Read "fda violation of the rule of law"

Read "FDA Violation of the Rule of Law" 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 TalkStar 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 toit by C ongress. It is also the repository of powers not delegated by Congress that FDA hasusurped beyond the limits of its enabling statute throughout its 68 year history. TheCommissioner of FDA sits at the pleasure of the President. The FDA is one of the largest andmost powerful federal bureaucracies. It regulates over $1 trillion dollars of goods. Theproducts under its jurisdiction account for 25 cents of every dollar spent by Americanconsumers. FDA has approximately ten thousand employees and 26 district offices across theUnited States. The United States Attorneys and federal marshals are at its disposal and canobtain search and seizure warrants to be exercised without any advance notice against anycompany that sells a food, dietary supplement, drug, or medical device in the United States.
Emord & Associates
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 Telephone: (202) 466-6937Telecopier: (202) 466-6938 power from the duly elected representatives of Congress to any other entity. They warnedthat if legislative power were combined with executive power, or if legislative power werecombined with judicial power, our republic would become an oligarchy and the rights of thepeople 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 everyother up to that time in the American colonies and would achieve resounding popularitythroughout Europe. It was Common Sense. Written anonymously by Thomas Paine, thatpamphlet became the most influential tract in revolutionary America. In it Paine explained thequintessential defining principle of our polity, the very reason why we could not endure thearbitrary will of King George III and would rebel to form a new nation. He begged forrevolution against Great Britain because the King had usurped rights and powers of the peopleand 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, anddoth not make havoc of mankind like the Royal Brute of Britain. Yet that wemay not appear to be defective in earthly honors, let a day be solemnly setapart for proclaiming the charter . . . . that in America the law is King. For as inabsolute governments the King is law, so in free countries the law ought to beKing; and there ought to be no other.
Read "FDA Violation of the Rule of Law" The defining principle of the American republic was that governments are instituted amongmen to protect the rights of the governed, that to accomplish that task governmental powersmust be limited and defined in written law and separated in the hands of independentlegislative, executive, and judicial departments with a system of checks and balances toprevent the accumulation of the separate powers into any single department. The Frenchphilosopher Montesquieu argued for the separation of powers in his 1748 treatise The Spirit ofthe Laws. That book greatly influenced the founding fathers, as did endorsements of thedoctrine by John Locke and other British Whig writers of the 18th Century. Historian ForrestMcDonald explains that all leading politicos of the Founding Era "could recite central points ofMontesquieu's doctrine of separation of powers as if it had been a catechism." In The Spirit ofthe Laws Montesquieu wrote: [T]here is no liberty if the power of judging be not separated from thelegislative and executive powers. Were it joined with the legislative, the life andliberty of the subject would be exposed to arbitrary control, for the judge wouldthen be the legislator. Were it joined to the executive power, the judge mightbehave with all the violence of an oppressor . . . . There would be an end ofeverything were the same man, or the same body . . . to exercise those threepowers . . . of enacting laws . . . of executing [laws]. . . and . . . of judging thecrimes or differences of individuals . . . .
In Federalist No. 47, James Madison argued for the rule of law over the arbitrary will of thosein power, explaining that our Constitution would define "a government of laws and not ofmen." The phrase, common among the founding generation, meant that there was to be noplace in government for the exercise of arbitrary will over the lives, liberties, or properties ofthe American people. Just as we were to be ruled by laws, our law itself was to be the productof separate, competing legislative, executive, and judicial power centers; never were any twoof those powers to be combined in a single center. Madison wrote, "[t]he accumulation of allpowers, 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 verydefinition of tyranny." Typical of the Federalists who advocated ratification of the Constitution,Alexander Hamilton explained that the separation of powers was "itself, in every rationalsense, and to every useful purpose, A BILL OF RIGHTS." It would deny a single departmentautonomous governance. It would keep abuse of power in check by humbling those ingovernment with the need to satisfy the dictates of competing power centers.
