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There are 2 sides to the coin he ...

Posted Nov 10 2008 4:18pm

There are 2 sides to the coin here – Safety and effectiveness and both need to be weighed before an approval can take place.  Granted there is more research going on now with drugs and biotechs than what has ever occurred in history, so there are more areas for the FDA to look at before an approval is granted.  image

The FDA is not unlike any other industry today being deluged with more information and a method to mine, analyze and report results.  What makes the FDA more unique though is the fact that our lives depend on their decisions.  Technology has accelerated research in the last few years and brought many more complex scenarios to the table, and we have yet to fully embark on personalized medicine.  With a deluge of information, sometimes things are potentially missed or overlooked.  With technology today, many of such items can quickly be reviewed, thus when drug companies look at medications on the market today, they can in fact identify other added or non beneficial elements to the effectiveness of the drug.  One of the most famous cases of this of course is Viagra, originally slated for heart disease and we all know where this has gone. 

Research and the associated costs is not getting any cheaper either.   Costs for biometrics can be expensive, depending on the research being conducted, so yes there is a desire for a return on investment with R and D costs, and nobody wants to have to close shop and start over, although there are cases where the drug has not been determined to be effective and that happens but not without financial consequences.  There are no guarantees with research and thus the FDA is our government agency that has the power to give a yes or a no to whether or not it can be approved for use. 

With as complicated as things have become today, it’s not a bad idea for the FDA to be a little more strict, require additional facts, so they can in fact make the right decisions, and there will always be disputes on what they should approve sooner as well.   Drug companies need a return on investment, thus today they too are also watching expenses and studies on current therapies are most of the time less expensive than starting with a brand new drug, thus we see more drugs being investigated for additional benefits to be derived.  Start up companies are usually more aggressive these days with new drugs and then later are consumed by the major pharma companies and this process is more than likely to continue as you see more pharma investments going over to the biotech side. 

The FDA can’t be faulted for wanting to ensure safety these days as they have been under fire recently for a number of issues and the direction now appears to be making the effort to get things back on track with safety being the number one priority, along with approving a drug or device that is in fact going to work in the interest of both treatments plans and potentially life saving benefits.  Myself, I’m just glad they are investing and getting some of the new technology they need for better decisions, a while coming.  BD 

An "intensifying focus on safety and a diminished tolerance for side effects" by FDA have "dramatically lowered" the chances that experimental medications will reach the market and have led to a recent decrease in approvals of new treatments, according to pharmaceutical companies, the Wall Street Journal reports. Last year, FDA approved 19 new medications -- the fewest in 24 years -- and announced about 75 new or revised "black box" warnings, twice the number announced in 2004, according to a division of Sagient Research Systems. In addition, the number of approvable letters, which in most cases require pharmaceutical companies to submit additional clinical data before FDA will make a decision on whether to approve experimental medications, increased by 40% last year.

Pharmaceutical companies say new approach by FDA has led to decrease approvals of new medications

Technorati Tags: FDA, Pharma
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