The pharmaceutical industry is one of the most powerful interest groups in Washington -- one that has rarely shied away from wielding its influence with Congress and the FDA. But are the industry's lobbying efforts always good for business?

+ Center for Drug Evaluation and Research (CDER) The CDER is the division of the FDA responsible for review and approval of new drugs, and for monitoring the safety of new drugs once they're on the market. Its Web site offers a brief history of the CDER.

Under the terms of PDUFA, the drug industry agreed to help finance the approval process -- through "user fees" accompanying each new drug application -- in exchange for an FDA promise to speed up its deliberations. Widely considered one of the most significant pieces of legislation in FDA history, it would effect a remarkable transformation: In 1992, it had been taking the FDA an average of 30 months to approve a new drug. By 1996, the agency had cut the time nearly in half, to 16 months, prompting outgoing commissioner David Kessler to announce (accurately) that "the U.S. is now a world leader in drug review."

Probably the single most important shift in the FDA of the last decade has been the change in how the agency approves new drugs -- or, more precisely, how quickly it approves new drugs. In the late 1980s, the pressure to speed up drug approvals was rising. And it wasn't just the drug makers complaining. It was doctors and patients who were agitating, too, over everything from why the FDA hadn't approved the chicken pox vaccine (even though European nations had approved its use for years) to why it wasn't moving faster on potentially life-saving AIDS treatments -- a grievance that famously led to mass protests outside FDA headquarters in Rockville, Maryland. These public displays of disaffection, combined with behind-the-scenes lobbying by pharmaceutical manufacturers and their trade groups, finally produced the Prescription Drug User Fee Act (PDUFA) of 1992.

It's worth keeping that in mind when looking at some of the more recent battles pitting the drug industry against its regulators. Although drug company executives and representatives speak in genial tones when they talk about the FDA publicly, they have also lobbied to make the agency more docile and business-friendly. Because the pharmaceutical industry is one of Washington's most powerful interest groups, many of these efforts have succeeded. But given the history of pharmaceuticals in America, it's fair to ask whether, in the long run, these successes will help the drug industry or hurt it -- by undermining the outside watchdog that guarantees the credibility essential to its financial survival.

As we all now know, none of these dreadful consequences ever materialized. On the contrary, as Philip Hilts recounts in his sweeping history of the Food and Drug Administration, Protecting America's Health (2003), the American pharmaceutical industry not only survived the efforts at regulation during the 20th century, it actually thrived as a result of them. Every time the government demanded something more of the drug industry -- every time it raised its standards for safety or efficacy -- the industry responded by making better products that enjoyed more consumer confidence, which ultimately meant not just better medicines for patients but bigger profits for the drug companies. "The regulations and the government shepherding of the drug business did what the free market failed for at least sixty years to do," Hilts wrote of the 1938 law, although he might well have been writing about any one of the major drug safety acts during the last century. "It weeded out the brutal, the stupid, and the needless that prevented the pharmaceutical industry from becoming a great engine of discovery and sales."

The relationship between drug manufacturers and those who would regulate them had not improved much by the 1930s, when Congress was on the verge of passing the first law requiring drug makers to demonstrate that their products were safe before selling them. The bill, industry groups wrote in a letter, "will put thousands of men and women out of work. It will close dozens of manufacturing plants and hundreds of stores. … It will help none." And in the 1960s, when Congress was about to pass a law requiring drug companies to demonstrate that drugs were not merely safe but were effective as well, the pharmaceutical industry once again warned of dire consequences -- specifically, that drug prices would rise, innovation would slow, and millions would lose their jobs.

In 1906, when Congress was about to pass the first federal law to protect food and drug safety, a trade group representing companies that made medicines (or what passed for them back then) warned darkly: "Such a law would practically destroy the sale of proprietary remedies in the United States."