Lobbyists focus on safety in debate over generic drugs
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WASHINGTON -- Biotechnology lobbyists attempting to slow the development of cheap generic versions of the world's most expensive drugs have been emphasizing questions about their safety in an effort to win support among the new Democratic leaders of Congress.
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Stung by a crackdown on unproven claims about the safety and effectiveness of medications made by pharmacies to treat menopause, supporters of the drugs have launched a lobbying campaign aimed at the Food and Drug Administration.
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Government regulators now look to approve as quickly as possible medicines whose benefits exceed their risks.
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Critics charge conflict of interest in a system where pharmaceutical giants fund the regulatory process. By Alexandra Marks | Staff writer of The Christian Science Monitor.
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Debate about the safety of a group of  anemia drugs widely used in cancer patients should focus on a  minority of patients who got the drugs for unapproved uses,  doctors said on Sunday.
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As drug advertising aimed directly at consumers becomes more widespread and controversial, the issue will likely have political implications.
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The US Food and Drug Administration on Friday asked an outside group to review the way it monitors safety risks associated with medicines already on the market, such as Merck &amp; Co.
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The FDA decides to debate the company's lead drug.
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Drug makers are worried that calls  for greater disclosure of early-stage clinical trials might  lead to the release of scientific information that could help  competitors, an industry lobbyist said on Monday.
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Despite calls from medical experts and a prominent Republican senator for an independent office to monitor drug safety, the idea, prompted by the Food and Drug
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Many drug company lobbyists concede that the House is likely to pass a bill intended to drive down drug prices, but they are determined to block such legislation in the Senate.
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A series of drug-safety scandals has led many on Capitol Hill to question whether the F.D.A. has failed to strike the right balance between speed and safety.
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British drug firms have defended the safety of two products which were deemed unsafe by an American expert. Dr David Graham listed five medicines which he said posed serious health risks during a US Senate hearing.
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Congress is looking into whether the Food and Drug Administration ignored safety concerns about the drug raised by its own reviewers and outside scientists.
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Lobbying and other political spending by the pharmaceutical industry includes:
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The U.S. Food and Drug Administration on Friday asked an outside group to review the way it monitors safety risks associated with medicines already on the market, such as Merck & Co. Inc.'s withdrawn painkiller Vioxx.
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Congress ought to write a detailed prescription for change in US oversight of drug safety. The public deserves better protection from potentially dangerous new medicines.