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FDA VIOLATION OF THE RULE OF LAW [1]

By Jonathan W. Emord


Many thanks to the Richmond Health Freedom Expo for inviting me to speak and to the Talk Star Radio Network for broadcasting and webcasting this presentation live over that network. Today we discuss the Food and Drug Administration's violations of the rule of law.


The FDA is an executive branch agency, the beneficiary of vast legislative powers delegated to it by Congress. It is also the repository of powers not delegated by Congress that FDA has usurped beyond the limits of its enabling statute throughout its 68 year history. The Commissioner of FDA sits at the pleasure of the President. The FDA is one of the largest and most powerful federal bureaucracies. It regulates over $1 trillion dollars of goods. The products under its jurisdiction account for 25 cents of every dollar spent by American consumers. FDA has approximately ten thousand employees and 26 district offices across the United States. The United States Attorneys and federal marshals are at its disposal and can obtain search and seizure warrants to be exercised without any advance notice against any company that sells a food, dietary supplement, drug, or medical device in the United States.


To understand how FDA has acquired so much power in a government designedly of limited powers, we have to appreciate the agency's place in history. Indeed, we have to start with the origins of American constitutional government, 151 years before the FDA came into existence, to appreciate the perversion of the Framers' plan effected by the modern FDA. We must follow America's late 18th Century rejection of the arbitrary will of King George III, its embrace of a written Constitution where the law and a system of separation of powers and checks and balances were supposed to prevent the accumulation of tyrannical power in any one set of hands. We must then observe the rise of independent regulatory commissions in the Twentieth Century and how those commissions united legislative, executive, and judicial powers into single hands in violation of our founding principles. We must then come to see how FDA in particular exemplifies the arbitrary rule of people in power over the rule of law.


The Framers of our Constitution prohibited the federal government from delegating legislative power from the duly elected representatives of Congress to any other entity. They warned that if legislative power were combined with executive power, or if legislative power were combined with judicial power, our republic would become an oligarchy and the rights of the people would be sacrificed to achieve the selfish ends of those who govern.


In February of 1776, a pamphlet came to be published in Philadelphia that would outsell every other up to that time in the American colonies and would achieve resounding popularity throughout Europe. It was Common Sense. Written anonymously by Thomas Paine, that pamphlet became the most influential tract in revolutionary America. In it Paine explained the quintessential defining principle of our polity, the very reason why we could not endure the arbitrary will of King George III and would rebel to form a new nation. He begged for revolution against Great Britain because the King had usurped rights and powers of the people and had replaced the rule of law with his arbitrary will. Paine wrote:


But where . . . is the King of America? I'll tell you Friend, he reigns above, and doth not make havoc of mankind like the Royal Brute of Britain. Yet that we may not appear to be defective in earthly honors, let a day be solemnly set apart for proclaiming the charter . . . . that in America the law is King. For as in absolute governments the King is law, so in free countries the law ought to be King; and there ought to be no other.


The defining principle of the American republic was that governments are instituted among men to protect the rights of the governed, that to accomplish that task governmental powers must be limited and defined in written law and separated in the hands of independent legislative, executive, and judicial departments with a system of checks and balances to prevent the accumulation of the separate powers into any single department. The French philosopher Montesquieu argued for the separation of powers in his 1748 treatise The Spirit of the Laws. That book greatly influenced the founding fathers, as did endorsements of the doctrine by John Locke and other British Whig writers of the 18th Century. Historian Forrest McDonald explains that all leading politicos of the Founding Era "could recite central points of Montesquieu's doctrine of separation of powers as if it had been a catechism." In The Spirit of the Laws Montesquieu wrote:


[T]here is no liberty if the power of judging be not separated from the legislative and executive powers. Were it joined with the legislative, the life and liberty of the subject would be exposed to arbitrary control, for the judge would then be the legislator. Were it joined to the executive power, the judge might behave with all the violence of an oppressor . . . . There would be an end of everything were the same man, or the same body . . . to exercise those three powers . . . of enacting laws . . . of executing [laws]. . . and . . . of judging the crimes or differences of individuals . . . .