Like Montesquieu, the Framers viewed political liberty as a condition in whichcitizens are free from arbitrary power and can expect to be secure in theirpersons and property. As Montesquieu put it in The Spirit of the Laws, "[t]hepolitical liberty of the subject is a tranquility of mind, arising from the opinioneach person has of his safety." C oncentration of two or more of the threeclasses of power--legislative, executive, judicial--in a single organ ofgovernment would destroy that tranquility for reasons that John Adamsexpressed succinctly in a pamphlet published in 1776: "Because a singleassembly, possessed of all the powers of government, would make arbitrarylaws 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 thearbitrary will of those in power. The separation of powers assures that no single power centermay create, execute, and judge the law but must obtain the consent of the other, independentpower centers to achieve those ends. When the separation of powers and the system ofchecks and balances is gone, so is the security needed for the preservation of liberty from thearbitrary will of those in government.
From 1787 until 1937, the constitutional law of this country prohibited administrators frompossessing combined legislative, executive, and judicial powers, but for the last 69 years, theSeparation of Powers doctrine has been largely abandoned in favor of oligarchic rule by theindependent regulatory commissions. That rule has produced rights violations, massivetransfers of wealth from private to public hands, government protectionism for industry Read "FDA Violation of the Rule of Law" leaders over new market entrants, vast corruption, and explosive growth in the size and scopeof the federal government. The independent regulatory commissions, and the FDA inparticular, are destroying free enterprise and individual liberty in America.
So what happened in 1937 to undue the Framers' constitutional design, the separation ofpowers doctrine?Accepting the Republican nomination for President in 1928, Herbert Hoover with greatexuberance and confidence predicted, "We in America today are nearer to the final triumphover 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 theGreat Depression, an economic collapse that reverberated worldwide. From 1929 to 1933, theUnited 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 losthis re-election bid to Franklin Delano Roosevelt on Roosevelt's promise of a New Deal to endwidespread poverty through government largesse.
Shortly after his inauguration in March of 1933, President Roosevelt proposed laws thatgranted sweeping legislative, executive, and judicial powers to new executive branchagencies. Although the Supreme Court upheld many of these laws, it refused to do so in the1935 A.L.A. Schechter Poultry Corp. v. U.S. decision. Schechter Poultry struck downRoosevelt's National Industrial Recovery Act of 1933. A unanimous Court held that Title I ofthe NIRA constituted an "unconstitutional delegation of legislative power to the executive."Chief Justice Charles Evans Hughes wrote for the Court: "Congress is not permitted toabdicate or to transfer to others the essential legislative function with which it is thus vested."In a concurrence, Justice Benjamin C ardozo referred to the industrial code provisions of theNIRA as "delegation [of power] running riot." The Court thus demanded adherence to theseparation of powers doctrine embodied in the Constitution.
The Court's actions did not sit well with President Roosevelt. Following his re-election to officeand preceding his plans for the enactment of additional executive branch agencies investedwith legislative, executive, and judicial powers, President Roosevelt proposed the JudiciaryReorganization Act of 1937. The Act would give President Roosevelt the power to appoint anextra Supreme Court Justice for every sitting Justice over the age of 70 and six months. Six ofthe Justices on the High Court were over 70 and six months. The Justices predisposed againstdelegation had held a slim one vote majority (5 to 4). Roosevelt's threatened court packingplan never was enacted but the threat alone provoked the desired response. It produced whatthe 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 LouisBrandeis; Benjamin Cardozo; and Harlan Stone). Within a year, conservative Justices VanDeVanter and Sutherland retired, replaced by the pro-New Deal Justices Hugo Black andStanley Reed.
That shift in the C ourt's alignment led to the near total erosion of the separation of powersdoctrine, resulting in massive legislative delegations of power to independent regulatorycommissions, among them the U.S. Food and Drug Administration.
Over the years independent regulatory commissions have not only come to exercise powersintended to be vested in Congress but they have also become legislatures themselves--promulgating regulations that exceed statutory limits and running roughshod over individualliberties designedly protected by the Bill of Rights. The rule of law has been replaced by thearbitrary will of unelected and unaccountable federal bureaucrats. The FDA is an excellentcase in point.
