Mr. Outside moves inside
Daniel Troy fought the FDA for years; now he's helping to run it
What is known is that after some of these meetings, Troy took industry's side. On Jan. 15, 2002, Troy and others from the FDA met with representatives from the citrus juice industry to discuss new rules set to go into effect the following week. The juice makers made a last-ditch pitch to loosen one requirement, which they argued would be costly to implement. They told Troy that if the rules went into effect and forced companies to manufacture their product at a single site, there would be no orange juice concentrate left on store shelves. It had taken FDA officials nearly 3 1/2 years to write regulations designed to rid fruit juice of contaminants such as E. coli, a bacterium that has sickened thousands of people and led to a handful of deaths. Nevertheless, a week after the meeting, Troy, with the consent of the FDA's food experts, wrote the industry group that the FDA would use its "discretion" when enforcing the disputed manufacturing regulation.
In June 2002, Troy met with representatives from Fashion Wear Services, the makers of decorative contact lenses that change the appearance of the eye but do not correct vision. The company's lawyers told Troy that its lenses should be regulated as cosmetics rather than as medical devices because the company didn't claim that the lenses serve a medical purpose. A few days after the meeting, Troy told FDA employees the lenses should be treated as cosmetics, which are governed by standards that are less stringent than those established for medical devices. Medical officers at the FDA, who had not been consulted, feared the decision would endanger the public. Decorative lenses already were too easy to get; they were readily available at flea markets and on the Internet. In 2001, for example, Robyn Rouse, a 15-year-old from Cleveland, was nearly blinded in one eye by a tinted contact lens that she bought in a grocery store. Within hours of inserting the lens, she developed a serious bacterial infection, which required her to undergo a cornea transplant operation. In October, four months after Troy's initial recommendation and after further medical review, the FDA issued a public-health alert and banned imports of British-based Fashion Wear's lenses under its authority to regulate cosmetics.
What next? Some lawmakers are not satisfied. Sen. Edward Kennedy, a longtime champion of an aggressive FDA, and others fear the decision to treat the lenses as a cosmetic could set a dangerous precedent and confine the FDA to regulating any product based only on what a company claims it can be used for. These critics say the FDA has the power to look not only at what a company says about its product but also at its use by consumers to determine how it should be regulated. "Simply put," says Kennedy, "this interpretation of the statute could eviscerate FDA's regulatory authority, thwart congressional intent, and severely harm public health."
Troy's instinct to limit the FDA's regulatory authority helps explain his reluctance to let the agency go after ephedra. The FDA had been offered the chance last July, by a Justice Department lawyer, to obtain detailed consumer complaints about a top-selling product containing ephedra that is made by San Diego-based Metabolife International. These "adverse event reports"--which had been introduced in a private lawsuit--could have provided the FDA much needed data to study the supplement's safety. Indeed, the agency had labored for several years, without success, to obtain the documents from Metabolife. But presented with this chance to get them, Troy balked. Dennis Baker, then the FDA's associate commissioner for regulatory affairs, opposed Troy on ephedra, among other matters, and argued that the FDA should take Justice up on the offer. The agency eventually got some documents; under pressure from a Justice Department criminal investigation, Metabolife decided to release the reports.