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In June 2002 a contact lens entrepreneur named Kashol Pungi traveled to the United States to threaten the Food and Drug Administration. Pungi’s Fashion Wear Services, Ltd., based in Alford, England, was selling tinted, noncorrective lenses in Europe and Canada, and he wanted to sell lenses in the lucrative American market, too. Usually, the FDA requires manufacturing inspections and safety studies from contact lens makers before allowing their products into stores. But Pungi � most people call him Kash, as in money � did not want to wait. In a meeting at FDA headquarters, Pungi and his lawyers from the Washington, D.C., boutique of Hyman, Phelps & McNamara told Daniel Troy, chief counsel of the public health agency, that the law couldn’t stop Fashion Wear. They argued that the FDA could only regulate a product according to the manufacturer’s claims for it. And Fashion Wear touts its lenses only as fashion accessories, not as medical devices. In Europe, Pungi’s company peddles lenses to style-minded teenagers who want to match eye color to outfit � or do something even cooler, like flash a lizard’s eye or a biohazard warning sign from their eye sockets. Shortly after, Troy told agency supervisors that he was downgrading the oversight of these lenses � from the medical devices enforcement bureau to a small team that oversees lip gloss, leg waxes, and other cosmetic products. This averted a sure lawsuit, he says: “If somebody writes me a letter of the kind of letter that they have written me, and they say they’re prepared to litigate the case against me, what am I going to say, ‘No, they’re not going to do it’? I don’t think we do well when we count on not being sued.” Troy’s approval for Fashion Wear to sell its lenses inflamed congressional Democrats. The legislators presented in letters cases of teenagers who bought theatrical lenses without a professional fitting and developed conditions that eventually required corneal transplants. The big U.S. manufacturers of tinted lenses complained about Troy’s decision, too. Because of these dangers, they had long regulated themselves � requiring buyers to have a prescription and submitting safety tests to the FDA before initiating sales. They even had agreed to call their lenses “medical devices,” which the FDA controls more stringently than cosmetics. Challenged publicly, Troy within two months reversed course and took aim at the English company. The Federal Food, Drug, and Cosmetic Act, written in 1938, requires the makers of cosmetics to substantiate their products’ safety. Troy decided that the FDA could argue that even purely cosmetic contact lenses are safe only if used under medical supervision. So in October he authorized a double attack. Within the U.S., FDA agents would seize all noncorrective lenses sold without a prescription. To thwart overseas manufacturers like Fashion Wear, the FDA asked the U.S. Customs Service to seize such lenses at the borders. The seizure action spared the major U.S. manufacturers, and, so far, has kept Pungi from exporting Fashion Wear lenses to America. Few cosmetics have ever been seized, says Troy, but the law allows it: “Under our pretty ample cosmetics authority, we can still ensure that the public health is protected.” 20/20 HINDSIGHT Troy’s solution to the contact lens imbroglio combined integrity with deftness, says Jonathan Javitt, a friend of Troy’s and an ophthalmology professor at Johns Hopkins University School of Medicine. On behalf of the American Association of Ophthalmologists, he had lobbied his pal to designate the lenses a public health menace when unprescribed. “I think the FDA was able to react within a very short time frame to address a clear hazard to the public’s health, using law that would clearly stick,” Javitt says. But U.S. representative Henry Waxman (D-California) and others say that Troy, faced with political opposition, really just pulled a fast one. Preternaturally inclined against regulation, the FDA lawyer first defined down oversight of a product that the domestic industry itself treats as a medical device. Only after a hue and cry was raised did he act against the lenses � using the enforcement provision of a weaker regulatory regime. Waxman says the result sets a terrible precedent: “Manufacturers will be encouraged to avoid meaningful regulation by claiming that their product has a cosmetic or recreational purpose rather than a medical purpose.” Nor, say critics, was this an isolated zigzag. They complain that the FDA, which regulates nearly $1 trillion of products, has for nearly two years been steered by the crafty, conservative lawyer whose private sector career featured spirited advocacy against the very agency he now helps