In Federalist No. 47, James Madison argued for the rule of law over the arbitrary will of those in power, explaining that our Constitution would define "a government of laws and not of men." The phrase, common among the founding generation, meant that there was to be no place in government for the exercise of arbitrary will over the lives, liberties, or properties of the American people. Just as we were to be ruled by laws, our law itself was to be the product of separate, competing legislative, executive, and judicial power centers; never were any two of those powers to be combined in a single center. Madison wrote, "[t]he accumulation of all powers, legislative, executive, and judicial, in the same hands, whether of one, few, or many, and whether hereditary, self-appointed, or elected, may justly be pronounced the very definition of tyranny." Typical of the Federalists who advocated ratification of the Constitution, Alexander Hamilton explained that the separation of powers was "itself, in every rational sense, and to every useful purpose, A BILL OF RIGHTS." It would deny a single department autonomous governance. It would keep abuse of power in check by humbling those in government with the need to satisfy the dictates of competing power centers.


Like Montesquieu, the Framers viewed political liberty as a condition in which citizens are free from arbitrary power and can expect to be secure in their persons and property. As Montesquieu put it in The Spirit of the Laws, "[t]he political liberty of the subject is a tranquility of mind, arising from the opinion each person has of his safety." Concentration of two or more of the three classes of power--legislative, executive, judicial--in a single organ of government would destroy that tranquility for reasons that John Adams expressed succinctly in a pamphlet published in 1776: "Because a single assembly, possessed of all the powers of government, would make arbitrary laws for their own interest, execute all laws arbitrarily for their own interest, and adjudge all controversies in their own favor."


Indeed, liberty depends on the secure knowledge that the rule of law governs over the arbitrary will of those in power. The separation of powers assures that no single power center may create, execute, and judge the law but must obtain the consent of the other, independent power centers to achieve those ends. When the separation of powers and the system of checks and balances is gone, so is the security needed for the preservation of liberty from the arbitrary will of those in government.


From 1787 until 1937, the constitutional law of this country prohibited administrators from possessing combined legislative, executive, and judicial powers, but for the last 69 years, the Separation of Powers doctrine has been largely abandoned in favor of oligarchic rule by the independent regulatory commissions. That rule has produced rights violations, massive transfers of wealth from private to public hands, government protectionism for industry leaders over new market entrants, vast corruption, and explosive growth in the size and scope of the federal government. The independent regulatory commissions, and the FDA in particular, are destroying free enterprise and individual liberty in America.


So what happened in 1937 to undue the Framers' constitutional design, the separation of powers doctrine?


Accepting the Republican nomination for President in 1928, Herbert Hoover with great exuberance and confidence predicted, "We in America today are nearer to the final triumph over poverty than ever before in the history of any land. The poorhouse is vanishing from us." Eight months later, on October 29, 1929, the stock market crashed signaling the start of the Great Depression, an economic collapse that reverberated worldwide. From 1929 to 1933, the United States gross national product declined from $104 billion to $56 billion. By 1933, unemployment reached 33% (roughly 16 million Americans out of work). President Hoover lost his re-election bid to Franklin Delano Roosevelt on Roosevelt's promise of a New Deal to end widespread poverty through government largesse.


Shortly after his inauguration in March of 1933, President Roosevelt proposed laws that granted sweeping legislative, executive, and judicial powers to new executive branch agencies. Although the Supreme Court upheld many of these laws, it refused to do so in the 1935 A.L.A. Schechter Poultry Corp. v. U.S. decision. Schechter Poultry struck down Roosevelt's National Industrial Recovery Act of 1933. A unanimous Court held that Title I of the NIRA constituted an "unconstitutional delegation of legislative power to the executive." Chief Justice Charles Evans Hughes wrote for the Court: "Congress is not permitted to abdicate or to transfer to others the essential legislative function with which it is thus vested." In a concurrence, Justice Benjamin Cardozo referred to the industrial code provisions of the NIRA as "delegation [of power] running riot." The Court thus demanded adherence to the separation of powers doctrine embodied in the Constitution.


