Many lawmakers and health-policy experts say the trend has little downside. "Generic drugs have the same active ingredient that brand-name drugs do and are made in FDA-approved plants, just as brand-name drugs are," says Aaron S. Kesselheim, M.D., an instructor in medicine at Harvard Medical School in Boston. In an analysis recently published in The Journal of the American Medical Association, Dr. Kesselheim reviewed data from 47 clinical studies and found no evidence that patients on brand-name cardiovascular drugs had clinical outcomes superior to those on generics. Given these results, and the lengths that some brand-name-drug companies have gone to protect their patents and profits, it's easy to believe that any supposed problems with generics are "a story cooked up by Big Pharma"—the conclusion reached by consumer watchdog Peter Lurie, M.D., deputy director of the health-research group at Public Citizen in Washington, D.C.

But a yearlong investigation by SELF—including more than 50 interviews and records leaked from one of the world's largest generic-drug companies, Ranbaxy Laboratories—raises questions about whether some new generics are as safe or effective as the brand names. Although Dr. Kesselheim's review looked at all of the available data, many of those studies were completed before the recent flood of generics hit the market and many generic-drug factories moved overseas. In FDA applications for new generic drugs, nearly 90 percent of the factories providing active ingredients are located overseas, where the agency's inspection rate dropped 57 percent between 2001 and 2008.

"The average citizen would want to know that someone is checking that manufacturers are making the drugs they got approval to make," says William K. Hubbard of Chapel Hill, North Carolina, associate commissioner for policy and planning for the FDA from 1991 to 2005 (and no relation to Beth). "That's not happening, and the risk to consumers is potentially huge. I take generic drugs when they're prescribed for me, but my confidence in them is lower than it was a year ago—and going down."

Generics, which came into widespread use after Congress streamlined testing requirements in 1984, are supposed to be tightly regulated. In the late 1980s, after companies were caught paying off inspectors in order to get generic drugs approved, the FDA overhauled its rules. The agency vowed to inspect each factory before giving the green light to any application. And it newly required any generic-drug maker seeking approval to make one test lot of the proposed drug and then to produce three larger lots to show its manufacturing capabilities. "I have told the industry they are in charge of the health of the American public," says Gary Buehler, director of the FDA's Office of Generic Drugs, adding, "We have come a long way in how we do inspections."

But SELF found that the FDA's reforms have largely fallen by the wayside. Few applications trigger inspections, according to sources knowledgeable about the process, and instead of the three required lots, companies are making one or none. Manufacturing problems have come to light, with six generic companies recalling 20 products in 2008. KV Pharmaceutical Company, a maker of heart and pain medicine, recalled everything it made. "The FDA is satisfied that generics are OK," says Nada Stotland, M.D., a psychiatrist in Chicago and the president of the American Psychiatric Association. "My question is, Are we satisfied?"