run. Opponents describe Troy’s techniques as regulatory sleight-of-hand: ad hoc shows of enforcements that mask more systemic deregulations. He’s drawn additional criticism for saying that food and drug law prevented an eminent domain seizure of Bayer Corporation’s inventory of Cipro during negotiations over the national supply of the antibiotic, and for allegedly dragging his feet on warning letters directed at the industry. Troy also flouts convention by opening a back door for lawyers who want a private hearing with him to appeal their case, and former FDA officials have lambasted him for failing to take notes during those meetings. Additionally, the detractors contend that Troy is using his position to limit plaintiffs’ options in personal injury litigation � while disguising that effort as a campaign for public health. On top of it all, Troy’s approach might seem at odds with the unanimous 1969 Supreme Court decision that has largely informed the past generation of agency activity: “The Food, Drug, and Cosmetic Act is to be given a liberal construction consistent with the act’s overriding purpose to protect the public health.” To all this, the 43-year-old Troy replies that he is protecting the agency from the kind of enervating court losses that his predecessors suffered due to misguidedly aggressive positions. Troy notes that he joined the FDA at a time when judges had ruled against it on several consecutive high-profile cases. When formulating the agency’s position, he says, “we need to examine where the courts are today. . . . The public health cannot abide an FDA that lacks credibility in court.” But how credible is Troy’s approach? On the lens decision, Representative Waxman says that Troy is misleading the public about the state of the law. “The FDA appears to be exaggerating the risk of losing a lawsuit,” says Waxman. “The FDA has a long history of regulating these lenses as medical devices.” Troy’s break with contact lens precedent also affects products beyond decorative lenses. The FDA always has preapproved lens cleaning solutions, for example, but now manufacturers of these products may tell the FDA to leave them alone. “Lens care products labeled solely for use with decorative lenses would also avoid medical device classification and the public safeguards associated with device classification,” says Tom Henteleff, a lawyer for the Contact Lens Institute, an association of lens and lens care product makers. Ironically, there’s one other problem with the solution that was designed by this self-proclaimed litigation risk monitor: It’s legally perilous. No case law supports the FDA’s restricting who can sell a cosmetic � it’s always allowed over-the-counter sales of any product that it has designated a cosmetic. Says Robert Brady, a former executive vice-president of the Cosmetic, Toiletry & Fragrance Association who now practices at Washington, D.C.’s Hogan & Hartson: “That tinted contact lens rationale has never been used before, and in my judgment will never been used again.” CONSERVATIVE BONA FIDES Troy has long exhibited a skepticism about government. Growing up in New York City during the 1970s provided the seed. His parents taught in the public schools, and though loyal Jewish Democrats, they kvetched about the decline of the city. That got their son thinking about the private sector. “When taxes were incredibly high, services were close to nil, the city was teetering on the brink of bankruptcy, and schools not helping anyone, it was hard to believe that government was the first and best solution to all social ills,” the Queens native recalls. After attending Columbia University School of Law, he clerked for Judge Robert Bork of the U.S. Court of Appeals for the D.C. Circuit, known for his strict reading of the Constitution. In the late 1980s Troy spent two years at the U.S. Department of Justice during the administrations of Ronald Reagan and the first George Bush, leaving to work on Rudolph Giuliani’s first, unsuccessful run for mayor of New York City. Around then, Troy also joined the Federalist Society (a group of conservative and libertarian lawyers with an ambitious political and legal policy agenda). After clerking with Bork, Troy had planned to be an entertainment lawyer, but that dream faded after two years of practice at New York’s Paul, Weiss, Rifkind, Wharton & Garrison. “I realized that the people who did best in entertainment law were not people, like me, who really enjoyed reading cases and writing about the law,” he says. Troy landed at Washington, D.C.’s Wiley Rein & Fielding in 1990. Soon after, he joined the American Advertising Federation’s legal affairs committee, where he argued that the federal government overly restricted corporations’ speech. He also moved