs of slowing. To date, over 20 million Americans have tried it, and that number is sure to increase as the baby boomer population continues to age.