Orphan Drug Tax Credit : Living with "Rare"

 Living with "Rare"

A blog devoted to navigating and analyzing life with 
Rare and Complex Disorders.



Orphan Drug Tax Credit

by RNE submissions on 12/04/17

By Joanna Mechlinski

You’re a person living with a rare disease or disorder, chronic and potentially life-threatening. You desperately need medication to maintain your quality of life. But perhaps your disease is so rare that there is little incentive for a pharmaceutical company – which is, after all, for-profit – to invest the time and money into developing a drug.

That’s where the Orphan Drug Tax Credit comes in. Since 1983, the U.S. has offered pharmaceutical companies reimbursement on 50% of clinical testing costs, giving pharmaceutical companies an incentive to experiment with new medications for rare diseases, which are defined in the U.S. as any that affect fewer than 200,000 people. (In Europe, it is one that affects fewer than 1 in 2000 people.) In the years since the credit’s inception, the Food & Drug Administration (FDA) has approved nearly 600 orphan drugs. Comparatively, between 1973 and 1983, only 10 drugs were approved.

There are an estimated 7,000 rare diseases – often called “orphans” due to pharmaceutical companies’ reluctance to adopt them - affecting 25-30 million Americans.

In early November, House Republicans proposed eliminating this credit. After considerable negotiation, it was decided to keep the credit but lower it to 27.5%. What’s more, a past provision that had been scrapped – giving the credit to a company that repurposed an existing drug as an orphan – was restored.

According to an October report by health research company QuintilesIMS and the National Organization for Rare Disorders (NORD), orphan drugs comprised 7.9 percent of the total U.S. drug sales in 2016. While that percentage doesn’t seem like a lot, it is when one considers that Quintiles estimates Americans will spend $580-610 billion on prescription medications by 2021 (the United States constitutes some 40 percent of the global pharmaceutical industry). Patients’ spending increased 5.8 percent between 2015 and 2016 alone.

At this moment, it’s still unclear what the future will hold for the Orphan Drug Tax Credit. Thus, it’s important to join the fight while we still can. Contact Congress to share your story, or contact a patient organization for your disease or disorder – over 200 have expressed their support for maintaining the credit. Each of us may just be one person, but together, we can influence our future.

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A lifelong Connecticut resident, Joanna Mechlinski is a former newspaper reporter who now works in education. She was diagnosed with lupus, fibromyalgia and polymyositis in her early twenties. In addition to helping spread rare and chronic illness awareness, Joanna is also passionate about animal advocacy, reading, writing, and road trips.

 Mary-Frances Garber is a licensed genetic counselor, providing supportive counseling for families in search of a diagnosis, a listening ear for those receiving a new diagnosis and decision-making counseling for individuals or couples facing choices regarding having another child . She also is available for bereavement counseling. Patients are seen in a private office setting in Needham, Massachusetts.
Listening, Reflecting, HealingSupportive Genetic Counseling 
Find more info here.
Meet our blog writers!
Jenna Anne
  I write to you as a wife and mother of 4 children. Three daughters and a medically complex son. I live in New England and have a love of fiber arts, music, and most importantly advocating for my children. My background is in Early Childhood Education and Music Education, I have no medical background aside from what I have had to learn on this medical journey. My writing is not statistic based, it’s not guidelines or resources but rather I bring a perspective from the human experience. Often in this world of medical complexity we focus specifically on the patient and the diagnosis and treatments, my writings offer the community a different perspective on how the day to day events are affected by medical interventions. The impact it has on siblings and family. The perseverance it takes to keep a wholesome family continuously adapting and thriving amidst all the challenges of medical complexity. My writings are often raw and unapologetic and speak to the human experience behind the policy, coding and diagnostics of modern medicine.  

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