deeper into conservative intellectual circles, signing on as a scholar for the American Enterprise Institute. In 1998 he wrote a monograph critiquing an abstruse practice that irked businesses, “retroactive legislation,” which involves statutory demands on companies to redress past lawful acts such as toxic waste dumping. While at Wiley Rein, Troy had opposed the FDA on three matters � two of which were high-profile, all-out campaigns. In a federal case tried in 1998, Troy had demanded that the FDA allow drugmakers to disseminate articles discussing unapproved, or “off-label,” uses of their medications to doctors. He and partner Bert Rein had taken the case pro bono on behalf of the Washington Legal Foundation and its chief counsel, Richard Samp. “Dan had evinced a philosophical position in the First Amendment,” says Rein, referring to Troy’s articles that argued for expanding corporate free speech rights, “so Rich figured he’d be sympathetic to the argument.” Troy won at trial and says he eventually recouped fees for the firm of a “few hundred thousand dollars.” Troy dealt the FDA another loss on free speech issues and secured an important, controversial precedent when he helped Brown & Williamson Tobacco Corporation beat back the FDA’s attempts to regulate cigarettes. In 1998 a conservative-leaning panel in the U.S. Court of Appeals for the Fourth Circuit said that the country’s regulators cannot judge health and food products by any standard other than what their makers say about the items’ purpose. This was the decision that fashion lens maker Pungi relied on last year when his lawyers tried to limit FDA oversight. PUTATIVELY LESS ACTIVIST Having whipped the FDA on behalf of Big Pharma and Big Tobacco, Troy’s next move was to take over the agency itself. He landed that job after George W. Bush’s 2000 transition team invited him to name several agencies where he would be interested in serving. One of his two top choices was the FDA (he won’t name the other), where he now oversees 70 lawyers. The administration, he says, had decided to convert the chief counsel job back into a political appointment rather than maintain it as a career civil service position � a way for the president to influence activity deeper in the bureaucracy. (Troy’s younger brother, Tevi, author of Intellectuals and the American Presidency, works on labor issues and is Jewish community liaison for the White House.) So far, Troy has been as active in his FDA position as David Kessler was during his recent controversial tenure as commissioner � albeit from a decidedly different point of view. Which is remarkable � because Troy’s position is putatively less activist by definition, and because Kessler was one of the most active FDA commissioners in history. Himself a lawyer, Kessler took over in 1990 after a bribery scandal rocked the agency, and the first Bush administration asked him to rebuild the FDA’s enforcement muscle. Troy entered an agency facing a different, and subtler, level of public criticism. Complaints in the late 1990s had begun focusing on delayed access to medicines, and advocacy groups had started claiming “death by regulation.” Troy was the Bush administration’s first appointee to the FDA. Jane Henney, Kessler’s low-key successor, had not been asked to stay on, and during Troy’s first seven months, he didn’t have even an interim commissioner above him. “He was essentially the one person at the FDA who could speak for the administration during that time,” says Michael McCaughan, executive editor of The Pink Sheet, a weekly newsletter of record for the drug industry. “Later, he was more like a cocommissioner.” One measure of Troy’s activity is how much more speechifying he has done than his predecessor, Margaret Jane Porter. During the 12 years she served, The Pink Sheet and related newsletters mentioned her an average of 5.2 times a year, according to a Nexis search. During his first 22 months, the newsletters named Troy at the rate of 92 times per year. Troy reported directly to the U.S. Department of Health and Human Services general counsel, Alex Azar II, a 36-year-old fellow alumnus of Wiley Rein. (Troy says he didn’t seek this job.) The pair quickly announced management changes. In November 2001 Azar’s HHS colleague, deputy secretary Claude Allen, ordered that Troy’s office review all the letters that the FDA sent out to manufacturers warning them that they were in violation of regulations. Previously, units of the agency issued their own warning letters. This consolidation of power coincided with growing demands. Following September 11, 2001, the agency dedicated increasing resources to the review of vaccines and bioterror antidotes. The agency already was grappling with fast-evolving technologies, such