Congressional delegations of legislative power to FDA, and FDA usurpations of power, oftenoccur 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 Read "FDA Violation of the Rule of Law" Massengill Company to reformulate a sulfa drug into a liquid form resulted in the deaths of 107children. The company sold the liquid drug in a syrup that included diethylene glycol as asolvent. That is anti-freeze. Although Massengill was convicted of gross negligence, theRoosevelt administration, feeling its oats after the "switch in time that saved nine," called foradoption of the Food, Drug and Cosmetic Act of 1938. That law required companies to submitNew Drug Applications (NDA's) before introducing new pharmaceuticals into interstatecommerce. In concessions to the leading drug makers, the law grandfathered as lawful alldrugs then on the market and created costly safety testing barriers to entry. Each NDA had todocument tests that proved a drug safe at recommended dosages. NDAs were automaticallyapproved 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 ofdeformed newborns began appearing across Europe--victims of the sedative thalidomide.
Although existing law included safety reviews that would presumably prevent the sale ofthalidomide in the United States, FDA, the pharmaceutical industry, and sympathetic membersof Congress argued for expanded FDA powers based on the thalidomide catastrophe. TheKefauver-Harris Drug Amendments became law in 1962. Under the 1938 Act, NDAs wereapproved unless FDA acted to deny them. Under the 1962 Act, NDAs were denied unless FDAacted to approve them. For an NDA to be granted, FDA had to conclude that the new drug wassafe and effective. With the support of the pharmaceutical industry, FDA translated the law intoa Byzantine system of clinical trial proofs, not involving product testing by the FDA butinvolving 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 millionper drug (that cost has now risen to $1.6 billion per drug). The day of the governmentprotected monopolist had arrived for the drug industry.
The 1962 Act also transferred to FDA from FTC jurisdiction over drug advertising--a moveurged by the pharmaceutical industry because it lacked the kind of influence over FTC that ithad long enjoyed over FDA. The bill codified cGMPs, another barrier to entry into the drugmarket, and gave FDA expanded inspection powers, yet another barrier. The drug industrylobbied for the bill.
The same year FDA acquired vast new powers to regulate drugs, it tried to expand its drugregulation to eliminate a burgeoning new source of competition for drugs, dietarysupplements. Evidence began to reveal that dietary ingredients had therapeutic effects. Thefar sighted in the pharmaceutical industry and at the FDA perceived a competitive threatemerging to drug regulation from the sale of dietary ingredients at above RDA doses. Tocounter that threat, and without the slightest grant of legislative authority from Congress, FDApublished 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 ormineral would automatically be regulated as a drug. Once declared a drug, the supplementcould not be lawfully marketed in the United States without FDA drug approval. The dietarysupplement industry challenged the rule in federal court with mixed results. Public outcryagainst the rule reached a fever pitch. On April 22, 1976, after intense public lobbying againstthe rule, Senator William Proxmire introduced an amendment to the Heart and Lung Act andthe amended Act became law. It prohibited FDA from classifying a vitamin or a mineral as adrug based on its potency.
Undaunted, FDA tried yet again to rid the market of vitamins in the 1970s by claiming on acase by case basis that they were adulterated based on their potency. The federal courtsrefused to cooperate with this attempt at an end-run around the Proxmire Amendment. FDAtried another approach in the 1970s. It declared supplements to be unapproved FoodAdditives. Under the Food Additives provision of the FDCA, no food additive may be soldunless the manufacturer proves it safe to FDA's satisfaction. In this way, FDA planned to makeproving the safety of supplements so difficult that it would drive them out of the market. FDA'sposition was a logical absurdity: Single ingredient dietary supplements were food additivesbecause the ingredients were added to a gelatin capsule which was, FDA said with a wink and Read "FDA Violation of the Rule of Law" a smirk, a food. The federal courts rejected this effort. The United States Court of Appeals forthe First Circuit described FDA's approach as "nonsensical." The United States Court ofAppeals 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 drugmonograph for vitamins and minerals, declaring potencies above the RDA to fall within thescope 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 changesdesigned to protect drug companies from competition. Many times those changes have comeat the cost of human life. Courts have occasionally held FDA's actions unlawful. Rarely hasFDA respected court decisions against its exercise of authority. The agency's usual course iseither 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'slack of respect for the rule of law, its destruction of the rule of law itself, was a consequencepredicted by the Framers of the Constitution who warned against delegation of legislativepowers.
