Few industries evoke an emotional response greater than the pharmaceutical industry. This cannot be surprising, since drug companies are typically viewed by the public as either providing miraculous life-altering therapies, or greedy instruments of Satan. There is little middle ground.
So, it is rather surprising that a new law, called the 21st Century Cures Act, has been overwhelmingly approved by the House, 344-77 on July 10th.
The new law, also known as H.R. 6, gives more latitude to the FDA in tailoring its safety and efficacy requirements for the approval of breakthrough medicines. Such drugs (as well as breakthrough medical devices) that are given this designation will no
drug prices
John LaMattina, the former head of R&D at Pfizer, tackles a timely and important topic in his Forbes piece today: What is the best way to do oncology research? And, can it save money as well as lives?
It is rare when a single drug entirely revolutionizes the treatment of a disease. Yet, Gilead s Sovaldi did just this, following its FDA approval in late 2013.
In the public gets the shaft again department, there is yet another example of a failure of generic drugs to control healthcare costs one that would make companies like Pfizer, Merck, and the others green with envy.
And, of course, it s all about green, and we don t mean recycled shopping bags.
In today s you could have predicted this department, we are going to take a look back at the rather naive mindset of the American public that took center stage about five years ago.
At that time, the pharmaceutical industry was facing the patent cliff the loss of the patent life of some of the best selling drugs. Once the patent of the original discovery expires, any company is then free to manufacture the generic version of the same drug the next day.
If you are looking to have a rational discussion about the value of pharmaceuticals rather than just the cost, you should avoid Vermont.
The Biotechnology Industry Organization (BIO) has taken issue with a recent 60 Minutes piece about the high price of new oncology drugs.
The BIO response was It is unfortunate that CBS has chosen to attack the price of specialty cancer medications while ignoring the value created by these drugs for patients and the health care system. Cancer patients today are able to live longer and enjoy a higher quality of life than ever before thanks to medicines made by biopharmaceutical research companies."
As of mid-November of this year the FDA had approved 27 new drugs. Seven more are expected to receive approval by the end of 2013. Assuming this is correct, the total will fall short of the 41 approvals in 2012. But the trend of what is being marketed and the pricing of the products continues.
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