as bioengineered food and combination drug-and-device heart products. And that was just the product half of it. The other half of the FDA’s mission involves reviewing advertisements and promotions. The workload there grew also: Since the late 1990s drugmakers have doubled the number of sales representatives peddling products to doctors, as well as the number of consumer ads, according to market analysts IMS Health Inc. Meanwhile, online medicine sales � ripe for deception � have mushroomed from almost nothing in 1997 to an estimated $1 billion annually as of 2003, according to Jupiter Research, a technology industry analyst. WIN-LOSS RECORD Through it all, Troy has persevered in his antilitigation campaign, an effort that has continued under his new boss. Mark McClellan came over to the agency from the White House, where he was chief of health care issues, 15 months after Troy started. When McClellan announced during his first month that the agency wanted to ease labeling standards to allow food makers to more freely claim health improvements, he noted certain cases where courts had ruled the FDA was “excessively limiting” the consumers’ access to information. Troy says that the agency has lost four high-profile First Amendment cases in a row, and recently other sorts of cases, too. He says this losing streak helped inspire him to take the job: “One of the things I know is how to attack administrative agencies, and I know how to defend administrative agencies. And I continue to believe this is really one of the places that I can try to help the agency, by ensuring that we take positions that we can defend in courts.” Some observers say that Troy is overstating the agency’s courtroom credibility problem. “The FDA is stunningly successful in court compared to other administrative agencies,” says Jerry Mashaw, Yale University professor of law and author of several books on administrative law. The agency’s win-loss record in federal appellate courts since 1990 has been 94�23, according to a study published in August 2002 in the Food and Drug Law Institute Journal. The authors � Erika King and Elizabeth Martell Walsh, then associates at Covington & Burling � wrote that, contrary to their own perception, “the FDA’s loss rate in nonenforcement cases has remained fairly constant for the last two decades.” (Walsh is still an associate at Covington, while King has since joined the legal team of the Pharmaceutical Research and Manufacturers of America.) In general, says Noah Feldman, New York University assistant professor of administrative law, agency counsel can afford to be relatively adventurous because the agency can’t be sued for damages. In addition to the tobacco decision, Troy justifies his stance by pointing to the Federal Communications Commission’s loss of credibility with the courts. “I think that the FCC lost cases that they should have won as a result,” says Troy, who also litigated against that agency while in private practice. But others disagree. “The comparison with the FCC is pretty far-fetched,” says Mashaw, adding, “That skepticism has been developing over several decades.” Even some of Troy’s Republican partisans see the FDA as rarely vulnerable. “The FDA almost never loses on anything that involves the public health,” says Michael Astrue, general counsel of Health and Human Services during the administration of the senior George Bush. Troy has encouraged the regulated parties to negotiate with him before suing the agency. In practice, his invitation has inspired lawyers to discuss concerns about actions taken by one of the agency’s seven product centers before they file a lawsuit � creating an informal appeal process. “If my client can’t get the center or the district to see it our way, I or they may talk to Troy,” says Nancy Buc of Washington, D.C.’s Buc & Beardsley. Her comments are echoed by other Washington lawyers who practice before the FDA, including some at Arnold & Porter, Crowell & Moring, and Manelli Denison & Selter. These lawyers say they’re more valuable to their clients now. Sometimes, Troy says, hearing his opponent’s views in advance allows him to strengthen the agency’s position. He does not take notes of these meetings, though, saying that the meetings do not decide matters but just help him advise the commissioner. As such, any minutes would be attorney work product. This view, however, plays into criticism that he is too sympathetic to industry arguments and could further hurt the FDA’s credibility as an enforcer, says former FDA district director John Scharmann. “If decisions are being made on what industry reps are discussing, then notes ought to be made for the future,” Scharmann says. “It is practice ingrained into any law enforcement agency.” Do Troy’s worries