Double-Crossing to Safety

...Congress had just passed the Nutrition Labeling and Education Act, and the FDA would later issue over 4,000 pages of regulations and commentary on the new rules...

...He wanted major attention from the press, and he was going to get it...

...The American Spectator January 1995 25 decades...

...t7l The American Spectator January 1995 29...

...From mid-1992 to early 1994, the backlog of requests for minor improvement modifications of existing medical devices increased from only twelve applications to over a thousand...

...Vitamin Villains Rep...

...Martin's Press...

...Since then, Kessler, himself a former pipe-smoker, has made false accusations while keeping the press in a frenzy over allegations...

...Kessler has overseen an unprecedented expansion of regulatory interference and meddling by the agency...

...Never has there been a systematic evaluation of vitamins...

...Even during the campaign, he tried to schedule dinner with Al Gore...

...The complaints are well-founded...

...The mention of the off-label use in the textbook supposedly makes all the drugs "misbranded"—and thus unsafe for the public...

...More than 100 million Americans currently take dietary supplements to bolster diets, enhance "wellbeing," or combat illness...

...It has confiscated millions of dollars of inventory from phannaceutical and other companies, and destroyed thousands of private-sector jobs...

...But as Kessler expanded the reach of the FDA, he had far more on his mind than merely the labels on orange juice cartons...

...Just as it did with Citrus Hill orange juice, the FDA is also confiscating extraordinary quantities of vitamins and dietary supplements...

...Kessler, however, wasco actually had only average nicotine levels...

...Whereas in Germany it would require four months and $10,000 to get a new medical device approved, the FDA requires four years and $8 million, according to one medical executive...

...Kessler is eager to collect information on dietary supplement products currently on the market and the claims being made for them...

...The marketplace is awash in unsubstantiated claims...

...Maybe not, but there was nothing unsafe about the orange juice at all...

...In 1989, the FDA approved fifty-nine new breakthrough medical devices...

...But Kessler had already been so adamant about keeping the post that, after Bush ordered all political appointees to submit their resignations, he refused...

...Kessler then took sweeping action: He ordered U.S...

...Consequently, we are requesting the district offices to conduct an undercover survey of dietary supplements...

...It is time to do what needs to be done...

...employees because of FDA delays, 29 percent increased their investment in foreign operations, and 22 percent moved U.S...

...Remarkably, Kessler and friends are reportedly discussing the possibility of his running for president...

...there are now more exThe seizure was purely a political ploy for power, which is why Kessler timed the raid to coincide with a speech he was giving in Florida at the annual convention of the food-and-drug lawyers...

...According to Kim Pearson, a colleague of Kessler's on the Senate Labor and Human Resources Committee in the early 1980s and publisher of Food and Drug Insider Report, "Several companies have abandoned plans to include the most up-to-date drug use information disclosed by medical journals for fear that the FDA will restrict distribution of their texts in retaliation...

...On May 6, 1992, a platoon of sixteen FDA inspectors and local police in flak jackets carried out a no-knock raid, smashing in the door of the Tahoma Clinic in Kent, Washington...

...A survey by the American Electronics Association found that "40 percent[of device companies] reduced the number of U.S...

...Those delays have meant thousands of deaths...

...Kessler told a congressional hearing the following month that since manufacturers have the technology to remove nicotine from cigarettes, the fact that cigarettes have any nicotine at all might prove that manufacturers intend to addict smokers...

...As Kessler later told the New York Times Magazine: "The law says that a false and misleading claim adulterates the food...

...The panel held two days of meetings in early August...

...Over 40 million adults have quit smoking in recent decades...

...The FDA has strangled the free exchange of information about new and innovative uses for medicines...

...When Bush received Clinton's list, he agreed not to accept Kessler's resignation—compounding the original mistake of hiring him in the first place...

...Chicago lawyer Robert Pristave observed that the FDA's approval process for major new medical devices "has become so laborious that leading FDA legal specialists are now regularly advising their device manufacturing clients to manufacture and sell their products only outside the U.S...

...The hearing was to be televised, and to prepare for the publicity barrage, the FDA sent an unusual, "not for public distributiop" memorandum—dated July 8—to all of its district offices, which began as follows: In preparation for Congressman Waxman's July 29, 1993, hearing on dietary supplements, Dr...

...Pharmaceutical companies have routinely publicized the results of further research on their drugs after FDA approval, thereby Cancer newsletters have been shut down...

