FDA's New Year Gift to Big Pharma

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FDA's New Year Gift to Big Pharma
	2006-01-20 03:19:49
From: SSRI-Research  Date: Thu, 19 Jan 2006 20:49:52 -0500 Subject: [SSRI-Research] FDA's New Year Gift to Big Pharma FDA's New Year Gift to Big Pharma ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting Openness, Full Disclosure, and Accountability www.ahrp.org FYI The FDA has issued new rules to shield the drug manufacturers from liability from harm encouraging the marketing of defective drugs that have induced debilitating life-threatening chronic diseases such as diabetes (Zyprexa, Risperdal). And immunity from marketing outright lethal drugs (such as Vioxx, FenPhen--which the FDA had approved and whose labels when they were marketed did not warn consumers about the risks. FDA's new rule provides the avenue for shutting the  door of justice in consumers' faces. "not only an end-run around current law but also a broad extension of the Bush administration's effort to push for tort reform with respect to product liability. This initiative puts to rest any doubts that FDA decision-making has become politicized," See Wall Street Journal report, Jan. 15 at:: http://www.ahrp.org/cms/content/view/34/1/ Contact: Vera Hassner Sharav 212-595-8974 veracareahrp.org Science & Integrity: Center for Science in the Public Interest Six Years of Study, And Then FDA Exempts Most Drugs from New Labeling Rules January 18, 2006 Merrill Goozner The Food and Drug Administration trotted out its long-awaited new labeling rules today, and, as expected, did a major favor for drug companies facing liability lawsuits while exempting drugs older than five years from its requirements. The purpose of the new labeling rule, the first major revision in 25 years of the package inserts given with all drug prescriptions, is to provide physicians and consumers with clear and concise information about the uses, side effects and potential dangers of FDA-approved medicines. FDA deputy director Janet Woodcock said the old package inserts containing scientific gobbledegook that most patients immediately throw in the garbage will soon be replaced with printed inserts whose information will be as easily read as the nutrition labels on food. The labels will also be posted on the web at a new website. Sounds good. But the problem is that there was nothing in the new regulation that required drug companies with products over five years old from complying with the new rule. Since the drug industry's output of new drugs has been rather low of late, the vast majority of drugs in widespread use will not be covered by the new rule. Moreover, one physician on a "stakeholders" conference call pointed out that many labels on older drugs -- he gave the example of HIV/AIDS drugs approved before the development of triple-cocktail therapy -- contain outdated information about the best uses of the drug, even if the label isn't technically incorrect. "If there is new information that causes the label to be false or misleading, then it should be revised," said Rachel Behrman, deputy director of the Office of Medical Policy at FDA. "But there is nothing in the rule requiring it." Meanwhile, as the Wall Street Journal reported last Friday, the preamble of the rule contained a clause that said states cannot pass labeling rules that demand companies print more information than the FDA requires. Many product liability lawsuits against drug companies rest on the claim that the company failed to warn about hazards because they failed to comply with state labeling statutes. One Washington law firm described the federal preemption language in the new rule as "not only an end-run around current law but also a broad extension of the Bush administration's effort to push for tort reform with respect to product liability. This initiative puts to rest any doubts that FDA decision-making has become politicized," said Ira Loss and Beth Steindecker, attorneys at Washington Analysis. When questioned by reporters, deputy director Scott Gottlieb, the Bush administration's second highest ranking political appointee at the agency, tried to downplay this gift to the drug companies. "This is just a rearticulation of a policy that the FDA has filed in various amicus briefs over two administrations,"; he said. It's true that Big Pharma has exerted extraordinary control over the FDA legal counsel office in the past decade. One of former Vice President Al Gore's top advisers hailed from Genentech, a leading biotech firm. However, this drug industry influence over legal affairs at the agency skyrocketed during the first Bush term when former industry lawyer Dan Troy assumed the top lawyer job at the agency. He is now back at his old firm representing industry clients. The revised labeling rule was initially proposed in 2000 during the waning days of the Clinton administration. That version did not contain the preemption language. Posted by gooznews at 05:49 PM http://online.wsj.com/article/SB113760135744049798.html THE WALL STREET JOURNAL January 19, 2006 Lawyers May Change Their Tactics In Drug Liability Cases By HEATHER WON TESORIERO and ANNA WILDE MATHEWS Copyright 2006 Dow Jones & Company, Inc. All Rights Reserv FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit. 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