about the FDA’s courtroom credibility justify not regulating new products that are actually used inside the body? For 20 years Applied Digital Solutions, Inc., of Palm Beach, Florida, has manufactured a radio-frequency microchip that allows owners to track lost pets. In May the company was ready to sell a similar device to allow people to find missing children or grandparents who go wandering because of dementia. A medical clinician would use a hypodermic needle to implant such chips in the relative’s loved one. “Getting chipped,” the company calls it. Applied Digital Solutions wanted to resolve its regulatory situation, so the company formally asked the FDA to rule that the agency had no jurisdiction over its product, the VeriChip. Like Fashion Wear, its lawyers (also from Hyman, Phelps) argued that it shouldn’t be regulated because the company hadn’t claimed anything about health. Troy agreed. The product did not fall within the agency’s jurisdiction of products intended “to affect the structure or function of the body,” he wrote in a letter in October 2002 � this despite the fact that to be used the chip must be injected. Troy’s letter deemed the chip a “consumer product,” and thus the responsibility of the Consumer Product Safety Commission � which only regulates products after they hit the market. This relieved Applied Digital Solutions from having to delay the product’s launch, and the company began selling through roving salespeople in so-called ChipMobiles. Troy’s letter didn’t give the company all it had wanted, however. He wrote that if the chip was changed to supply a patient’s health records � helpful if an ambulance crew found the person first � then the FDA would regard it as a “medical device” that couldn’t be sold until the company provided proof of safety. Troy’s seven-page letter, swollen with 20 case citations, has received little notice publicly, but it drew attention inside the agency � for its length, its logic, and the unusual fact that Troy, the agency’s chief counsel, had personally responded. Troy’s reasoning surprised Michael Krawitz, the company’s general counsel. He had expected that the decisive test for the agency would be that VeriChip was an implant. According to spokespeople for the FDA and the Consumer Product Safety Commission, the FDA has regulated all products ever sold for implantation in the human body. By contrast, the agency has not made a practice of regulating other products merely because they happened to provide medical information. “The best example we were focused on was the Medic Alert bracelet,” said Krawitz, noting that such informational jewelry has never been regulated. The VeriChip decision was vintage Troy. As with the noncorrective lenses, he ruled for the primacy of the seller’s word over the customer’s flesh: The FDA couldn’t touch a product � notwithstanding its basic, obvious bodily effects � if the maker didn’t specifically articulate that the product affected a customer’s health. Troy says that he’s just reading the actual language of the food and drug act: “If all implants, per se, were to be regulated by the FDA, you wouldn’t need to go on and qualify ‘implant . . . intended to affect the structure or function of the body of man.’ “ These sorts of decisions are among the reasons that Troy revels in the “intellectual feast” of his job. “The FDA has a very unusual jurisdiction,” he said in an interview this winter in his Rockville, Maryland, office. He paused, and picked up a metal tumbler resting on the table in front of him. “This cup, do we have jurisdiction over this cup?” he asked rhetorically. “No, but if I were to market this same cup to say it will cure your cancer � Boom! We have jurisdiction over it.” Of course, by this logic, if breast implants were sold and marketed on the basis of providing nothing more than aesthetic appeal, the FDA would not have jurisdiction over them. Presented with this hypothetical, Troy responds that there’s no question those implants are medical devices � “they are clearly intended to effectuate permanent physiological change,” a standard endorsed by several courts. Doesn’t the VeriChip change the structure of the arm? “Only,” he replies, “in the most surface way.” There was another twist in the VeriChip story. Applied Digital Solutions, eager to qualify the medical-data version for sale, wrote Troy on November 5, 2002. The company shared its plans to market the device and asked for clarification about what it needed to do to get approval for that purpose. Others at the FDA hadn’t returned the company’s phone calls. Yet instead of replying with suggestions, Troy within 24 hours sent the company a “warning letter.” This prompted press reports that the product was in trouble � which was unsurprising, as