The Court's actions did not sit well with President Roosevelt. Following his re-election to office and preceding his plans for the enactment of additional executive branch agencies invested with legislative, executive, and judicial powers, President Roosevelt proposed the Judiciary Reorganization Act of 1937. The Act would give President Roosevelt the power to appoint an extra Supreme Court Justice for every sitting Justice over the age of 70 and six months. Six of the Justices on the High Court were over 70 and six months. The Justices predisposed against delegation had held a slim one vote majority (5 to 4). Roosevelt's threatened court packing plan never was enacted but the threat alone provoked the desired response. It produced what the media of that day referred to as "the switch in time that saved nine." Justice Owen J. Roberts who favored the conservative wing of the Court (the so-called Four Horsemen, Justices James Clark McReynolds; George Sutherland; Willis Van DeVanter; and Pierce Butler) voted with the liberal wing of the Court (the so-called Three Musketeers, Justices Louis Brandeis; Benjamin Cardozo; and Harlan Stone). Within a year, conservative Justices Van DeVanter and Sutherland retired, replaced by the pro-New Deal Justices Hugo Black and Stanley Reed.


That shift in the Court's alignment led to the near total erosion of the separation of powers doctrine, resulting in massive legislative delegations of power to independent regulatory commissions, among them the U.S. Food and Drug Administration.


Over the years independent regulatory commissions have not only come to exercise powers intended to be vested in Congress but they have also become legislatures themselves--promulgating regulations that exceed statutory limits and running roughshod over individual liberties designedly protected by the Bill of Rights. The rule of law has been replaced by the arbitrary will of unelected and unaccountable federal bureaucrats. The FDA is an excellent case in point.


Congressional delegations of legislative power to FDA, and FDA usurpations of power, often occur following either a real or supposed public health crisis involving a regulated product.


Federal drug regulation was of trifling import until 1937. In that year an attempt by the Massengill Company to reformulate a sulfa drug into a liquid form resulted in the deaths of 107 children. The company sold the liquid drug in a syrup that included diethylene glycol as a solvent. That is anti-freeze. Although Massengill was convicted of gross negligence, the Roosevelt administration, feeling its oats after the "switch in time that saved nine," called for adoption of the Food, Drug and Cosmetic Act of 1938. That law required companies to submit New Drug Applications (NDA's) before introducing new pharmaceuticals into interstate commerce. In concessions to the leading drug makers, the law grandfathered as lawful all drugs then on the market and created costly safety testing barriers to entry. Each NDA had to document tests that proved a drug safe at recommended dosages. NDAs were automatically approved sixty days after submission unless FDA determined the safety testing insufficient.


Before 1962, FDA regulated drug safety but not drug efficacy. Then in 1961 thousands of deformed newborns began appearing across Europe--victims of the sedative thalidomide. Although existing law included safety reviews that would presumably prevent the sale of thalidomide in the United States, FDA, the pharmaceutical industry, and sympathetic members of Congress argued for expanded FDA powers based on the thalidomide catastrophe. The Kefauver-Harris Drug Amendments became law in 1962. Under the 1938 Act, NDAs were approved unless FDA acted to deny them. Under the 1962 Act, NDAs were denied unless FDA acted to approve them. For an NDA to be granted, FDA had to conclude that the new drug was safe and effective. With the support of the pharmaceutical industry, FDA translated the law into a Byzantine system of clinical trial proofs, not involving product testing by the FDA but involving redundant inquiries and demands for proof at the discretion of agency regulators. The new drug approval process went from a short sixty day to a six month or more review, and the cost from discovery to approval rose from a few million dollars to over $138 million per drug (that cost has now risen to $1.6 billion per drug). The day of the government protected monopolist had arrived for the drug industry.


The 1962 Act also transferred to FDA from FTC jurisdiction over drug advertising--a move urged by the pharmaceutical industry because it lacked the kind of influence over FTC that it had long enjoyed over FDA. The bill codified cGMPs, another barrier to entry into the drug market, and gave FDA expanded inspection powers, yet another barrier. The drug industry lobbied for the bill.


The same year FDA acquired vast new powers to regulate drugs, it tried to expand its drug regulation to eliminate a burgeoning new source of competition for drugs, dietary supplements. Evidence began to reveal that dietary ingredients had therapeutic effects. The far sighted in the pharmaceutical industry and at the FDA perceived a competitive threat emerging to drug regulation from the sale of dietary ingredients at above RDA doses. To counter that threat, and without the slightest grant of legislative authority from Congress, FDA published regulations setting minimum and maximum potency levels for dietary supplements. The regulations were withdrawn in the face of strong public protest.