...in 1992, it approved only twelve such devices...

...Kessler ordered the FDA's Drug Abuse Advisory Committee to meet and decide whether nicotine is addictive...

...The FDA has now decreed that when a drug company gives free textbooks to doctors that mention an off-label use of that company's products, the FDA can confiscate all of the drugs...

...One of the clearest test cases of whether a Republican Congress can begin to rein in big government will be the forthcoming battle over the future of the FDA...

...Pharmaceutical companies often distribute free copies of textbooks to physicians, both as a courtesy and a sales device...

...Cigarettes, he declared, may simply be "high-tech drug delivery devices...

...ABC's Peter Jennings gushed that Kessler "is an activist, no doubt, in a job which has often been burdened by bureaucrats...

...More incredibly, the FDA in many cases will ban the export of medical devices made in the U.S...

...they even tore the phones out of the wall...

...He even boasted about creating a new Office of Criminal Investigations, and observed, "We rely much less on voluntary agreements, and much more on court-enforceable consent decrees...

...the testimony was so stacked in favor of Kessler's position that the tobacco industry was given only one hour to argue...

...Press conferences announcing new applications (usually from controlled clinical trials) are for the most part eliminated...

...In 1991, he prohibited pharmaceutical companies from informing doctors of new uses for approved drugs, and indicated that the FDA would enforce the ban with seizures, injunctions, and prosecutions...

...Newsletters, books, and television programs that disseminated the latest in treatments and therapies have been stifled or closed down...

...hiring...

...David Kessler at the Food and Drug Administration has been marked by hunger for regulations and addiction to power...

...The device...

...Kessler had declared in June, "Everyone knows that cigarettes are not good for you...

...A survey last summer by the Minneapolis Star-Tribune found that Minnesota firms planned to create 1,700 jobs in foreign countries during the next five years—largely because of FDA delays in approving medical devices stateside...

...The Washington Times derided the process as a "hastily organized show trial...

...In late 1993, the FDA issued 26 The American Spectator January 1995 regulations that prevented vitamin producers from making any health benefit claims for their products...

...Tufts also found that most of the new drugs that the FDA approved were already on the shelves in foreign countries by the time the FDA made them available to Americans...

...Orrin Hatch's staff was less kind: "This false and misleading document is so riddled with inaccuracies that it lacks any evidentiary value, andraises serious questions about the motives of those who are responsible for its preparation...

...Pharmaceutical manufacturers must get FDA approval for each recommended use of their drug, but researchers often discover that a drug is effective at treating other types of disease than the ones for which it was originally developed...

...With medicines, David Kessler's FDA is doing something far worse: It is costing Americans their lives.alerting physicians to other possible ways to save lives...

...The FDA is thus issuing regulations that impede the public's right to know which substances might make them healthier and stronger...

...Kessler is in many ways an archetype of Washington in the Bush-Clinton years, a perfect example of the blind faith in government power and the contempt for private ingenuity that has permeated the last two administrations...

...He conducts himself as the people's guardian in matters of food and drugs with the utmost conviction...

...Yet the consensus in the scientific community on the benefits of vitamins—based on hundreds of articles in medical journals—has become stronger than ever...

...But Kessler has waged war on the dissemination of information about off-label uses of drugs...

...The raiders seized more than $100,000 in products and office supplies—including address books and diaries—and spent 14 hours cleaning out the office...

...Weeks later, associate FDA Commissioner Jeff Nesbitt announced, "The agency expects any and every company to make sure that its labeling is consistent with FDA policy, which has been in place for several A month after Clinton won the 1992 election, Kessler cited the increase in FDA regulations on his watch during a speech in Washington that was an open audition for the Clinton administration...

...FDA compliance officer Darryl Thompson claimed the machines come under the agency's purview because they are intended to "affect the structure or function" of users, and that since the company did not gain FDA approval, its machines were automatically—like food—"adulterated...

...While Kessler was denouncing the supplements industry for deceptive practices, he himself was pulling off a scam of enormous proportions...

...Kessler had retained control of his powerful fiefdom, and `fresh' on food labels," and requesting "that industry not make use of this term pending adoption of a final rule on this subject...

...The percentage of Americans who smoke has fallen sharply since the Surgeon General's landmark 1964 report on the dangers of smoking...