Since 1962, people within the FDA itself and outside the agency have complained bitterly thatFDA is unduly influenced by drug companies. The complaining parties are many, haveexcellent reputations for honesty, and have spoken against their own economic interests andat considerable personal risk of FDA retaliation. FDA has approved numerous drugs over theobjections of its drug safety officers. A significant number of those drugs have been withdrawnfrom the market following occurrence of the very harms predicted by FDA's drug safetyofficers. The following drugs are among those FDA allowed Into the market over the objectionsof its drug safety officers. Each of the drugs was subsequently withdrawn from the marketwhen the predicted harms actually occurred: GlaxoSmithKline's Lotronex for irritable bowelsyndrome; American Home Products' Redux, a diet aid; Bayer Corporation's Raxav, anantibiotic; 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 furcoat and a videocassette recorder) from drug company lobbyists in exchange for making surethat their drugs were assigned to subordinates Chang knew to be quick reviewers. Through hisassignment of work, Chang manipulated the approval schedule to the advantage of those whogave him bribes. Given a tip to investigate the corruption by Barr Laboratories, theDepartment of Justice and the FBI uncovered corrupt practices within the agency's genericdrug division. The sting landed Chang in federal prison and caused 42 others and 10companies to be convicted on charges of fraud and corruption. The scandal shookcongressional confidence in FDA. It brought down the FDA Commissioner Frank Young whoresigned in November 1989. Although FDA was clearly in the wrong, senior management atthe agency resented Barr Laboratories disclosures to the Justice Department, FBI, andCongress. 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 overobjections from several FDA drug safety officers that Rezulin significantly increased liverenzyme levels and would cause liver failure and death. Complaining that politics ruled overscience at the agency, the FDA's drug safety officer Robert Misbin resigned. Frustrated withFDA management for approving Rezulin despite its lethal dangers, Misbin said he knew peoplewould die and did "not want to stay around for what's going to happen." Not willing to sit idlyby while the bodies piled up, Misbin complained to Congress. The FDA retaliated by givingMisbin his first negative job performance review and commenced an internal investigationagainst him. Members of Congress condemned FDA's actions. Misbin was not the first FDAscientist to be persecuted for complaining about Rezulin safety problems. FDA Internal Affairsinterrogated Dr. Leo Lutwak, whom they also accused of leaking data on Rezulin. FDA InternalAffairs investigated Dr. John Gueriguian, the original scientist in charge of FDA's review of theRezulin trials, after he also insisted that Rezulin was too dangerous to be sold. DoctorsGueriguian and Lutwak retired from FDA rather than face the costly investigations. Lutwak told Read "FDA Violation of the Rule of Law" CBS News, "In my own agency I'm treated like.I'm treated worse than a criminal! I'maccused, I'm threatened, I'm taken away from my work." CBS News also reported that tworesearchers at Warner-Lambert who conducted clinical trials on Rezulin claimed the companytold them to downplay problems with the drug. FDA documents showed tests of the drug foundliver enzyme levels six times normal, but Warner-Lambert reported levels of "2 to 3times.normal," a figure the company later acknowledged to be incorrect.
Rezulin was withdrawn from the market after it was associated with 391 deaths, including 63from 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 aRezulin safety study.
