Payments to Foreign Doctors by Manufacturers
At least a dozen drug and device manufacturers are being investigated for possible illegal payments to doctors and health officials in foreign countries. Many doctors outside the U.S. are considered government employees, and this could be a possible violation of the Foreign Corrupt Practices Act. Of great concern is the unusually large payments made to foreign doctors that oversee the growing number of clinical trials that drug and device makers conduct abroad. One investigation found that more than 80% of the drugs approved in the U.S. in 2008 involve trials in foreign countries, and 78% of all people who participated in clinical trials were enrolled at foreign sites.
http://www.nytimes.com/2010/08/14/health/policy/14drug.html?_r=1&hp
Drug Industry Lobby Having Second Thoughts
After PHRMA worked out a deal with the White House, where they made concessions worth about $80 billion over a decade in exchange for deeper cuts, they are now considering how to work out some deal or relationship with the House and possibly even the Senate after the midterm elections. This could bring up some of the ideas that were formerly dropped such as drug importation from Canada in the future.
http://online.wsj.com/article/SB10001424052748703321004575427343228372872.html
China to Improve Manufacturing Standards
Improving manufacturing policies for both food and drugs by the Chinese health officials is the result of a partnership between China and the U.S. government. The FDA is trying to formulate common standards with other governments to prevent contamination and counterfeiting of food and drugs.
http://www.google.com/hostednews/ap/article/ALeqM5hzWUQ-DZs-xHdM-lxNnqWob-0uGQD9HIGEQO0
Infections Linked to Needleless Connectors
Nine different firms have been requested to look at the possible connection between bloodstream infection rates and the use of positive displacement needleless connectors, which are used in administering some intravenous fluids. This is a result of the FDA receiving notification of three deaths linked to bloodstream infections among patients using the device.
http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/21682
Patients Still Not Getting Needed Information
A study requested by the FDA at a university showed that while 94% of patients are getting written information with their prescriptions, only 75% of them are getting information that is considered useful. The FDA has begun to work on a new rule to standardize patient leaflets and combine all the various printed information patients now get into one single document.
http://www.npr.org/templates/story/story.php?storyId=129235395
Acai Berry Scam
The Federal Trade Commission has filed suit to close down acai berry scams promising dreams of rapid weight loss that are promoted by celebrity endorsements such as Oprah Winfrey and Rachel Ray. These companies lure customers into providing their credit or debit card numbers when they sign up online for a free trial. However, month after month consumers continue to get shipments of the medication for pills that they did not want and charges of $45 to $65 on their credit cards that were billed despite their attempts to cancel this scam; customers have been bilked out of up to $100 million.
http://www.washingtonpost.com/wp-dyn/content/article/2010/08/16/AR2010081603266.html
China Modified and Approves Purchase
Novartis AG plans to acquire Alcon Incorporated. This acquisition has been approved by the Chinese Ministry of Commerce, which added conditions for the China market. This is the sixth time the ministry has subjected conditions for corporations under a two-year old anti-monopoly law that has yet to be applied to domestic corporations.
http://online.wsj.com/article/SB10001424052748703908704575433003593662286.html
Hummus and Eggs
Two recent items of interest regarding food involved eggs that were recalled due to salmonella concerns and, secondly, a report from the CDC that hummus is a top source for food borne illness. Of 21,244 illnesses in 2007, 802 were leaked to hummus, many of them specifically to one event.
http://www.usatoday.com/news/health/2010-08-18-salmonella18_ST_N.htm
http://www.walletpop.com/blog/2010/08/16/cdc-study-hummus-tops-the-list-of-foods-that-sickened-people/
J&J to Revamp Quality-Control Systems
Johnson & Johnson has announced plans to revamp its quality controls and create a single framework for its drug, medical device, and consumer healthcare divisions. J&J also say they plan to appoint chief quality officers for each of their three major divisions. J&J is concerned that consumers are wary as a result of the series of recalls and said the company would work to regain consumer confidence. It also has indicated that it would be beneficial to have a J&J-wide Operations Unit that is specifically charged with monitoring compliance with quality standards.
http://www.nytimes.com/2010/08/19/business/19drug.html?_r=2&ref=health
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