...just a simple change in labeling requirements could cost a company its entire system of brand-name identification...

...thus we have the bizarre spectacle of one federal agency prohibiting the dissemination of another agency's research...

...Kessler's report claimed the products "all have one thing in common: Not one of the claims has been substantiated by the FDA before their appearance in the marketplace...

...One former high-ranking FDA official observed that he thought Kessler has always acted like he is planning to run for the Senate...

...If the texts have too much information on off-label use for the FDA's taste, the publisher could lose one of the most lucrative outlets for its books...

...The media hailed Kessler anyway...

...Kessler gravely concluded that these facts "lay to rest any notion that there is no manipulation and control of nicotine...

...In fact, according to a study by Duke professor Kip Viscusi, smokers significantly overestimate their chances of dying from cigarettes: While almost half of the surveyed smokers said they expect to die from the lung, throat, or heart problems caused by smoking, the surgeon general in 1991 estimated that only 18-36 percent of smokers would die as a result of smoking...

...Newt Gingrich has denounced the FDA as "the leading job killer in America," and floated a plan to replace it within five years with an agency staffed with biomedical entrepreneurs, James Bovard is the author of Lost Rights: The Destruction of American Liberty (St...

...The report concluded, "Many of the small companies that populate the industry may be driven out of business altogether by regulatory delays...

...A throng of humanity stood in front of the building, as if milling about after a fire drill...

...When the panel voted nicotine was indeed addictive, Kessler publicly announced: "This was a very significant finding...

...Congress passed an act in October to rein in the FDA's oversight of the vitamin industry, but, as attorney Jonathan Emord observes, the new law is full of vague phrases that could be invoked to expand the agency's arbitrary power...

...They held the staff at gunpoint, ostensibly so that nobody could try to hide the vitamins...

...The FDA has knowingly submitted false information to Congress and it has willfully violated the presumption of accuracy and impartiality traditionally granted the agency...

...jobs overseas...

...That meant that Clinton would not have to renominate the commissioner, thereby averting a bloody confirmation hearing at the hands of Republicans irate over what one called "disloyal, traitorous" conduct...

...Kessler rushed to accuse the cigarette manufacturers of misconduct to avoid being beaten to the punch by a tabloid news program...

...Kessler reportedly wouldn't sign the form letter sent to him for that purpose until a special White House courier was sent to his office to pick it up...

...Since Kessler has been here," says one high-ranking FDA staffer, "we are turning out regulations faster than ever before...

...Under the present administration, the FDA's actions have been arbitrary and unpredictable, and it has become virtually impossible to bring a new medical product to the public...

...A leading support group for cancer patients has strongly objected that the new policy will keep patients from receiving the best therapies...

...The FDA has also been suppressing the sale and distribuThe American Spectator January 1995 27 tion of medical textbooks to enforce its ban on information it does not want disseminated...

...Last June 14, agents swooped down on the headquarters of the Seattle-based Synetic Systems to seize a device the agency thought posed serious risks to the American people...

...Instead, he did the opposite: He twisted federal law to dramatically increase the FDA's power and dramatically expand its bureaucracy...

...The FDA prohibition on mentioning new uses of approved drugs effectively turns back the clock five years on the advancement of medical science, and imposes a "cost of truth" test that requires spending millions of dollars and the loss of countless lives...

...0 ver the crest of the hill on Fishers Lane in suburban Rockville, Maryland, there it was: the 18-story, ugly-enoughfor-government-work building that houses perhaps the most powerful regulatory agency on earth...

...the company also pointed to consumer surveys that showed people did not think "Fresh Choice" meant fresh-squeezed...

...The "Sharper Image Relaxation System" machine...

...Since the Federal Trade Commission regulates and mandates that nicotine levels be published on cigarette packs, manufacturers cannot use new types of tobacco to covertly turn smokers into helpless zombies...

...Henry Waxman, chairman of the House Subcommittee on Health and the Environment and a longtime Kessler confidant, was holding a hearing on dietary supplements on July 29, 1993...

...FDA agents were supposedly concerned about the clinic's use of injected 13-vitamins, which have been widely used in Germany with no adverse health problems...

...The FDA review time for major new medical devices has increased from 337 days in 1988 to almost 800 days now, according to the Biomedical Market Newsletter...

...not about to let truth interfere with his assault on the tobacco industry...