In 1999, FDA approved the GlaxoSmithKline drug Lotronex for the treatment of irritable bowelsyndrome over FDA safety officers' objections. In November of 2000, Glaxo withdrew the drugfrom the market after reports of several deaths, the removal of a patient's colon, and bowelsurgeries. Despite Lotronex's safety problems, FDA worked with GlaxoSmithKline to achieve areturn of the drug to the market. It did so in the face of new studies showing that the drugincreased patient risk of a life-threatening condition called ischemic colitis. Glaxo internalmemos revealed that FDA's Center for Drug Evaluation and Research had been working withthe manufacturer to assist it in managing media inquiries and in structuring the composition ofa 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 dangerousfailings in a single drug's approval and review process but also the extent to which the FDA, itsCenter 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 toapprove. The people in charge don't say, 'Should we approve this drug?' They say, 'Hey, howcan we get this drug approved?'"Before 1995, FDA approved 60 percent of all new drug applications. By the end of that decadeand 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 patientsunder 18 years of age. The British agency concluded that the anti-depressants were unsafe forjuveniles 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 theBritish agency. He found a statistically significant increased risk of suicidal behavior amongchildren taking those drugs. Children were 1.89 times more likely to become suicidal on thosedrugs than on placebo. When he voiced his views to his superiors at FDA, he was removedfrom the February 2004 advisory panel considering the safety of the drugs and was made thesubject of a criminal investigation. Facing adverse publicity, FDA convened a second advisorypanel seven months later in September of 2004 and recommended warning labels. FDArefused to take the drugs off the market for juveniles and young adults despite mountingevidence 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. Heexplained that the largest drug companies in the world exercised undue influence over FDAsenior management. He said that repeatedly--over safety staff objections--FDA had approvedunsafe drugs. In an interview he had in the September/October 2005 edition of Fraudmagazine, Dr. Graham explained that he and other senior drug safety officers at FDA hadurged the agency not to approve Vioxx, an arthritis drug manufactured by Merck, because itwould substantially increase the risk of heart attack and stroke. FDA approved the drug overthose objections. Some 20 million Americans took Vioxx. An estimated 140,000 suffered heartattacks, and, of those, 60,000 died.
Dr. Graham testified about FDA attempts to keep him from testifying before Congress Read "FDA Violation of the Rule of Law" concerning the FDA's decision to put Vioxx on the market despite its lethal effects. In aninterview 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 ofGraham's testimony before the Senate urged Graham not to testify but to take instead aposition Crawford would create for him as an aide to the Commissioner. Crawford invitedGraham to advise him on FDA's drug approval process at a higher pay grade. Grahamdeclined. He said FDA management then orchestrated a media campaign, calls to his lawyerand to members of Congress, all designed to cause those contacted to distrust Graham andview him as inept.
In his Fraud magazine interview, Dr. Graham stated that "FDA is inherently biased in favor ofthe pharmaceutical industry. It views industry as its client, whose interests it must representand advance." Graham also charged that "FDA has a well-established history of suppressing itsscientists, of pressuring them to change their recommendations and conclusions if they areunfavorable about a drug and retaliates against those scientists who don't buckle under FDApressure and threats."Dr. Graham explained that the drug Serevent, for asthma, still on the market, was the subjectof significant objection by FDA drug safety officers yet was approved nonetheless. The drugcreates a four-fold increase in the risk of death from asthma. Dr. Graham speculates that thisdrug 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 acolleague recommended against approval of the drug because it substantially increased therisk of acute liver failure. Dr. Graham reports that he and his colleague at FDA "were severelypressured to change our review, even to the point of being screamed at by a senior FDAmanager while" Dr. Graham's supervisor (and that of his colleague) "looked on and didnothing to stop the abuse."Although one would think the Vioxx debacle would have humbled FDA, please think again. OnApril 1, 2004, FDA approved the Sanofi-Aventis antibiotic Ketek despite warnings from fourFDA 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. FDAinvestigators found that Sanofi failed to disclose safety dangers that FDA drug safety officerslater discovered. FDA's Dr. Cooper wrote, "I tried to argue that given Aventis's track record inwhich they have proven themselves to be untrustworthy that we have to consider thepossibility that they are intentionally doing a poor job of collecting . . . data." FDA approvedthe drug despite those warnings and had the temerity to argue against the drug's withdrawalfrom the market based on the allegedly fraudulent data. Ketek has been implicated in fourteenincidents 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 andmake recommendations on drug approvals. Members often have financial interests related tothe products or topics under review. FDA routinely waives those conflicts of interest. This yearthe National Research Center for Women and Families published the results of a studyconducted by the organization of FDA's Advisory Committee process. The National ResearchCenter evaluated advisory committee meeting transcripts from January 1998 throughDecember 2005. Among the findings: Many advisory committees recommended approval for almost every productthey review, usually unanimously.
