ABLEnews Extra FDA Stalin Suppresses Free Speech [The following file may be freq'd as FDA41220.* from 1:109/909 and other BBS's that carry the ABLEFiles Distribution Network (AFDN) and--for about one week-- ftp'd from FTP.FIDONET.ORG on the Internet. Please allow a few days for processing.] 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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