Four years later, FDA returned to the subject. Again without any grant of legislative authority, FDA published a rule that any dietary supplement exceeding 150% of the RDA for a vitamin or mineral would automatically be regulated as a drug. Once declared a drug, the supplement could not be lawfully marketed in the United States without FDA drug approval. The dietary supplement industry challenged the rule in federal court with mixed results. Public outcry against the rule reached a fever pitch. On April 22, 1976, after intense public lobbying against the rule, Senator William Proxmire introduced an amendment to the Heart and Lung Act and the amended Act became law. It prohibited FDA from classifying a vitamin or a mineral as a drug based on its potency.


Undaunted, FDA tried yet again to rid the market of vitamins in the 1970s by claiming on a case by case basis that they were adulterated based on their potency. The federal courts refused to cooperate with this attempt at an end-run around the Proxmire Amendment. FDA tried another approach in the 1970s. It declared supplements to be unapproved Food Additives. Under the Food Additives provision of the FDCA, no food additive may be sold unless the manufacturer proves it safe to FDA's satisfaction. In this way, FDA planned to make proving the safety of supplements so difficult that it would drive them out of the market. FDA's position was a logical absurdity: Single ingredient dietary supplements were food additives because the ingredients were added to a gelatin capsule which was, FDA said with a wink and a smirk, a food. The federal courts rejected this effort. The United States Court of Appeals for the First Circuit described FDA's approach as "nonsensical." The United States Court of Appeals for the Seventh Circuit described FDA's position as an "Alice in Wonderland" approach.


Then in 1980, FDA was back at it. This time FDA issued a proposed over-the-counter drug monograph for vitamins and minerals, declaring potencies above the RDA to fall within the scope of the monograph. Substantial public opposition killed this proposal.


Most notably from the codification of the Kefauver-Harris Amendments of 1962 to the present, FDA has repeatedly exceeded the limits of its statutory authority to bring about changes designed to protect drug companies from competition. Many times those changes have come at the cost of human life. Courts have occasionally held FDA's actions unlawful. Rarely has FDA respected court decisions against its exercise of authority. The agency's usual course is either to ignore court orders or to render them ineffectual through the adoption of new rules, policies, or approaches that achieve the ends FDA desires through different means. The FDA's lack of respect for the rule of law, its destruction of the rule of law itself, was a consequence predicted by the Framers of the Constitution who warned against delegation of legislative powers.


Since 1962, people within the FDA itself and outside the agency have complained bitterly that FDA is unduly influenced by drug companies. The complaining parties are many, have excellent reputations for honesty, and have spoken against their own economic interests and at considerable personal risk of FDA retaliation. FDA has approved numerous drugs over the objections of its drug safety officers. A significant number of those drugs have been withdrawn from the market following occurrence of the very harms predicted by FDA's drug safety officers. The following drugs are among those FDA allowed Into the market over the objections of its drug safety officers. Each of the drugs was subsequently withdrawn from the market when the predicted harms actually occurred: GlaxoSmithKline's Lotronex for irritable bowel syndrome; American Home Products' Redux, a diet aid; Bayer Corporation's Raxav, an antibiotic; Roche's Posicor, a blood pressure medication; Wyeth-Ayersts' Duract, a painkiller; and Warner-Lambert's Rezulin, a diabetes drug.


In 1987, an FDA supervisor named Charles Chang received expensive gifts (including a fur coat and a videocassette recorder) from drug company lobbyists in exchange for making sure that their drugs were assigned to subordinates Chang knew to be quick reviewers. Through his assignment of work, Chang manipulated the approval schedule to the advantage of those who gave him bribes. Given a tip to investigate the corruption by Barr Laboratories, the Department of Justice and the FBI uncovered corrupt practices within the agency's generic drug division. The sting landed Chang in federal prison and caused 42 others and 10 companies to be convicted on charges of fraud and corruption. The scandal shook congressional confidence in FDA. It brought down the FDA Commissioner Frank Young who resigned in November 1989. Although FDA was clearly in the wrong, senior management at the agency resented Barr Laboratories disclosures to the Justice Department, FBI, and Congress. Commissioner David Kessler authorized repeated inspections of Barr Laboratories' facilities and delayed approvals for its drugs then in the pipeline.


