R&D production in the pharmaceutical industry has fallen more than 70% over the last 15 years, according to a recently published report, “Beyond the Shadow of a Drought: The need for a new mindset in pharma R&D,” by a group of analysts at the Oliver Wyman consulting firm. According to this insightful analysis, the underlying causes have not seemed too alarming because pharmaceutical companies still continue to have net incomes of 20% to 30%, and the industry has sustained a 6% annual growth even during the current global economic turmoil. Continue reading
The medical device industry is rife with the exploration and development of new ideas and treatments for a startling array of health conditions. In some areas, however, medical device companies lag behind other sectors of the American economy, in particular, the number of companies that have adopted a social media strategy. Continue reading
If any part of your life includes trying to figure out how to work smarter with the FDA, this is for you. Here’s our list of the top
40 31 online destinations on the FDA and some of the key industries it regulates. We applied only one criteria to make it on this list: free, up-to-date, and valuable content. Continue reading
We live in a news-driven world, and sometimes it’s like drinking out of a firehose. So, to save time, here were some of the key developments related to the FDA over the last month.
- FDA vs. no FDA. Commissioner Hamburg wrote an elaborate piece on Innovation, Regulation, and the FDA, essentially justifying the existence of the FDA. Well-written and rich in lessons from history. For better or worse, the FDA usually gets a big boost in funding and responsibilities every time there is a big health outbreak or crisis. Only then is it politically tenable. And only then do we not take for granted the safety of the products we put in our bodies. Speaking of which, the Food Safety Modernization Act was passed, or was it? Odds are it will be passed in the next week. Continue reading
It’s been quite a year or two at the FDA since Commissioner Hamburg took over. Of particular interest to me is their increasingly tough stance on inspections and marketing issues. Here are some highlights:
- The FDA wants to prosecute pharma and device execs should their firms engage in off-label marketing. With what is known as the Park Doctrine, execs could face up to a year in jail + $100,000 fines. This would be on top of the billion-dollar+ fines the companies have paid (which have not dissuaded them from trying to get away with things). Continue reading