...He began the speech by articulating his aspirations for the agency: "To restore the FDA to its former position of preeminence in matters involving food...

...He waved a 105-page report before the cameras that his staff had written on the supposed crimes of the industry...

...Oncologists have declared that patients will die because physicians will not learn of efficacious treatments...

...Research at the National Heart, Lung and Blood Institute is federally funded...

...Kessler used the information provided by ABC to scoop the network, announcing the next day—three days before the show aired—that he was launching an investigation into whether tobacco companies were manipulating nicotine in cigarettes...

...Indeed, says Schwarz, "In some cases, if you didn't use the drugs in the off-label way, you'd be guilty of malpractice...

...The New York Times printed Kessler's allegations on its front page—and then, the following day, printed a highly publicized correction admitting a stunning error...

...It is a clear answer to the tobacco industry rhetoric about freedom of choice...

...Of the report's list of 528 products with unsubstantiated claims of health benefits, 142 were not manufactured, sold, or distributed by the company to which the FDA attributed them...

...Kessler is seeking to portray greatly increased restrictions over tobacco as the equivalent of a war to free the slaves...

...even when a foreign government has already approved the device—simply because the FDA has not given its approval...

...Thirty-four of the "products" did not even exist...

...Meanwhile, the number of FDA employees assigned full time to regulating the vitamin and supplement industry has increased fourfold since 1992...

...Each district office was required to assign three inspectors to make six site visits to local health-food stores...

...Disabling Medical Devices Kessler's FDA has further retarded the progress of treatments by drastically increasing the approval times for medical devices—a category that includes such products as mint-flavored dental floss and wheelchair cushions...

...Synetic surrendered to the FDA because it could not afford to spend hundreds of thousands of dollars fighting the federal government in court...

...In his statement of February 25—a letter to the group Coalition on Smoking or Health—Kessler announced, "It is our understanding that manufacturers commonly add nicotine to cigarettes to deliver specific amounts of nicotine," and accused cigarette manufacturers of putting nicotine in cigarettes "to satisfy an addiction on the part of some of their customers...

...And while patients die because they cannot gain access to potentially life-saving drugs, the FDA is devoting its resources instead to cracking down on drugs already on the market...

...It has "knowingly submitted false information to Congress," according to an investigation of the agency by the staff of Sen...

...The crime...

...With regulatory confusion in the air, Kessler's get-tough policy couldn't fail to strike terror in the boardrooms of food companies nationwide...

...An evaluation of the report by Sen...

...Doubling the amount of nicotine in a type of tobacco simply allows a manufacturer to blend the high-nicotine tobacco with lower-nicotine tobacco to achieve any desired level of nicotine per cigarette...

...According to the New England Journal of Medicine, however, the average level of nicotine in cigarettes has fallen by more than 50 percent since 1955...

...Watch Out, Arlen Specter At staff meetings, Kessler has recently cultivated the egotist's habit of referring to himself in the third person, in sentences like, "The Commissioner of the Food and Drug Administration cannot tell the American people that the government will not help them...

...In fact, doctors can call the Food and Drug Administration toll-free to inform on companies giving out such information...

...According to the FDA's interpretation of its own rules, if an employee makes a claim about a product, the product is automatically "mislabeled"—and thus subject to confiscation...

...One of the offending items was a paperback book...

...Federal law declares that a "misbranded" or "mislabeled" product is automatically unsafe, and provides FDA with the authority to confiscate the merchandise...

...Medical textbooks often discuss the latest developments in pharmaceutical use, including uses not yet ordained by the FDA...

...Makers of a reconstituted juice called Citrus Hill Fresh Choice, Procter & Gamble responded by filing a request for an "urgent FDA rulemaking," arguing that there were currently seventy-nine different uses of the word "fresh" by food processors...

...The level of nicotine in cigarettes is significantly lower than it is in natural tobacco...

...Only up close did it become clear that they were actually engaging in an activity frowned upon by the building's higher-ups, sucking on cigarettes as a wino pulls on his last slug of Ripple...

...A former agency official describes him as a "zealot," but zealotry seems a weak term for the intrusive and deadly bureaucracy of Kessler's FDA...

...Kazman surmises that twenty-two thousand may have died while the FDA approved streptokinase, which dissolves blood clots in heart-attack victims...

...And if they don't, and if the FDA finds out about it, then those companies can expect similar action...