In 1997, the drug Rezulin was approved by FDA for the treatment of Type 2 diabetes over objections from several FDA drug safety officers that Rezulin significantly increased liver enzyme levels and would cause liver failure and death. Complaining that politics ruled over science at the agency, the FDA's drug safety officer Robert Misbin resigned. Frustrated with FDA management for approving Rezulin despite its lethal dangers, Misbin said he knew people would die and did "not want to stay around for what's going to happen." Not willing to sit idly by while the bodies piled up, Misbin complained to Congress. The FDA retaliated by giving Misbin his first negative job performance review and commenced an internal investigation against him. Members of Congress condemned FDA's actions. Misbin was not the first FDA scientist to be persecuted for complaining about Rezulin safety problems. FDA Internal Affairs interrogated Dr. Leo Lutwak, whom they also accused of leaking data on Rezulin. FDA Internal Affairs investigated Dr. John Gueriguian, the original scientist in charge of FDA's review of the Rezulin trials, after he also insisted that Rezulin was too dangerous to be sold. Doctors Gueriguian and Lutwak retired from FDA rather than face the costly investigations. Lutwak told CBS News, "In my own agency I'm treated like...I'm treated worse than a criminal! I'm accused, I'm threatened, I'm taken away from my work." CBS News also reported that two researchers at Warner-Lambert who conducted clinical trials on Rezulin claimed the company told them to downplay problems with the drug. FDA documents showed tests of the drug found liver enzyme levels six times normal, but Warner-Lambert reported levels of "2 to 3 times...normal," a figure the company later acknowledged to be incorrect.


Rezulin was withdrawn from the market after it was associated with 391 deaths, including 63 from liver failure. According to Warner-Lambert records, a senior FDA official, Dr. G. Alexander Fleming, offered to "ease out" any FDA medical officer who exposed doubts about a Rezulin safety study.


In 1999, FDA approved the GlaxoSmithKline drug Lotronex for the treatment of irritable bowel syndrome over FDA safety officers' objections. In November of 2000, Glaxo withdrew the drug from the market after reports of several deaths, the removal of a patient's colon, and bowel surgeries. Despite Lotronex's safety problems, FDA worked with GlaxoSmithKline to achieve a return of the drug to the market. It did so in the face of new studies showing that the drug increased patient risk of a life-threatening condition called ischemic colitis. Glaxo internal memos revealed that FDA's Center for Drug Evaluation and Research had been working with the manufacturer to assist it in managing media inquiries and in structuring the composition of a drug advisory committee panel to be favorable to the drug. The editor of The Lancet, Dr. Richard Horton, condemned FDA's actions saying, "this story reveals not only dangerous failings in a single drug's approval and review process but also the extent to which the FDA, its Center for Drug Evaluation and Research in particular, has become the servant of industry."


In 2001, Dr. Rudolph M. Widmark, who had been a drug safety officer at the FDA until 1997, told the Los Angeles Times, "[t]he basic message [in the new drug review process] is to approve. The people in charge don't say, 'Should we approve this drug?' They say, 'Hey, how can we get this drug approved?'"


Before 1995, FDA approved 60 percent of all new drug applications. By the end of that decade and to the present, the agency has approved over 80% of all new drug applications.


In December of 2003, the British Medicines and Healthcare Products Regulatory Agency (England's equivalent of our FDA) warned physicians in that country not to prescribe the anti-depressants Zoloft, Lexapro, Celexa, Luvox, Effexor, Serzone, Remeron, and Paxil to patients under 18 years of age. The British agency concluded that the anti-depressants were unsafe for juveniles and young adults because they increased the risk of suicidal behavior and hostility. FDA's lead expert on the safety of antidepressants, Dr. Andrew Mosholder, agreed with the British agency. He found a statistically significant increased risk of suicidal behavior among children taking those drugs. Children were 1.89 times more likely to become suicidal on those drugs than on placebo. When he voiced his views to his superiors at FDA, he was removed from the February 2004 advisory panel considering the safety of the drugs and was made the subject of a criminal investigation. Facing adverse publicity, FDA convened a second advisory panel seven months later in September of 2004 and recommended warning labels. FDA refused to take the drugs off the market for juveniles and young adults despite mounting evidence that the drugs were ineffective and dangerous.


