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Orphan Drugs and FDA Approval

Posted on April 3, 2016

Pharmaceutical companies make money by developing and marketing medications that are needed by millions of people. This helps them make back the expensive costs and research that goes into creating a new drug. So, there is little or no incentive for a pharmaceutical company to develop medications for diseases that only afflict a few hundreds or thousands of people. Diseases that only effect a small number of people are commonly referred to as “orphan diseases.”

To encourage pharmaceutical manufacturers to develop medications for orphan diseases, Congress passed the Orphan Drug Act of 1983 (ODA). The ODA offers incentives such as grants and tax incentives to companies that develop drugs for people suffering from orphan diseases. The ODA also extends the exclusive marketing rights period for orphan drugs to seven years, as opposed to the usual five years for non-orphan drugs. The ODA also streamlines the approval process from the U.S. Food and Drug Administration (FDA). But, as the old saying goes, “The road to hell is paved with good intentions.”

Many pharmaceutical companies will develop medications as orphan drugs, utilizing the tax incentives, grants, and the ODA’;s streamlined approval process, only to market these drugs for wider use later. This allows drug companies to develop and get approval for medications for a relatively low cost. It also increases the possibility of a drug being approved without thorough testing, and gives the company more time to make money off the drug before a generic version can be made available.

If you or a family member has been injured or suffered a side effect from taking an orphaned drug, you or they may be able to pursue compensation for certain damages. To find out if you have a viable injury claim, call the law offices of Farah & Farah for a free consultation. We are now investigating pharmaceutical litigation injury claims nationwide.

Contact us at (800) 533-3555.