ABLEnews Extra
          
          FDA Stalin Suppresses Free Speech

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Food and Drug Administration chief David Kessler magnanimously announced
early this month that his agency will loosen its restrictions on the use
of approved drugs for children's diseases and cancer. While the press
coverage of the announcement has been generally laudatory, the truth is,
rather than solving a deadly problem, the FDA could actually increase
its repression of American drug companies and the threat it poses to
American families. Rep. Newt Gingrich has made reform of the FDA a high
priority, and Dr. Kessler's latest action is further proof of the need
for radical changes.

The FDA imposes severe burdens on companies that want to offer better
drugs to the American people. According to a Tufts University study, it
takes a total of almost nine years for the FDA to grant approval to a
new drug. The FDA requires extensive tests and trials for new drugs,
running the average cost of drug approval to $230 million.

Dr. Kessler's announcement last week was the culmination of a policy
change he first announced in October 1992 before the American Academy of
Pediatrics. At the time, Dr. Kessler whined, "The FDA cannot require
firms to submit applications. We cannot require companies to conduct
trials on products they no longer want to pursue."

Dr. Kessler did note: "We do have powers of moral suasion [over drug
companies]. When it comes to drugs for severe and life- threatening
illnesses, I make no apologies about using those powers."

The FDA has far more than simply a power of "moral suasion"--the FDA can
bankrupt a company merely by slowing its application for a new drug
approval or by demanding ever more clinical tests on the drugs. FDA
employees have vast discretionary power, and drug companies are
notorious for kowtowing and groveling to the FDA's wishes. With the new
policy, the FDA will give drug companies two years to submit data
justifying the use of their drugs to treat pediatric illnesses. If the
FDA does not get as much information as it hopes, Dr. Kessler indicated
the agency could force companies to do clinical tests for their drugs on
children. As always, Dr. Kessler assumes the solution to every problem
is to give more power to government bureaucrats.

According to spokesman Steve Berchem, the Pharmaceutical Research and
Manufacturers of America views the new FDA policy change as "more stick
than carrot." Mr. Berchem notes, "Clinical trials can cost as much as
$30,000 per patients. Clinical studies literally have to involve
thousands of patients. If you throw in pediatric studies, that means
hundreds of thousands of children have to be involved." Mr. Berchem
concludes that Dr. Kessler's policy "seems to be more regulatory creep
than anything else."

The pediatric drug crisis stems in large part from the FDA's regulations
on drug labeling. Manufacturers must get formal FDA approval for each
specific use of their drug--or for using their drugs on different
populations, such as adults vs. children. A pharmaceutical company will
receive formal FDA approval for a drug to be used to treat a specific
type of cancer. Doctors, hospitals, and researchers often later discover
that the drug is also effective at treating other types of cancers and
report such uses in medical journals. Pharmaceutical companies routinely
publicize the results of further research on their drugs after the drugs
have been approved by the FDA. American Medical Association Vice
President Roy Schwarz estimates that off-label uses of drugs amount to
up to 60% of all drugs prescribed.

But in 1991, Dr. Kessler prohibited pharmaceutical companies from
informing doctors of new uses of approved drugs--banning them even from
distributing reprints of medical journal articles, for instance. Dr.
Kessler announced that the FDA would enforce the ban with seizures,
injunctions, and prosecutions.

The FDA issued proposed regulations and warned that, though the regs
were never finalized, companies would face wrath if they violated the
new rules. Dr. Kessler is effectively making death threats against
pharmaceutical companies if they commit the crime of distributing
certain information on life-saving uses of their drugs.

Among the dangerous contraband the FDA is suppressing to enforce its ban
are medical textbooks. Textbooks often discuss the latest developments
in pharmaceutical use, including uses not approved by the FDA.
Pharmaceutical companies often distribute free copies of textbooks to
physicians as a courtesy sales device. But last year, the FDA intervened
to prohibit a pharmaceutical company from distributing free copies of
The Chemotherapy Source Book-- even though the company had already
received FDA approval to purchase and give away thousands of copies.
(The Washington Legal Foundation is suing the FDA over this policy.)

The FDA's heavyhanded tactics are intimidating textbook publishers, who
fear that including the latest information on drug use may result in the
FDA restricting sales of their books. According to Kim Pearson,
publisher of Food and Drug Insider Report, "Several companies have
abandoned plans to include the most up-to-date drug use information
disclosed by medical journals for fear that the FDA will restrict
distribution of their texts in retaliation."

Even while Dr. Kessler is effectively compelling drug companies to
provide the FDA with information for its bureaucrats to sift on
pediatric effects of approved drugs, the FDA is continuing its threats
against drug companies that distribute medical journal articles or
textbooks mentioning potentially life-saving off- label usages of drugs
for children. The FDA acts as if it is better for children to die than
for drug companies to violate FDA's idiotic rules.

Dr. Kessler's passion for suppressing information about off-label uses
of drugs raises serious questions about his own work as a pediatrician.
Dr. Kessler himself observed that, as far as drug approval goes,
"pediatrics ends up being the real orphans because the trials and
studies are not done." This journalist has repeatedly faxed questions to
the Food and Drug Administration public information office demanding to
know the following: "Did Kessler ever use drugs for off-label uses when
he practiced as a pediatrician? If so, how often? Was he able to save
patients' lives by relying on off-label uses? Finally, how did he find
out about the off-label uses?" (The FDA has refused to answer any of
these questions.) It is possible that Dr. Kessler as FDA czar is
suppressing the same sources of information that he relied on when he
worked as a pediatrician.

Sam Kazman, an expert on the FDA and a lawyer with the Competitive
Enterprise Institute, observed, "Kessler has refused to acknowledge that
maybe they should not have had those rules in the first place. He is in
effect announcing a loosening of certain FDA regulations, but there is
no admission whatsoever that all he is doing is correcting an FDA
blunder. How many children might have died thanks to the FDA policies?"

Dr. Kessler's latest power-grab is part of a long pattern.
 
Mr. Gingrich recently denounced the FDA as a "Stalinistic" agency. While
Mr. Gingrich's comment may be hyperbolic, there are some interesting
parallels between Dr. Kessler's responses to the FDA's problems and
Josef Stalin's response to the problems of the Soviet planned economy in
the late 1920s and early 1930s.

Dr. Kessler, like Stalin, faced a system mired in wrong incentives and
permeated by government roadblocks to progress. Dr. Kessler, like
Stalin, instead of fixing the obvious problems, has issued one
denunciation after another of those who opposed or disagreed with him.
Dr. Kessler, like Stalin, has sought to maximize fear in the
regulated/controlled industries by maximizing the uncertainty of
government policy. Dr. Kessler, like Stalin, has seized on every
disruption caused by government intervention (such as the crackdown on
off-label advertisements caused in large part by the FDA's inexcusable
delays on the approvals of drug use) to further increase government
power. Stalin sought to solve the problems of defects and crashes among
advanced Soviet Air Force fighter planes by executing some of the
aircraft engineers; Dr. Kessler has responded to the occasional problems
of new medical devices with a de facto regulatory pogrom that is exiling
the industry.

Instead of giving the FDA more power over drug companies, we should give
Americans more freedom to use the best medicine they can find. The FDA
must stop this Sovietization of knowledge of drug uses and learn to
respect the First Amendment.

[Medical Follies at the FDA, James Brovard, Washington Times, 12/20/94]

ABLEnews Editor's Note: Mr. Brovard is the author of Last Rights: The
                        Destruction of American Liberty (St. Martin's
                        Press, 1994). Portions of the above article will
                        appear in the January American Spectator.

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