In November of 2004, the Associate Director of FDA's Office of Drug Safety, Dr. David J. Graham, testified under the Whistleblower' Act before the Senate Finance Committee. He explained that the largest drug companies in the world exercised undue influence over FDA senior management. He said that repeatedly--over safety staff objections--FDA had approved unsafe drugs. In an interview he had in the September/October 2005 edition of Fraud magazine, Dr. Graham explained that he and other senior drug safety officers at FDA had urged the agency not to approve Vioxx, an arthritis drug manufactured by Merck, because it would substantially increase the risk of heart attack and stroke. FDA approved the drug over those objections. Some 20 million Americans took Vioxx. An estimated 140,000 suffered heart attacks, and, of those, 60,000 died.


Dr. Graham testified about FDA attempts to keep him from testifying before Congress concerning the FDA's decision to put Vioxx on the market despite its lethal effects. In an interview on my radio program Health Law and Politics on the Talk Star Radio Network, Dr. Graham explained that the then FDA Commissioner, Lester A. Crawford, on the eve of Graham's testimony before the Senate urged Graham not to testify but to take instead a position Crawford would create for him as an aide to the Commissioner. Crawford invited Graham to advise him on FDA's drug approval process at a higher pay grade. Graham declined. He said FDA management then orchestrated a media campaign, calls to his lawyer and to members of Congress, all designed to cause those contacted to distrust Graham and view him as inept.


In his Fraud magazine interview, Dr. Graham stated that "FDA is inherently biased in favor of the pharmaceutical industry. It views industry as its client, whose interests it must represent and advance." Graham also charged that "FDA has a well-established history of suppressing its scientists, of pressuring them to change their recommendations and conclusions if they are unfavorable about a drug and retaliates against those scientists who don't buckle under FDA pressure and threats."


Dr. Graham explained that the drug Serevent, for asthma, still on the market, was the subject of significant objection by FDA drug safety officers yet was approved nonetheless. The drug creates a four-fold increase in the risk of death from asthma. Dr. Graham speculates that this drug may be responsible for many asthma deaths around the world.


In the case of the drug Arava, for rheumatoid arthritis, also on the market, Dr. Graham and a colleague recommended against approval of the drug because it substantially increased the risk of acute liver failure. Dr. Graham reports that he and his colleague at FDA "were severely pressured to change our review, even to the point of being screamed at by a senior FDA manager while" Dr. Graham's supervisor (and that of his colleague) "looked on and did nothing to stop the abuse."


Although one would think the Vioxx debacle would have humbled FDA, please think again. On April 1, 2004, FDA approved the Sanofi-Aventis antibiotic Ketek despite warnings from four FDA drug safety officers (Dr. Charles Cooper, Dr. David Ross, Dr. Rosemary Johann-Liang, and Dr. David Graham) that the evidence supporting the drug was highly suspicious. FDA investigators found that Sanofi failed to disclose safety dangers that FDA drug safety officers later discovered. FDA's Dr. Cooper wrote, "I tried to argue that given Aventis's track record in which they have proven themselves to be untrustworthy that we have to consider the possibility that they are intentionally doing a poor job of collecting . . . data." FDA approved the drug despite those warnings and had the temerity to argue against the drug's withdrawal from the market based on the allegedly fraudulent data. Ketek has been implicated in fourteen incidents of liver failure, including four liver failure deaths. It remains on the market.


FDA frequently uses advisory committees comprised of scientists to evaluate drug safety and make recommendations on drug approvals. Members often have financial interests related to the products or topics under review. FDA routinely waives those conflicts of interest. This year the National Research Center for Women and Families published the results of a study conducted by the organization of FDA's Advisory Committee process. The National Research Center evaluated advisory committee meeting transcripts from January 1998 through December 2005. Among the findings:


Many advisory committees recommended approval for almost every product they review, usually unanimously.


Committee members describe pressure to conform and to recommend approval, and they candidly admit that their votes for approval may not be consistent with their concerns about safety and effectiveness.


