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It is very exciting here in Washington. The Inauguration of President-Elect Obama will take place on Tuesday and the Mall is being converted. The city is giddy. It will be a four-day weekend for many.
And here is a bit of what happened in our world this weekend.
- Lilly Resolves Investigations of Past Zyprexa Marketing and Promotional Practices – Eli Lilly and Company announced that it has reached resolution with the United States Attorney for the Eastern District of Pennsylvania (EDPA) and the Office of Consumer Litigation of the Department of Justice regarding the previously-reported government investigation into the company's past U.S. marketing and promotional practices for the antipsychotic medication Zyprexa(R) (olanzapine). As part of the resolution, Lilly has agreed to plead guilty to one misdemeanor violation of the Food, Drug, and Cosmetic Act. The company will also enter into a settlement agreement resolving the federal government's civil investigation. Even though the company disagrees with and does not admit to the civil allegations, the company has agreed to settle the dispute over these allegations. In addition, the company has agreed to settle civil investigations brought by the State Medicaid Fraud Control Units of the states that have coordinated with the EDPA in its investigation.
- HHS Gives $486 Million Contract to Novartis for Pandemic Flu Vaccine Facility – The contract will support the design and construction of a new facility in Holly Springs, North Carolina to provide capacity to create a supply of 150 million doses of vaccine within 6 months of a pandemic declaration.
- HHS Opens U.S. Food and Drug Administration Offices in India – HHS/FDA will post 10 experienced officials in India to work closely with industries that ship food and medical products to the United States, to improve safety and quality, which will facilitate the smooth flow of trade. Along with the Office Director, HHS/FDA will have four inspectors and five senior technical experts who will cover food, medical devices and medicines.
- GAO Outlines Steps FDA Needs to Take in Device Approval - The Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS) is responsible for oversight of medical devices sold in the United States. Regulations place devices into three classes, with class III including those with the greatest risk to patients. Unless exempt by regulation, new devices must clear FDA premarket review via either the 510(k) premarket notification process, which determines if a new device is substantially equivalent to another legally marketed device, or the more stringent premarket approval (PMA) process, which requires the manufacturer to supply evidence providing reasonable assurance that the device is safe and effective. Class III devices must generally obtain an approved PMA, but until FDA issues regulations requiring submission of PMAs, certain types of class III devices may be cleared via the 510(k) process. The FDA Amendments Act of 2007 mandated that GAO study the 510(k) process. GAO examined which premarket review process—510(k) or PMA—FDA used to review selected types of device submissions in fiscal years 2003 through 2007. GAO reviewed FDA data and regulations, and interviewed FDA officials.
- Sidney Wolfe Speaks Out About His Role on FDA Advisory Committee – Many have been struck by the recent inclusion of industry critic and perennial fixture at FDA Advisory Committee meetings Dr. Sidney Wolfe from Public Citizen to sit on the Drug Safety and Risk Management Advisory Committee. While many have expressed thoughts on this, here is Dr. Wolfe expressing his own with the Wall Street Journal:
