FDA: Going on defense..Is it hurting or helping patients?
Aug/17/2007 07:22 Filed in: Pharma
Business
There is no doubt that the drugs that have been approved over the last decade have help millions of people worldwide lead better lives. There always will be some risk associated with new drugs that are approved as continuing clinical trials may indicate more and more severe side effects. However is the FDA balancing the risk of approval of new drugs with the need by patients? "They've raised the bar," said a recent analyst. "They've made it more difficult for drugs to get through the system. The FDA has been pretty much playing defense since 2004." By playing defense though patients may not be able to go on the offensive against diseases that can severely restrict their ability to live a better quality of life.
This year's approvals include only seven drugs that can be considered completely new, which is a 10-year low for the industry. These "new molecular entities," as they are known in FDA parlance, work in a completely different manner than drugs that are already on the market. "[New molecular entities] are the break-though drugs that really start to carve out a new path, as opposed to combinations of existing drugs," said an analyst.
Of course the other side of the coin is that the pipeline in pharma is drying up. Amgen, for example, announced that it would be cutting R&D spending as a result of recent troubles with it's drug Aranesp. Lilly is betting on a drug to compete with Plavix and Pfizer is trying to gain additional patent protection on its blockbuster Lipitor. Rest assured though that drugs currently in clinical trials are going to need additional clinical trials to get through the tougher FDA approval process adding millions of dollars in development costs.
The FDA needed to exert some leadership but in response to political pressure they have gone from one extreme to the other. They need to first start with an addition to fair balance on all newly approved drugs that warns that although these drugs have been approved ongoing clinical trials may highlight some additional side effects that did not come to light in clinical trials for approval. This would both warn patients and let them decide if the risks are acceptable. The environment has changed and it's time for pharma to be proactive instead of reactive. This included more transparency with consumers and patients in ALL DTC activities.
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