The FDA almost always approves products recommended for approval but also often approves products that advisory committees reject.


Also this year the Union of Concerned Scientists revealed the results of a survey of senior scientists at FDA. 18.4% of 997 FDA scientists surveyed said that they had been asked for non-scientific reasons to inappropriately exclude or alter technical information or their conclusions in FDA scientific documents. 61% knew of cases where HHS or FDA political appointees have inappropriately injected themselves into FDA determinations or actions. 60% knew of cases where commercial interests have inappropriately induced or attempted to induce the reversal, withdrawal, or modification of FDA determinations or actions. Only half believe "FDA is acting effectively to protect the public health." 20% said they have been asked directly by FDA decision makers to provide incomplete, inaccurate, or misleading information to the public, regulated industry, media, or elected senior government officials.


To make matters worse, the FDA Center for Drug Evaluation and Research is now principally funded by the very drug companies it is supposed to regulate. Since 1992 over 50% of the funding for FDA's drug center has come from the drug companies themselves via fees paid under the Prescription Drug User Fees Act. Dr. Graham states, "[w]hen Congress passed this law I suppose it's possible that it didn't realize that PDUFA would lead to FDA becoming a captive of the industry it's supposed to regulate. However, that is what has happened, and to a disastrous end."


The pharmaceutical lobby not only affects FDA regulation of drugs but also FDA regulation of foods and dietary supplements. Truthful speech concerning the disease treatment effects of dietary ingredients is censored by the FDA. In 1990, Congress passed the Nutrition Labeling and Education Act. In that Act, Congress provided that foods and dietary supplements could make claims concerning the effects of dietary ingredients on disease without obtaining FDA drug approval. From 1990 until 1999, FDA refused to implement the NLEA health provision in case after case. Among the claims FDA censored from 1991 to 1993 was the claim that folic acid reduced the risk of neural tube defect births. An estimated 2,500 preventable neural tube defect births occurred each year FDA's censorship remained in place. Finally, on the eve of testifying before Congress and under intense public pressure and a law suit brought by my firm, Dr. David Kessler relented and allowed a claim for folic acid. FDA had refused to allow that claim despite the fact that the Centers for Disease Control and Prevention and the Public Health Service each recommended publicly that women of childbearing age consume 400 micrograms of folic acid daily before becoming pregnant to reduce their risk of having a neural tube defect birth.


In 1999, the United States Court of Appeals for the D.C. Circuit held FDA's censorship of four nutrient-disease relationship claims (including a folic acid claim/neural tube defect claim; an antioxidant vitamin/cancer risk reduction claim; a fiber/colorectal cancer risk reduction claim; and an omega-3 fatty acid/heart disease claim) unconstitutional under the First Amendment. The Court ordered FDA to favor disclosure of nutrient-disease information over its suppression and to allow the claims if they could be rendered nonmisleading with disclaimers. That landmark decision, Pearson v. Shalala, has opened the door to qualified health claims but FDA has been fast at work trying to close the door at every turn.


On remand, FDA refused to allow any of the claims the Pearson court held unconstitutionally suppressed. Four federal court decisions later, all against FDA, the claims have finally been allowed along with a half dozen others. Many well-backed claims, like the glucosamine and chondroitin sulfate/osteoarthritis claim, have been suppressed by FDA to protect the makers of non-steroidal anti-Inflammatory drugs from competition.


Moreover, in Whitaker v. Thompson II FDA succeeded in undermining the NLEA and the Pearson decision. It argued, contrary to the legislative history, that Congress intended health claims not to embrace every nutrient-disease relationship but only disease risk reduction claims. Every nutrient-disease treatment claim was, FDA argued, a drug claim that may not be communicated to the public even if true unless the dietary ingredient is approved as a drug (at $1.6 billion a pop, an economic impossibility). The Whitaker court upheld FDA's interpretation. Based on that win, the FDA now forbids reliance on almost all science concerning the treatment effects of nutrients and limits claims to nutrient disease risk reduction. The effect has been to foreclose all but a select few claims from being made. Thus, FDA has regained the censorship it was denied in Pearson. It once again favors censorship as the rule and disclosure as the rare exception--the very First Amendment violation the Pearson court condemned.


