Eagle-Eyed Regulators

A two-year battle ended last week in a major defeat for deregulators when Congress overruled a controversial Food and Drug Administration (FDA) decision.

Two years ago Daniel Troy, the first political appointee to become the agency's top lawyer, stripped the FDA of its ability to regulate cosmetic contact lenses. That action set Troy against the medical profession, manufacturers -- and the FDA's own scientists.

Troy's decision caused an uproar at the FDA. “Agency officials were very upset, very demoralized about what happened,” one former top official says. “Some almost quit.”

But on Wednesday, October 26, the House followed the Senate's lead and unanimously passed a bill reasserting the FDA's oversight over decorative contact lenses.

Troy, who left the agency last December amid much controversy, was one of the most outspoken of the anti-regulatory ideologues given top regulatory posts at the FDA over the past five years. Troy came to the agency from private law practice, where he had spent years suing the FDA in an effort to curb its authority. He set in motion the contact-lens battle soon after coming to the agency in August 2001. The fight that ensued typified many similar battles throughout this administration that have pitted political appointees and their agency co-thinkers against career staff supporting a strong FDA. These conflicts have left the agency weakened and shell-shocked.

The result has been years of headlines warning that senior FDA officials knowingly allowed dangerous drugs to remain on the market, suppressed warnings by agency scientists of problems, approved products with little benefit, and refused to force companies to correct major manufacturing problems. Congress, despite hearings confirming widespread problems at the top of the FDA, has done nothing. However, the decision to reassert agency authority over cosmetic lenses, albeit after hundreds of injuries, at least offers a glimmer of hope.

Decorative lenses have been marketed for decades to actors needing to change their eye color or to patients with facial disfigurements. The FDA regulated them as it did lenses to correct vision (as medical devices), oversaw their safety and manufacturing, and required that they be obtained only through prescription from an eye-care professional.

However, over the last several years they have become easily available on the Internet; sold at flea markets, beauty parlors, even gas stations; and marketed to teenagers who wanted to change eye color or use them as part of a Halloween costume.

Significant injuries started surfacing. Members of the Georgia Board of Optometry found almost 800 patients hurt by the lenses over a two-year period. In 2002, summer fun at Myrtle Beach, South Carolina, was marred by news reports of injuries to people who had bought costume lenses from beachwear stores. Dr. Thomas L. Steinemann at MetroHealth Medical Center in Cleveland wrote a chilling medical-journal article on 17 cases of major eye infection, four landing patients in the hospital and one resulting in a corneal transplant to a 14-year-old.

But while FDA scientists were looking at ways to crack down on illegal use of the products, Daniel Troy had other ideas. He saw the cosmetic-lens issue as not only a chance to deregulate a product but as a way to make a broader statement about FDA power. And many FDA career staff feared he wanted to set the stage for deregulating other products.

In June 2002 he circulated a proposal to officials at the FDA's Center for Devices proposing that the lenses be regulated as cosmetics rather than medical devices. Troy argued that, because the lenses were not meant to correct vision problems, they were decorative and should be considered cosmetics. The change would mean that the FDA could not require that they be sold only through prescription and would be virtually powerless to stop sales in such places as flea markets. It would also limit the agency's ability to oversee the safety of the product itself.

The general counsel's position overturned the long-standing FDA view that if a product affects the body, regardless of its intended use, it is a device. “He believed it was not the device itself but the claims made for the device that determined how it was regulated,” says Wally Pellerite, who was a top compliance officer at the device center for 21 years.

FDA scientists feared Troy's stance could be used to drastically erode the agency's regulation of many other products, such as breast implants and collagen injections, if a company claimed it wanted to sell these only for cosmetic purposes

Troy's actions were undergirded by a philosophical disdain for strong government oversight of industry, a belief widely shared by the political appointees at the FDA but perhaps most directly articulated by Troy himself. He considers himself an “originalist” in the tradition of his mentor Judge Robert Bork, whose Supreme Court nomination was blocked by Democrats in 1987. (Originalists argue for a literal reading of the U.S. Constitution to comport with their interpretation of the views of the Founding Fathers, rather than applying it flexibly to changing times.)

This is in sharp contrast to long-held policy at the FDA, where officials had always taken the view that they had a broad mandate to correct food or health problems. Mary Pendergast, the agency's deputy commissioner from 1990 to 1998, says that when she was at the FDA, “We kept saying that the Food, Drug and Cosmetic Act is the Constitution, and we would read it broadly.” But, she adds, “It seems that Troy thought that if it isn't specifically authorized in the act, then he was not inclined to do it.”

Even as the FDA's chief counsel, Troy co-authored a paper with Bork arguing that the government does not have the right to oversee industry. They maintained that the Constitution's commerce clause does not give Congress the power to regulate manufacturers, only to oversee trade. Such a view “would eliminate most of the FDA's work,” says George Washington University law professor Peter J. Smith. “Most of the regulatory state would be eviscerated.”

Medical personnel, especially optometrists and ophthalmologists, were equally outraged, fearing many injuries if people used lenses without a doctor's care. Manufacturers, too, were concerned, fearing their products would be blamed for the growing number of injuries. And many had already gone through the regulatory process and wanted new companies to compete on a level playing field. Democratic Representative Henry Waxman wrote then-Health and Human Services Secretary Tommy Thompson in August 2002 about Troy's plan, urging him to stop it.

Faced with tremendous dissension throughout the FDA, the medical community, Congress, and manufacturers, Troy wanted the imprimatur of the commissioner, at the time former White House insider Mark McClellan, on this change. The commissioner's office forced the policy on career staff.

By late 2002, Troy was advising a British manufacturer on how to market the product as a cosmetic, even while Thompson was assuring Waxman that the FDA had no intention of changing agency requirements on cosmetic lenses.

The new FDA policy was publicly signaled by a statement from Troy's office on April 1, 2003. Infections and other medical problems continued. Steinemann says his hospital has seen dozens of injured teens. The American Academy of Ophthalmologists and the American Optometric Association, along with U.S. manufacturers, has lobbied hard on Capitol Hill. More than two years later Congress finally reasserted stronger FDA oversight, at least on this issue.

Barbara T. Dreyfuss is a freelance writer based in Alexandria, Virginia.