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HERE ARE THE 5 MYTHS ABOUT ORPHAN DRUGS & THE ORPHAN DRUG ACT
Treatments for rare diseases - conditions that affect fewer than 200,000 Americans - are called "orphan drugs because historically, these conditions have been ignored, or "orphaned, due to the small populations of people impacted by them.
FACT: These drugs have multiple indications - and are not just sold as orphan drugs. This means they have been approved to treat multiple conditions, not just rare diseases. Therefore, their total sales figures are the sum of both their orphan and non-orphan indications.
FOR EXAMPLE: Humira, which is frequently cited, has 12 different indications, only 4 of which are orphan. Of its $13.6 billion in total sales in 2016, only 3.8% were attributed to the four orphan indications.
Blockbuster drugs can be protected from competition by seeking an added orphan indication to an already approved drug, and the benefit of market exclusivity applies to all of the drug's indications
Orphan drugs are a major contributor to rising drug and healthcare costs
FACT: Of the total drug sales of $450 billion in the US in 2016, only 7.9% were for orphan indications of approved drugs.
Specialty drugs are the same as orphan drugs
FACT: The two are not the same. Specialty drugs are defined by special requirements (i.e., for storage or handling); how they are administered (i.e., by a professional or as an infusion); and how much they cost. While an orphan drug may be a specialty drug, not all specialty drugs are orphans.
FACT: Studying rare diseases has led to increased understanding of the body's biochemical pathways and to major breakthroughs in discovering how our genes interact with other factors to cause disease. The Orphan Drug Act has helped drive innovation in many fields within medicine, including cancer treatment.