FDA May Seek Criminal Penalties Against J & J For Faulty Recall Of Children’s Tylenol, Other Medicin…
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Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Pharma Industry / Biotech Industry ; Pediatrics / Children’s Health ; Public Health
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The Wall Street Journal : “The Food and Drug Administration aforesaid it is deliberation whether to try condemnable penalties against the Johnson & Johnson whole that made children’s Tylenol and otc otc kids’ medicines recalled finish month. Joshua Sharfstein, the FDA’s head lieutenant commissioner, told lawmakers at a earreach Thursday that J&J’s McNeil Consumer Healthcare whole had a ‘normal of disobedience’ with effective fabrication practices. … Dr. Sharfstein aforesaid the delegacy was now workings comfortably with J&J and its McNeil whole, but he described a account of troubles acquiring the whole to fix violations” (Dooren and Rockoff, 5/28).
The Los Angeles Times reports that Sharfstein “characterized Johnson & Johnson’s bodied cultivation as decelerate to reply and not invariably afford approximately its actions. In improver to finis month’s recollection, the caller pulled 8 meg bottles of children’s medications off the marketplace in September 2009 because of a quality-control exit. … In one antecedently unrevealed showcase, Johnson & Johnson well-educated in 2008 of a potential trouble with its Motrin nuisance fireman but, rather of recalling it, leased a declarer who sent masses out to buy up the ware without revelation what they were doing. Buyers were instructed to “only ‘act’ wish a fixture client. … THERE MUST BE NO MENTION OF THIS BEING A RECALL,” according to an direction canvas obtained by House investigators” (Zajac, 5/28).
The Hill : “House Democrats on Thursday repeatedly called for federal regulators to be minded the assurance to think drugs. Pending lawmaking would assignment that exponent to the Food and Drug Administration for nutrient, but not for drugs. Statements from lawmakers at a empanel audience Thursday made it open many Democrats wishing to go farther” (Pecquet, 5/27).
CongressDaily : “Some of those expanded powers [hinted at in the earreach] admit mandatary tone systems and reminiscence authorization, admittance to sealed society records, and the power to outlet polite money penalties. FDA representatives would not direct say the authority precious expanded assurance, alternatively locution the subject was organism worked on by the government” (McCarthy, 5/27).
This data was reprinted from kaiserhealthnews.org with form permit from the Henry J. Kaiser Family Foundation. You can scene the stallion Kaiser Daily Health Policy Report, research the archives and mark up for e-mail speech at kaiserhealthnews.org .
© Henry J. Kaiser Family Foundation. All rights reserved.
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