With the recent sweeping victory of the Republicans, it seems that a natural target in the political landscape will be to attempt to remove the Affordable Care Act or what they deem as “Obamacare.” What does this mean within the industry? Well, let’s look at what might be the future of Obamacare. First, the Republicans [...]
According to Vermont Senator, Bernie Sanders (I-VT), the prices of more than 1,200 generic medications increased an average of 448 percent between July 2013 and July 2014. This does not seem logical to the law maker as generic drug manufacturing companies don’t have the high investment in research and development and marketing that impact other [...]
Ebola is all over the news with cases now being reported in New York. The medical community is working hard to combat Ebola along with political interventions and policy changes such as restricted flights and quarantining of visitors returning from certain locations. Here is a quick list of five pieces of information about Ebola. 1: [...]
Posted on 25. Nov, 2014 by Karl Kapp.
Recently, several Medical Device companies have been making the news for some record settlements, recalls and court cases: Stryker, the artificial hip implant company, announced that it has reached a settlement of thousands of lawsuits related to those who claimed to be injured by a hip replacement in which the replacement’s ball and cup components [...]
Posted on 19. Nov, 2014 by Karl Kapp.
Many groups within organizations look to performance measures to determine the impact of an initiative. Sales teams look at sales numbers, number of calls and volume of product sold. Manufacturing organizations look at the quality of goods produced, number of goods produced and safety of employees during the production process. It only makes sense that [...]
The commissioner of the FDA, Margaret A. Hamburg, M.D., recently released an announcement concerning strategic priorities for the FDA. The announcement is available here. In the announcement, Hamburg indicated that the FDA is focusing on what it calls, “five cross-cutting strategic priorities.” These priorities are: Regulatory Science Regulatory science is the science of developing new [...]
The FDA recently announced an online tool to provide insight into its compliance, inspection, and recall activities. The tool represents a departure from the downloadable spreadsheet-based datasets the FDA previously provided. Instead, the FDA data dashboard presents information in an easy-to-read graphical format. It also provides access to the underlying data allowing anyone interested to [...]
The manufacturing of quality medicine is an important issue for the world and recent lapses in India are causing concern. According to the New York Times, India is the second-largest exporter of over-the-counter and prescription drugs to the United States. And the country is coming under increased scrutiny by American regulators for safety lapses, falsified [...]
Companies, doctors and individuals who ignore compliance issues and GMPs, or mislabel products continue to face stiff penalties and even jail time. Here are some examples of recent infractions and associated penalties. A rheumatologist in Mayfield Village, Ohio was sentenced to probation for importing medications that had not been approved by the Federal Drug [...]