Committee members describe pressure to conform and to recommendapproval, and they candidly admit that their votes for approval may not beconsistent with their concerns about safety and effectiveness.
The FDA almost always approves products recommended for approval but alsooften approves products that advisory committees reject.
Also this year the Union of Concerned Scientists revealed the results of a survey of senior Read "FDA Violation of the Rule of Law" scientists at FDA. 18.4% of 997 FDA scientists surveyed said that they had been asked fornon-scientific reasons to inappropriately exclude or alter technical information or theirconclusions in FDA scientific documents. 61% knew of cases where HHS or FDA politicalappointees have inappropriately injected themselves into FDA determinations or actions. 60%knew of cases where commercial interests have inappropriately induced or attempted toinduce the reversal, withdrawal, or modification of FDA determinations or actions. Only halfbelieve "FDA is acting effectively to protect the public health." 20% said they have been askeddirectly by FDA decision makers to provide incomplete, inaccurate, or misleading informationto the public, regulated industry, media, or elected senior government officials.
To make matters worse, the FDA Center for Drug Evaluation and Research is now principallyfunded by the very drug companies it is supposed to regulate. Since 1992 over 50% of thefunding for FDA's drug center has come from the drug companies themselves via fees paidunder the Prescription Drug User Fees Act. Dr. Graham states, "[w]hen Congress passed thislaw I suppose it's possible that it didn't realize that PDUFA would lead to FDA becoming acaptive of the industry it's supposed to regulate. However, that is what has happened, and to adisastrous end."The pharmaceutical lobby not only affects FDA regulation of drugs but also FDA regulation offoods and dietary supplements. Truthful speech concerning the disease treatment effects ofdietary ingredients is censored by the FDA. In 1990, Congress passed the Nutrition Labelingand Education Act. In that Act, Congress provided that foods and dietary supplements couldmake claims concerning the effects of dietary ingredients on disease without obtaining FDAdrug approval. From 1990 until 1999, FDA refused to implement the NLEA health provision incase after case. Among the claims FDA censored from 1991 to 1993 was the claim that folicacid reduced the risk of neural tube defect births. An estimated 2,500 preventable neural tubedefect births occurred each year FDA's censorship remained in place. Finally, on the eve oftestifying before Congress and under intense public pressure and a law suit brought by myfirm, Dr. David Kessler relented and allowed a claim for folic acid. FDA had refused to allowthat claim despite the fact that the Centers for Disease Control and Prevention and the PublicHealth Service each recommended publicly that women of childbearing age consume 400micrograms of folic acid daily before becoming pregnant to reduce their risk of having a neuraltube defect birth.
In 1999, the United States Court of Appeals for the D.C. Circuit held FDA's censorship of fournutrient-disease relationship claims (including a folic acid claim/neural tube defect claim; anantioxidant 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 suppressionand to allow the claims if they could be rendered nonmisleading with disclaimers. Thatlandmark decision, Pearson v. Shalala, has opened the door to qualified health claims but FDAhas 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 unconstitutionallysuppressed. Four federal court decisions later, all against FDA, the claims have finally beenallowed along with a half dozen others. Many well-backed claims, like the glucosamine andchondroitin sulfate/osteoarthritis claim, have been suppressed by FDA to protect the makers ofnon-steroidal anti-Inflammatory drugs from competition.
Moreover, in Whitaker v. Thompson II FDA succeeded in undermining the NLEA and thePearson decision. It argued, contrary to the legislative history, that Congress intended healthclaims not to embrace every nutrient-disease relationship but only disease risk reductionclaims. Every nutrient-disease treatment claim was, FDA argued, a drug claim that may not becommunicated 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 thetreatment effects of nutrients and limits claims to nutrient disease risk reduction. The effecthas been to foreclose all but a select few claims from being made. Thus, FDA has regained thecensorship it was denied in Pearson. It once again favors censorship as the rule and disclosureas the rare exception--the very First Amendment violation the Pearson court condemned.
