Expanded Approval of Humira by the FDA Allows for Extended Monopoly
A story recently covered by Healthday news talks about the recent expanded approval of the drug Humira which is used to treat the psoriatic arthritis. Psoriatic arthritis is a combination of psoriasis and arthritis where those affected experience symptoms of joint pain and inflammation, as well as red lesions on the skin.
Humira has also been approved to treat moderate to severe rheumatoid arthritis as well as an inflammatory disease of the spine called ankylosing spondylitis.
The most recent approval by the FDA was to slow and structural joint damage in people with psoriatic arthritis. The recent clinical testing of 313 people affected with psoriatic arthritis were given Humira and showed significantly less joint damage than participants that received a placebo.
My question is why wasnít Humira approved for some of these other uses when it was first released? Because market exclusivity rights granted by the FDA to drug companies run out after 7 years. That means during the seven years when it has the rights, the FDA will not allow any other drug to market itself under the same category, essentially giving in this case Humira, a monopoly for 7 years. After the exclusivity rights expire, drug companies retest their drug for a slightly different uses, and get another monopoly for 7 more years. Drug companies donít test all aspects of the drugs simply to extend its patent life in order to make more money.
Should sufferers of any illness have to wait several years to find out what a drug is actually capable of treating? Sure there are some cases where you stumble on to an alternative use years down the road, but in most instances, its just big pharmaceutical companies trying to get the most bang for their buck.
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