We learn from this history that if FDA fails to achieve an illegal and unconstitutional objective through one set of means, it will do so through another. It is relentless.


In 2004, FDA banned all ephedrine alkaloid containing dietary supplements. It did so despite an absence of any sound scientific evidence that ephedrine alkaloids at low dose levels presented a risk of illness or injury. It did so in flagrant violation of the plain and intended meaning of the dietary supplement adulteration provision. In that provision, Congress did not authorize FDA to compare risk of illness at any dose level against potential benefit to determine the existence of dietary supplement adulteration. It expected FDA to follow existing food adulteration precedent, making FDA bear the burden of proving a dietary ingredient (and not a hypothetical drug substitute) would present a risk of illness or injury at the dose levels recommended in labeling (and not at hypothetical dose levels). The FDA's ban was held a violation of the DSHEA's dietary supplement adulteration provision by the U.S. District Court for the District of Utah. Despite that decision, FDA enforced the illegal ban in contumacious disregard of the court's order all across the United States for an entire year. On appeal, the FDA just won a reversal of the district court's decision. That decision is itself on appeal. As with the health claims provision, so too with the adulteration provision, FDA has effectively rewritten the law in violation of the will of Congress to achieve its desired ends.


Although Congress plainly intended the DSHEA third party literature exemption to prohibit FDA from banning dietary supplement companies from distributing scientific articles containing nutrient-disease information, FDA has flouted the will of Congress and enforced the ban in derogation of the law. According to FDA, while a publication may be exempt from labeling under DSHEA, it may still prosecute the party that distributes the publication based on an intended use theory. The nutrient-disease content of the publication is said to be evidence that the nutrient is intended for use in the cure, treatment, mitigation, or prevention of disease, making the nutrient a drug. Thus, FDA has defeated the very purpose and meaning of the third party literature exemption as well.


The FDA has fulfilled the founding fathers' dire prediction of what would become of an agency of the government delegated by Congress legislative power. The FDA has become tyrannical. It is a law unto itself. It is unaccountable to the Congress. It is unaccountable to the courts. It is unaccountable to the American people. It is corrupt. It is the handmaiden of the pharmaceutical industry. Its decisions have sacrificed tens of thousands of Americans lives. It has gotten away with that history of homocide. What then do we need to do to end the law violations and to return this government to its constitutional moorings?


I recommend two interim and two long-term steps.


First, so long as FDA exercises control over drug approvals, its decision makers should be held personally liable for decisions that result in the infliction of disability and death.


(1) The Tort Claims Act should be amended to permit wrongful death and gross negligence actions to be filed against FDA management personally whenever someone suffers permanent disability or death as a result of a decision by FDA management to overrule recommendations against drug approval made by FDA scientific reviewers.


(2) Drug review panels should be chosen by a statutorily created, independent advisory body, not by FDA. Members should be screened to exclude those who have conflicts of interest, including ties to the pharmaceutical industry or to the FDA. The members should be paid for their services not by FDA but by the United States Treasury directly.


The FDA should have no authority to recommend panel members or to influence advisory panel meetings or modify advisory panel recommendations. All questions posed to the advisory panel should be submitted by FDA to the Department of Justice and modified by Justice as needed to ensure that none reveals a bias in favor of drug approval. FDA should be prohibited from acting contrary to a panel recommendation if that recommendation is against drug approval and if any FDA safety officers have also recommended against drug approval.


Long-term, Congress should end FDA censorship of nutrient-disease treatment claims by passing the Health Freedom Protection Act, H.R. 4282. In addition, Congress should amend the FDCA to remove from FDA the power to evaluate and approve new drugs. Instead, by statute, criteria should be established for drug evaluation to be conducted by government funded academic teams at universities qualified to do so who have no financial ties either to the pharmaceutical industry or to the FDA. Drug applications should be blinded so that reviewers are unaware of the company sponsor. The recommendations of these independent reviewers should be deemed final determinations, and the FDA should be required by law to follow those determinations.



[1] © 2006 Jonathan W. Emord. All rights reserved. Reproduction in whole or part without the express written consent of the author is strictly prohibited. Delivered September 23, 2006 at the Health Freedom Expo in Richmond, Virginia

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