Wednesday, October 11, 2017

FDA Looking Into Faster Generic Drug Development to Help with Rx Prices

The only way you wouldn’t know that prescription drug prices are spiraling into the stratosphere is if you haven’t needed a prescription in the last 5 years.  Many patients are faced with financial dilemmas such as “food or medicine” simply because their monthly prescription prices are so high.  Of course, the one way to fight that problem is with generic medications.  Generics are frequently many orders of magnitude less than their name brand counterparts.
What has always been the case in the world of pharmaceuticals is that big pharma spends a huge amount in developing a new drug.  The costs associated with this are astronomical.  There is research and development, FDA approval, and clinical testing, just to name a few.  Due to these huge expenditures, the big pharma companies have been able to recoup their costs by having a patent lasting about 7 years.  During that time, only the original name brand drug is available and the price is high to give the company a return on their huge investment.  Once the patent expires, generics come on the market and profitability for the drug’s developer drops accordingly.
Now comes word from the FDA that they are working to expedite the development of generics on a faster track than ever before.
In a FDA blog post last week, FDA Chairman Dr. Scott Gottlieb made the following statement:
Our plan has a number of different domains. Among them is a compilation of efforts to improve the efficiency of the generic drug approval process; and another is a group of policies aimed at closing loopholes that allow branded drug companies to game our rules in ways that forestall the generic competition that Congress intended. One important group of policies is aimed at making it easier to bring generic competition to a category of branded drugs known as complex drugs. Today we’re announcing a major new set of policies to advance these goals.
The full blog post can be seen here, but you need to scroll down to the post from October 2 titled “Reducing the Hurdles for Complex Generic Drug Development”.

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