Read "FDA Violation of the Rule of Law" We learn from this history that if FDA fails to achieve an illegal and unconstitutional objectivethrough 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 despitean absence of any sound scientific evidence that ephedrine alkaloids at low dose levelspresented a risk of illness or injury. It did so in flagrant violation of the plain and intendedmeaning of the dietary supplement adulteration provision. In that provision, Congress did notauthorize FDA to compare risk of illness at any dose level against potential benefit todetermine the existence of dietary supplement adulteration. It expected FDA to follow existingfood adulteration precedent, making FDA bear the burden of proving a dietary ingredient (andnot a hypothetical drug substitute) would present a risk of illness or injury at the dose levelsrecommended in labeling (and not at hypothetical dose levels). The FDA's ban was held aviolation of the DSHEA's dietary supplement adulteration provision by the U.S. District Courtfor the District of Utah. Despite that decision, FDA enforced the illegal ban in contumaciousdisregard of the court's order all across the United States for an entire year. On appeal, theFDA just won a reversal of the district court's decision. That decision is itself on appeal. As withthe health claims provision, so too with the adulteration provision, FDA has effectivelyrewritten 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 FDAfrom banning dietary supplement companies from distributing scientific articles containingnutrient-disease information, FDA has flouted the will of Congress and enforced the ban inderogation of the law. According to FDA, while a publication may be exempt from labelingunder DSHEA, it may still prosecute the party that distributes the publication based on anintended use theory. The nutrient-disease content of the publication is said to be evidence thatthe 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 thirdparty literature exemption as well.
The FDA has fulfilled the founding fathers' dire prediction of what would become of an agencyof 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. Itis unaccountable to the American people. It is corrupt. It is the handmaiden of thepharmaceutical industry. Its decisions have sacrificed tens of thousands of Americans lives. Ithas gotten away with that history of homocide. What then do we need to do to end the lawviolations 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 heldpersonally 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 grossnegligence actions to be filed against FDA management personally wheneversomeone suffers permanent disability or death as a result of a decision by FDAmanagement to overrule recommendations against drug approval made by FDAscientific reviewers.
(2) Drug review panels should be chosen by a statutorily created, independentadvisory body, not by FDA. Members should be screened to exclude those whohave conflicts of interest, including ties to the pharmaceutical industry or to theFDA. The members should be paid for their services not by FDA but by theUnited States Treasury directly.
The FDA should have no authority to recommend panel members or to influence advisorypanel meetings or modify advisory panel recommendations. All questions posed to theadvisory panel should be submitted by FDA to the Department of Justice and modified byJustice as needed to ensure that none reveals a bias in favor of drug approval. FDA should beprohibited from acting contrary to a panel recommendation if that recommendation is againstdrug approval and if any FDA safety officers have also recommended against drug approval.
Read "FDA Violation of the Rule of Law" Long-term, Congress should end FDA censorship of nutrient-disease treatment claims bypassing the Health Freedom Protection Act, H.R. 4282. In addition, Congress should amend theFDCA 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 fundedacademic teams at universities qualified to do so who have no financial ties either to thepharmaceutical industry or to the FDA. Drug applications should be blinded so that reviewersare unaware of the company sponsor. The recommendations of these independent reviewersshould be deemed final determinations, and the FDA should be required by law to follow thosedeterminations.
[1] 2006 Jonathan W. Emord. All rights reserved. Reproduction in whole or part without theexpress written consent of the author is strictly prohibited Delivered September 23 2006 at E mord & A s s oc iates is dedic ated to s erving the needs of its national c lient bas e. T he firm’s attorneys repres ent c lients in c ons titutional and adminis trative lawc as es before the Food and D rug A dminis tration (FDA ), the Federal T rade C ommis s ion (FT C ), the D rug E nforc ement A dminis tration (DE A ), the D epartment ofJus tic e (D O J), the Department of the I nterior, the Bureau of Land M anagement (BLM ), the N ational P ark Servic e (N P S), the E qual E mployment O pportunityC ommis s ion, the E nvironmental P rotec tion A genc y (E P A ), and the Federal C ommunic ations C ommis s ion (FC C ).
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