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12/16/2010
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FDA VIOLATION OF THE RULE OF LAW [1]
By Jonathan W. Emord
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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 C ongress. It is also the repository of powers not delegated by C ongress that FDA has
usurped beyond the limits of its enabling statute throughout its 68 year history. The
C ommissioner 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.
Emord & Associates
To understand how FDA has acquired so much power in a government designedly of limited
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powers, we have to appreciate the agency's place in history. Indeed, we have to start with the
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written C onstitution where the law and a system of separation of powers and checks and
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single hands in violation of our founding principles. We must then come to see how FDA in
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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 C entury rejection of the arbitrary will of King George III, its embrace of a
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
C entury and how those commissions united legislative, executive, and judicial powers into
particular exemplifies the arbitrary rule of people in power over the rule of law.
The Framers of our C onstitution prohibited the federal government from delegating legislative
power from the duly elected representatives of C ongress 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.
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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 C ommon 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.
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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 C entury. 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 C onstitution 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 C onstitution,
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." C oncentration 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
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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 C ourt upheld many of these laws, it refused to do so in the
1935 A.L.A. Schechter Poultry C orp. v. U.S. decision. Schechter Poultry struck down
Roosevelt's National Industrial Recovery Act of 1933. A unanimous C ourt held that Title I of
the NIRA constituted an "unconstitutional delegation of legislative power to the executive."
C hief Justice C harles Evans Hughes wrote for the C ourt: "C ongress 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 C ardozo referred to the industrial code provisions of the
NIRA as "delegation [of power] running riot." The C ourt thus demanded adherence to the
separation of powers doctrine embodied in the C onstitution.
The C ourt'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 C ourt Justice for every sitting Justice over the age of 70 and six months. Six of
the Justices on the High C ourt 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 C ourt (the so-called Four Horsemen,
Justices James C lark McReynolds; George Sutherland; Willis Van DeVanter; and Pierce Butler)
voted with the liberal wing of the C ourt (the so-called Three Musketeers, Justices Louis
Brandeis; Benjamin C ardozo; 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 C ourt'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 C ongress 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.
C ongressional 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
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Massengill C ompany 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 C osmetic 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 C ongress 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 C ongress, 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 FDC A, 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
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a smirk, a food. The federal courts rejected this effort. The United States C ourt of Appeals for
the First C ircuit described FDA's approach as "nonsensical." The United States C ourt of
Appeals for the Seventh C ircuit 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. C ourts 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 C onstitution 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 C orporation'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 C harles C hang 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 C hang knew to be quick reviewers. Through his
assignment of work, C hang 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 C hang 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 C ommissioner 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
C ongress. C ommissioner 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. C omplaining 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 C ongress. The FDA retaliated by giving
Misbin his first negative job performance review and commenced an internal investigation
against him. Members of C ongress 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
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C BS 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." C BS 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 C enter 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
C enter 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 antidepressants Zoloft, Lexapro, C elexa, 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. C hildren 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 C ommittee. 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 C ongress
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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 C ommissioner, Lester A. C rawford, on the eve of
Graham's testimony before the Senate urged Graham not to testify but to take instead a
position C rawford would create for him as an aide to the C ommissioner. C rawford 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 C ongress, 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. C harles C ooper, 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. C ooper 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 C enter for Women and Families published the results of a study
conducted by the organization of FDA's Advisory C ommittee process. The National Research
C enter 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.
C ommittee 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 C oncerned Scientists revealed the results of a survey of senior
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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 C enter 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 C ongress 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, C ongress passed the Nutrition Labeling
and Education Act. In that Act, C ongress 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 C ongress 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 C enters for Disease C ontrol 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 C ourt of Appeals for the D.C . C ircuit 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 C ourt 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 C ongress 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.
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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, C ongress 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 C ourt
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 C ongress to achieve its desired ends.
Although C ongress 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 C ongress 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 C ongress legislative power. The FDA has become tyrannical.
It is a law unto itself. It is unaccountable to the C ongress. 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 C laims 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.
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Long-term, C ongress should end FDA censorship of nutrient-disease treatment claims by
passing the Health Freedom Protection Act, H.R. 4282. In addition, C ongress should amend the
FDC A 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
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