FDA Approval Given to Covidien for MS Oral Solution
Mallinckrodt has received approval from the FDA to return its morphine sulfate 20-mg/mL oral solution to the marketplace. It began marketing the 20-milligram per mL strength in 2005, but, in 2009, the FDA announced that manufacturers could keep morphine sulfate oral solution on the market but only once the product was approved. So, Mallinckrodt removed its product from the market. Covidien, based in Dublin, Ireland, which also makes medical devices and supplies, is reportedly looking for a buyer for its St. Louis-based pharmaceutical unit.
www.bizjournals.com/stlouis/news/2011/08/01/covidien-drug-gets-fda-approval.html
Non-cash Money Transfers by Lilly
$48.1 million was provided to 45,440 physicians and/or 1,827 healthcare organizations during the first quarter, most of it for research and education, by Lilly. Most of the money went to hospitals or universities to cover costs associated with running clinical trials; educational programs made up 28% of doctor compensation, according to data released by Lilly, for the first time as part of its obligations under a 2009 corporate integrity agreement with the federal government.
Lilly has been reporting fees paid to its faculty since 2009, a group which numbers between 4,000 and 5,000 physicians who do commercial speaking, consulting, and advising for the firm. A new registry now includes payments to any physician in the U.S. who received a transfer of value (TOV), including business meals, travel expenses, and other services account for the rest of Lilly's physician compensation during the quarter.
Last year, GSK paid a total of $85.3 million to more than 5,000 U.S. healthcare professionals (HCPs) for promotional talks or serving on advisory boards and to institutions for their help in conducting research; Merck said it paid $20.4 million last year to more than 2,000 U.S. doctors and HCPs.
The law lists 14 natures of payment and TOVs that need to be recorded. Except for samples, this includes everything from food and entertainment to gifts, consulting fees, and honoraria.
www.mmm-online.com/lilly-becomes-latest-pharma-to-disclose-non-cash-transfers/article/208672/
FDA Asks Congress for More Power
The FDA wants expanded power to stop medicines at the border if their manufacturers refuse FDA inspections, and the power to order mandatory recalls of unsafe products, said Deborah Autor, the agency's newly appointed deputy commissioner.
Deputy Commissioner Autor has been making these arguments for at least three years, ever since a contaminant-laced blood thinner, heparin, made its way to the U.S. from China, killing 81 people and sparking lengthy congressional hearings about the FDA's authority. During that time, Autor was director of the FDA's compliance office, making her directly responsible for unsafe or ineffective drugs.
Her new office is part of the agency's big push to transform itself into a globally focused regulator to address the increasing quantity of imported food and drug ingredients that are consumed in the U.S.
In a June report, the FDA said about half of all medical devices, 40 percent of pharmaceuticals and some 80 percent of the active ingredients in U.S. drugs are manufactured overseas.
www.reuters.com/article/2011/07/29/us-fda-autor-idUSTRE76S3T620110729
Diflucan (Fluconazole): Long-term, High-dose Use During Pregnancy May Be Associated With Birth Defects
The FDA has announced that treatment with chronic, high doses (400 to 800 mg/day) of Diflucan (fluconazole) during the first trimester of pregnancy may be associated with a rare and distinct set of birth defects in infants. These defects do not appear to be associated with a single, low dose of fluconazole 150 mg to treat vaginal yeast infection (candidiasis). Due to this, the pregnancy category for fluconazole indications (other than vaginal candidiasis) has been changed from category C to category D. The pregnancy category for a single, low dose of fluconazole has not changed and remains category C.
http://pharmalive.com/news/index.cfm?articleID=797393&categoryid=9&newsletter=1
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