...Kessler thundered: "We are slipping back to the turn of the century, when snake-oil salesmen roamed about...

...The pettiness of some FDA enforcement efforts is nearly incomprehensible...

...Either way, it would be out of character for Kessler to seek people's permission to represent them...

...Kessler demurred, while his staff repeatedly requested to see what evidence the tabloid program had gathered...

...This was blatant disingenuousness: The FDA refuses to accept practically any of the evidence of medical journals, clinical studies, and other valid sources on the benefits of vitamins and supplements...

...Thus, because the FDA refused to approve the private companies' claims, Kessler declared they must ail be presumed to be liars...

...Procter & Gamble lawyers argued that their client's labeling was not misleading because "Made from Concentrate" was also on the label...

...a month after Clinton won the 1992 election, Kessler cited the increase in FDA regulations on his watch during a speech in Washington that was an open audition for the Clinton administration...

...We're getting new regulations out faster than ever before...

...In June, Kessler returned to Capitol Hill and accused the Brown & Williamson Tobacco Company—makers of Kool, Viceroy, and Raleigh—of secretly and deviously creating a type of tobacco in Brazil with double the normal nicotine amount in order to make its cigarettes more addictive...

...A 1988 study showed that the risk of heart attacks for males over 50 was reduced by 50 percent by taking an aspirin each day...

...It's a fitting welcome to the fiefdom of Food and Drug Administration Commissioner David Kessler, Washington's most powerful bureaucratic czar, with regulatory control over a trillion dollars worth of the nation's GNP and an agenda that would criminalize everything from the manufacture of shower commode chairs to the voluntary use of dread tobacco...

...In fact, the rules for the labeling of food products were more in flux than ever before...

...The commissioner had been actively campaigning to keep his job for months, "working furiously behind the scenes," as a Bush official told Forbes...

...Such rule changes often take a decade or more, and the FDA's request would have required every food company that used "fresh" on its labels to abandon its labeling immediately—in other words, to take a suicide leap off the shelves of America's grocery stores...

...It was a final bit of phony bluster for the cameras—in fact, the FDA has not acted on even one of the 528 alleged false claims in the report...

...Freedom of choice," said Kessler, "means little unless consumers have meaningful and accurate information on safety and effectiveness in deciding whether to purchase these products...

...The rationale...

...The process also means that Americans are denied health-care options that could be safer, more effective or less costly than those on the market today...

...When Clinton sent the White House the names of a handful of Bush appointees he wished to retain, Kessler was on the list...

...A recent study by Tufts University found that it took an average of almost nine years for new drugs to receive final approval...

...I am here today to talk about change," he crowed, "and while the national dialogue for change has been in vogue during this election year, it is fair to say that on this one the Food and Drug Administration has been ahead of the curve...

...Perhaps most importantly, the FDA's tactics are intimidating textbook publishers, who fear that including the latest information on drug uses may result in the FDA restricting sales of their books...

...James Clyburn observed a few weeks later, "It appears that Dr...

...Hatch staffers examined the actual reports of the undercover agents and discovered that Kessler had grossly misrepresented many of the incidents...

...Late last year, the ABC News tabloid newsmagazine "Day One" began contacting Kessler to make comments for a program they were preparing accusing tobacco companies of manipulating the nicotine level in cigarettes to addict smokers...

...Brown & Williamson blended the new tobacco type with other tobacco parts to create a normal-nicotine-level cigarette...

...Christopher Conway, CEO of a California medical device firm, observed: "We are no longer surprised at anything the FDA does...

...marshals to seize the juice-12,000 gallons, as it turned out—and destroy it...

...Here's why he's about to become the Republicans' juiciest target...

...In July 1989, however, the FDA forbade manufacturers from advertising the benefits, on the grounds that aspirin was not labeled as heart medicine...

...By enforcing arcane regulations about alternate uses of already-approved drugs, the FDA has stifled free access to information about other uses of available medicines...

...Orrin Hatch...

...The report he waved for the benefit of his audience was a hastily cobbled together prop that was, to be generous, slipshod and marred with errors...

...And they are more intrusive than ever before...

...In early 1991, the FDA threatened Procter & Gamble on the grounds that the company might be guilty of misleading consumers with its use of the word "fresh...

...It has set grim records with its absurd delays of the approvals for new medical devices...

...At the subcommittee hearing, Kessler claimed that health-food stores routinely made outlandish statements about their products...

...But Gingrich is surely in for a hell of a fight...

...Kessler was tapped for the agency by President Bush, largely to unsnarl a bureaucratic labyrinth that was delaying the approval of new drugs...

...When Kessler's staff heard a rumor that the program was about to air, an FDA staffer called ABC to verify the air date, baiting them with the possibility that Kessler might finally do the interview...

...Though the FDA claimed that Dr...

...More than two years later, the FDA has yet to return any of the office records or other material it seized from Wright...

...28 The American Spectator January 1995 On Thursday, February 24, 1994, ABC confirmed that the program—with its headline-making accusations—would air the following Monday...

...The survey also found that Minnesota medical-device firms in recent years have increased their foreign hiring almost three times faster than their U.S...

...FDA undercover agents went into the stores and baited employees into making health claims about products in the store...

...the seizure was purely a political ploy for power, which is why Kessler timed the raid to coincide with a speech he was giving in Florida at the annual convention of food-and-drug lawyers...

...Orange Crush Shortly after taking power, Kessler discovered an excellent means of toughening the agency's image—and turning himself into an anti-capitalist folk hero...

...But that's just vitamins...

...not career bureaucrats...

...FDA officials retorted that it should have been in larger print...

...Kessler Saves His Skin Power, rather than safer and better foods and medicines, 24 The American Spectator January 1995 seems to have been David Kessler's chief concern ever since arriving at the FDA in 1990...

...The Food and Drug Administration under David Kessler has become a self-perpetuating bureaucracy that, in an effort to protect its own prerogatives, costs the lives of people it is supposed to protect...

...The FDA considers the machine so dangerous that it placed the machine in the same category as heart pacemakers—even though there have been no injuries reported from its use...

...I don't need anything more than that...

...Kicking the Habit When It's Down Kessler's most celebrated grab for power came during recent controversy surrounding the tobacco industry...

...In several cases, a health-food clerk's handing an undercover agent a reference book that described a certain product was characterized as a "false claim...

...According to the British Medical Journal, wider publicity of the "aspirin-a-day" preventative medicine practice could save ten thousand American lives each year...

...In 1991, researchers at the National Heart, Lung and Blood Institute reported that Vasotec, a hypertension drug made by Merck & Co., sharply cut the number of cardiovascular deaths in people suffering from chronic congestive heart failure, and curbed heart failure among people with damaged hearts...

...But I'm not sure that everybody really understands how bad they really are...

...The cigarettes that Kessler accused Brown & Williamson of making with the super-high nicotine tobacsmokers than smokers in the U.S...

...These findings are written up in medical journals, newsletters, and other publications...

...Symposiums have nearly been brought to a halt...

...Due to the sensitive nature of the subject the assignment should not be discussed outside of the office...

...Sam Kazman of the Competitive Enterprise Institute estimates that as many as fifteen thousand people died during the FDA's review of misoprostol, which reduces gastric ulcers...

...But his attack is based largely on a gross exaggeration of the_ power of cigarettes...

...American Medical Association Vice President Roy Schwarz estimates that "off-label" uses of drugs may constitute up to 60 percent of all drug prescriptions...

...Kessler—who refused many requests for an interview for this article—would not have disagreed...

...Kessler's speech, given at the annual Food and Drug Law Institute conference,soon enough was playing Hillary Clinton's tune by denouncing the greed of the pharmaceutical companies—even while she was selling them short on the New York Stock Exchange...

...A June 1993 congressional report noted that forty-nine American-made medical devices bogged down in FDA review have already been approved for sale in Europe, Japan, and other countries...

...But, as Business Week noted, Merck's sales force "couldn't give doctors copies of published studies about the new research or similar earlier studies...

...after his error-filled testimony, ABC World News Tonight named Kessler the "Person of the Week...

...Kessler's FDA responded with a Federal Register notice announcing that it was "reviewing the statements that it has made on the use of the term was as overtly political as possible, even blatantly co-opting the rhetoric of the president-elect...

...Jonathan Wright—the founder of the clinic and a highly visible critic of the agency—was engaged in dangerous health practices, it has not filed any charges against him in court...

...The results, as former FTC official John Calfee noted, were these: No New Pills For almost twenty years, pharmaceutical manufacturers, consumer advocates, and policy wonks have been complaining about the FDA's unconscionable delays in approving life-saving new drugs...