McNeil Consumer Healthcare September 2008Recall: Tylenol Arthritis Relief Caplets October 2008Recall: Infants Mylicon Gas Relief November 2008BLAME PALLETS December 2008“Phantom Recall” Adult Motrin January 2009Recall: Tyelnol, Motrin, St. Joseph’s Aspirin April 2009Consumer Complaints: 39 odor; 3 adverse events; November 2009Recall: Tylenol Arthritis moldy odor, nausea, stomach pain December 2009Recall: Tylenol Arthritis Pain Caplets January 2010 Recall: Motrin, Benadryl Allergy, Rolaids, Simply Sleep, St. Joseph FDA issues Puerto Rico report May 2010 FDA completes 12-day inspection/investigation of Ft. Washington Ft. Washington Plant ceases production August 2010Recall: 100,000 boxes of 1-Day Acuvue TruEye Contact Lenses September 2010Hearings: House Committee on Oversight & Government Reform November 2010Recalls more drugs produced at Ft. Washington Plant December 2010 Recall: 13-million packages of Rolaids Recall: Expands August recall of Acuvue Contact Lenses
Congressional Hearing FDA Dep. Commissioner Lists J&J Failures –Miscalculating and/or misstating risks and benefits of products –Particulates found in liquid medications –Failure to meet its own specifications for bacteria and particulates –Higher than expected concentrations of Tylenol per dropper –Bacteria contamination of raw materials –Inadequate equipment maintenance –Failure to investigate consumer complaints of foreign materials, black or dark specks made a year before recall Smelly Pallets
Food and Drug Administration DOT vs. FDA Writing Regulations –Trucks and Trains –Banning Products
NWPCA Comments Wood is Good –Natural product –Used as food component –Favored kitchen utensil Wood vs. Plastic –New –Used
NWPCA Proactive Proposal A visual inspection should be conducted to assure recycled pallet components are dry and clean with no observable dirt, debris or animal droppings. If any dirt, debris, or animal droppings are detected, they should be removed. Visible inspections should include examining pallets for protruding nails or other visible defects as needed.
Food Modernization Act $1.4 billion Requires large farms and food producers to create in-depth food safety plans. Grants the government new powers to inspect food-production facilities and order recalls. Field-to-Fork Momentum
111 th Congress Tax Rate Extension Estate Tax Reinstated
The Patient Protection and Affordable Care Act (PPACA) Small business tax credits (2010-2014) Insurance coverage value reporting (2011) Lower limits on flexible spending accounts (2013) Employer coverage & penalties (2014) Taxing cadillac plans (2018)
Health Insurance Reform Repeal Efforts Congressional Actions –Repealing the Job-Killing Health Care Law Act –Piecemeal Approach Judicial Actions
112 th Congress Debt Level –$14.29 trillion –$1.9 trillion –$148.2 billion – 1 st Q Debt Payment Pass Budget
“As the Political Pendulum Swings” 1993 Democrats voted to give vote 1995 Republicans reversed 2007 Democrats reversed Republicans 2011 Republicans again eliminated vote
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