Regulatory Environment

Fees and other financial incentives

moneyponk
Twelve of the 26 researchers involved disclosed they had received fees or other financial support from manufacturers of the monitoring devices. This is at the end of a story on continuous glucose monitors and diabetics that appeared in today's Wall Street Journal. Fees? Other financial support? The question arises again "should researchers take money from the companies whose product they are researching? " Read More...
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FDA releases lists of drugs under scrutiny

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The government on Friday began posting a list of prescription drugs under investigation for potential safety problems, in an effort to better inform doctors and patients. The first list is a bare-bones compilation naming 20 medications and the potential issue for each. It provides no indication of how widespread or serious the problems might be, leading some consumer advocates to question its usefulness, and prompting industry worries that skittish patients might stop taking a useful medication if they see it listed. What are consumers expected to think from this list? There is not much information and a trip to the doctors office could take weeks and then there is the chance that physicians won't anything about the potential issue. If the FDA is trying to scare people from taking their medications they are doing a great job. Read More...
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FDA announces two new web sites on Medical Product Promotion

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On Tuesday, Sept 2, FDA launched two new Web sites to provide information for consumers and industry about how FDA regulates the promotion of medical products. The “Advertising Prescription Drugs and Medical Devices” Web site provides a “one-stop shop” portal to information on FDA regulation of medical product promotion. Industry and policy users can get directly to relevant laws, regulations, and guidances. This site can be found at The direct-to-consumer (DTC) Web site, “Be Smart about Prescription Drug Advertising: A Guide for Consumers” is designed to educate consumers about how to view such advertising to help inform their discussions with healthcare providers, and consequently to help improve patient understanding and medical care. Read More...
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Gardasil causing adverse events or is it just the patient population

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According to a video report on CNN.com, there have been 9,749 adverse events and 21 deaths from Gardasil since 2006. Rather than reassure the patient population Merck issues the following statement “Merck has analyzed the adverse events reported for GARDASIL relating to the recent reports of death and paralysis, and based on the data available to Merck, believes that no safety issue related to the vaccine has been identified. These types of events are events that could also be seen in the general population, even in the absence of vaccination. An adverse experience report describes an event that occurred after vaccination and does not necessarily mean that the vaccine caused or contributed to the event. The vast majority of adverse events that have been reported to Merck are non-serious and the most common include dizziness and syncope (fainting). Read More...
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Throwing in the towel and retreating

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If you believe that DTC serves a purpose, to inform patients and consumers about treatment options and be proactive in their healthcare choices, than the agreement of some drug makers to limit DTC for new products for six months after approval is a copout and stinks of executives who are not willing to walk the walk and talk the talk when it comes to DTC. This is a bad agreement for everyone but perhaps the biggest losers in this agreement are consumers. Read More...
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