[Source: Health and Life Sciences Daily, Sept. 20, 2007]
Modern Healthcare (9/20, DoBias) reports that the HHS "has unveiled a road map that would parlay current health initiatives, such as the use of information technology and evidence-based practices, into a workable system in which scientists and physicians could 'customize' the care they give to an individual based on that person's genetic makeup and other factors." The report, Personalized Health Care: Opportunities, Pathways, Resources (pdf), examines "the preliminary challenges that scientists face when they translate their growing knowledge of the human genome into the everyday practice of medicine."
Government Health IT (9/19, Ferris) noted that at a conference on personalized medicine, Health and Human Services Secretary Mike Leavitt said, "The potential is huge -- for protecting health, for preventing and pre-empting disease and for personalizing treatment according to each person's unique biology." According to the report, "personalized healthcare will support prevention of some illnesses and enable practitioners to avoid making some treatment errors."
Thursday, September 20, 2007
U.S. House passes bill to give FDA more power
[Source: Health and Life Sciences Daily, September 20, 2007]
The CBS Evening News (9/19, lead story, 2:10, Couric) reported, "Congressional negotiators have agreed on an overhaul of the Food and Drug Administration to give it more power to protect us from potentially dangerous food and medications. The bill would give the FDA the power, for the first time ever, to demand studies on the safety of drugs even after they've been approved, and the power to demand changes in drug advertisements."
The New York Times (9/20, A18, Harris) reports that on Wednesday the U.S. House of Representatives voted 405 to 7 to pass H.R. 3580, legislation that "is expected to give federal drug regulators significantly more money and power to ensure the safety of the nation's drug supply." All signs point to a Senate passage on Thursday and President Bush is expected to sign it shortly thereafter. According to the Times, "The legislation was welcomed by both industry and consumer groups, who all found something to trumpet in the mammoth bill."
Congressional Quarterly (9/20, Armstrong) notes, "Under the compromise, drug companies would pay a new user fee totaling some $225 million over five years that would fund FDA drug-safety activities. The FDA would be able to "strictly" regulate direct-to-consumer ads. The agency "would be able to review drug ads and fine companies for false or misleading ads, but it would not be able to ban them, even temporarily." Furthermore, the agency could force drug manufacturers to conduct follow-up safety studies after a drug has been approved," and "would also have the authority to require changes to drug labeling and levy fines for non-compliance."
Bloomberg (9/20, Blum) reports, "Companies that violate FDA orders on labels and studies or certain other requirements could face maximum fines of $250,000 for a single violation and $10 million for multiple failings handled in one proceeding. The top fines are less than the House had previously approved." Bloomberg continues, "The legislation includes a compromise that would place new conflict-of-interest restrictions on participants in advisory panels used by the FDA to review drugs and devices," requiring "the FDA to decrease the number of participants with conflicts by five percent a year. The House had previously approved a limit of one conflict per committee meeting."
The AP (9/20) adds, "Stripped from the bill was a bid by Democrats to limit to three months, from the current six months, in additional patent protection blockbuster drugs can gain if their manufacturers study their use in children. The stripping of even three months of protection from generic competition could spell several hundred million dollars in lost revenue for the makers of drugs with sales that exceed $1 billion a year."
The Wall Street Journal (9/20, A6, Mathews, et al.) reports, "The final bill includes a provision backed by House Democrats that could weaken a key legal defense that pharmaceutical companies have used in plaintiff suits. The debate centered on the question of drug companies' protection against plaintiffs claiming that they were injured by medicines. The Bush administration has backed the idea that FDA-approved drug labels pre-empt state law," and many pharmaceutical companies "have used that as a shield in legal cases, arguing that they weren't required to warn consumers about a potential risk if the FDA determined that the safety issue didn't warrant inclusion in the label." However, the newly passed FDA bill "includes language that could limit that protection, by saying that drug companies have a responsibility to maintain their labels, thus leaving the manufacturers potentially liable if they fail to make changes even without the FDA's explicit approval." Gerie Voss, regulatory counsel for the American Association for Justice, "said it supported the House language because it is 'still putting the onus on the drug companies to let the public know when there is a potential drug hazard.'"
The CBS Evening News (9/19, lead story, 2:10, Couric) reported, "Congressional negotiators have agreed on an overhaul of the Food and Drug Administration to give it more power to protect us from potentially dangerous food and medications. The bill would give the FDA the power, for the first time ever, to demand studies on the safety of drugs even after they've been approved, and the power to demand changes in drug advertisements."
The New York Times (9/20, A18, Harris) reports that on Wednesday the U.S. House of Representatives voted 405 to 7 to pass H.R. 3580, legislation that "is expected to give federal drug regulators significantly more money and power to ensure the safety of the nation's drug supply." All signs point to a Senate passage on Thursday and President Bush is expected to sign it shortly thereafter. According to the Times, "The legislation was welcomed by both industry and consumer groups, who all found something to trumpet in the mammoth bill."
Congressional Quarterly (9/20, Armstrong) notes, "Under the compromise, drug companies would pay a new user fee totaling some $225 million over five years that would fund FDA drug-safety activities. The FDA would be able to "strictly" regulate direct-to-consumer ads. The agency "would be able to review drug ads and fine companies for false or misleading ads, but it would not be able to ban them, even temporarily." Furthermore, the agency could force drug manufacturers to conduct follow-up safety studies after a drug has been approved," and "would also have the authority to require changes to drug labeling and levy fines for non-compliance."
Bloomberg (9/20, Blum) reports, "Companies that violate FDA orders on labels and studies or certain other requirements could face maximum fines of $250,000 for a single violation and $10 million for multiple failings handled in one proceeding. The top fines are less than the House had previously approved." Bloomberg continues, "The legislation includes a compromise that would place new conflict-of-interest restrictions on participants in advisory panels used by the FDA to review drugs and devices," requiring "the FDA to decrease the number of participants with conflicts by five percent a year. The House had previously approved a limit of one conflict per committee meeting."
The AP (9/20) adds, "Stripped from the bill was a bid by Democrats to limit to three months, from the current six months, in additional patent protection blockbuster drugs can gain if their manufacturers study their use in children. The stripping of even three months of protection from generic competition could spell several hundred million dollars in lost revenue for the makers of drugs with sales that exceed $1 billion a year."
The Wall Street Journal (9/20, A6, Mathews, et al.) reports, "The final bill includes a provision backed by House Democrats that could weaken a key legal defense that pharmaceutical companies have used in plaintiff suits. The debate centered on the question of drug companies' protection against plaintiffs claiming that they were injured by medicines. The Bush administration has backed the idea that FDA-approved drug labels pre-empt state law," and many pharmaceutical companies "have used that as a shield in legal cases, arguing that they weren't required to warn consumers about a potential risk if the FDA determined that the safety issue didn't warrant inclusion in the label." However, the newly passed FDA bill "includes language that could limit that protection, by saying that drug companies have a responsibility to maintain their labels, thus leaving the manufacturers potentially liable if they fail to make changes even without the FDA's explicit approval." Gerie Voss, regulatory counsel for the American Association for Justice, "said it supported the House language because it is 'still putting the onus on the drug companies to let the public know when there is a potential drug hazard.'"
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