such notice usually means the agency will seize inventory or file a lawsuit unless the company ceases its current unlawful sales practices and comes in to settle. “The warning letter is traditionally what someone who is on the market gets because the FDA thinks what they’re doing is not legal,” says Stuart Pape, a Patton Boggs food and drug lawyer. When a company sends a proposal the FDA doesn’t like, “what they usually get is a letter that says, ‘Thank you very much for sharing the plan,’ ” and outlines who to call, adds Pape. Earlier that autumn, trade publications reported that, under Troy’s watch, the number of warning letters dropped 75 percent compared with the year before. Did Troy unfairly seize an opportunity for a token show of strength after he had quietly weakened regulations? Troy defends the chip letter: “We felt that after they had gotten a letter like this, a seven-page letter . . . we couldn’t have been clearer.” Perhaps. But, notwithstanding the apparent toughness on the medical information chip, the locator version is now being injected into children and the elderly nationwide � with no regulation. PRESERVING POWER Sometimes Troy isn’t shy about litigating, even when he’s losing handily. This spring he undertook an aggressive campaign to defend his agency’s power � one that also advances one of this administration’s broadest initiatives: restricting plaintiffs’ options under tort litigation. Troy’s office intervened on behalf of manufacturers in three separate product liability lawsuits. The FDA filed amicus briefs supporting the labeling language of Zoloft (made by former Troy client Pfizer Inc.), Paxil, and a smokeless nicotine product (both made by GlaxoSmithKline). Plaintiffs in each case claimed that the manufacturers had failed to list significant side effects, providing instead only the minimum of warnings that the FDA had required for each. In response, the FDA claimed exclusive control over all drug labels, asking the court to dismiss the plaintiffs’ claims. “Given the intent of Congress to centralize prescription drug advertisement regulation in the FDA, this court should defer to the agency,” it argued in the Paxil case. Previously, the agency had not sought to dismiss private lawsuits over this issue, and many courts have regarded FDA label decisions as minimum standards only. “The FDA has never really taken a position pro-preemption, except with certain specific state regulations,” says Louisiana State University law professor Edward Richards. It’s not clear how Troy’s argument aids the agency’s credibility. Indeed, so far it has been nothing but a courthouse loser. In the Paxil case, federal judge Marianna Pfaelzer in Los Angeles curtly dismissed the FDA’s argument. She noted that the FDA’s 12-page brief contradicted all other available decisions on the issue. The agency’s argument that Congress planned to eliminate the right to sue in state court, while not creating another avenue for private claims, “vitiates, rather than advances, the Food, Drug, and Cosmetic Act’s purpose of protecting the public,” she wrote. Troy says he will keep arguing the point. “I distinguish between taking positions in which we are sued and we lose, and taking offensive positions, where we think we need to vindicate the agency’s authority,” he says. In the Paxil case, Troy even plans to argue the point a second time to Judge Pfaelzer, who ruled against the agency in a preliminary injunction round. “On the surface she rejected the argument, but she didn’t spend a lot of time on it,” he says. At a recent conference, Troy used the drug label issue to once again make like a robust regulator, warning industry lawyers about the power of the FDA. The agency was planning to use its authority to require makers of over-the-counter drugs to add new warnings to their labels. Troy announced that the FDA need not have proof that the drug caused trouble to require warnings. Protecting the public meant that the agency would act first if it thought the public was in danger. Once again, however, Troy followed his zig with a zag. In the final version of the rule, he announced, drugmakers would find extra legal protection: The regulation would include a disclaimer that an agency warning should not be viewed as a finding of causation of harm. This statement likely would help manufacturers in product liability cases. It wouldn’t appear on labels, but putting it in the Federal Register could help defense lawyers get cases against drugmakers thrown out. Whether the subject is medicine or law, it seems, Dan Troy finds some side effects more troubling than others.
This article originally appeared in The American Lawyer, a Corporate Counsel sibling publication.

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