Amid rising concern over prescription drug pricing, Senator Chuck Grassley (R-Iowa) has begun an investigation into whether drug makers are exploiting loopholes to widen the market for so-called orphan drugs.
The move comes after accelerating scrutiny of this lucrative corner of the pharmaceutical market. Under the Orphan Drug Act, which was passed in 1983, the Food and Drug Administration began approving medicines to treat rare diseases that affect fewer than 200,000 people. The incentives to fill these unmet medical needs include tax credits and seven years of exclusive marketing rights.
Consequently, companies typically charge of hundreds of thousands of dollars per year for each patient. For instance, Biogen is charging $750,000 for the first year of treatment, and $375,000 each year thereafter, for a new drug for spinal muscular atrophy. And Sarepta Therapeutics is charging $300,000 or more, depending upon patient weight, for a drug to combat Duchenne muscular dystrophy.
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ODA is racket of PhRMA and politicians who are on sale.
PhRMA should not feel bad. They are the ones who bought the legislators to benefit from every corner. Since 1983 when the ODA was passed 5,732 drugs have been requested orphan drug status. 3,986 drugs were given the status and 599 have been approved. In recent years most of them are priced in six digits. Whole idea is to make money and fill their pockets. Poor patient is going to die sooner or later. Who cares if that happens. Normal process of living.
Point is make drugs affordable but not at the expense of patient and their family.