More on generic sticker shock on generics reclassified ‘Orphan’

fighting mad

Orphan drug act of 83 was written to subsidize development of new drugs but it’s being used for old generics we depend on to be affordable and available. I wrote the following to the Chief of FDA office of Orphan Drug Development, Dr. Tim Cote. If you wish to communicate with him on this matter go ahead. I simply want to know if pending applications are of public record. They should be as they would give us a ‘heads up’ in advance of a dramatic price hike on meds we expect to be affordable and accessible.



Dear Dr. Cote,


This letter and self addressed stamped envelope asks some questions about the use of the Orphan Drug Act for generic drugs, particularly psychiatric drugs, since I’m a psych patient and so are my readers at Bipolar Hope and Huff Post ‘To Your Health’ and ‘Stronger Together.’

As far as I can tell, generic inflation drivers are mergers, acquisitions and spinoffs resulting in a single manufacturer who then has unlimited pricing power. More disturbing is the use of ‘Orphan Drug Act of 1983’ to reprice generics with multiple applications and the fact that your video online explaining the ins and outs of ‘Orphaning’ new drugs for rare diseases doesn’t mention the fact that generics are getting reclassified.

I want to know asap whether pending ‘Orphan’ applications for generics are a matter of public record so I can help my readers examine their lists of time honored treatments, examine current market conditions and possible future price hikes so they can have a few backup plans and apply for prescription assistance.

If it’s not public record, why not? Whether a drug is psychiatric for a life threatening parasitic infection or virus, we need to be able to anticipate and budget for our health expenses so we can maintain our health. Please scan the particulars of my case in point and please return the self addressed, stamped post card and let me know if I can contact you for comments or speak with one of your representatives to answer my questions. I was unable to find an email for you so I figured I’d try snail mail.


I realize that the media feeding frenzy and senate oversight committees are remarkably one sided. I don’t aim to take aim at the FDA or people like Martin Shkreli. I just want to help mental health consumers become aware of market conditions that may dramatically affect the prices of their drugs.

I’ve been researching generic inflation for some time and have read at least fifty articles on the subject. I was shocked to hear that ‘Orphan’ status is being used to reprice decades old generics since I’m on quite a few and a few months ago, one of my Tardive Dyskinesia/Psych meds was reclassified ‘Orphan,’ and the price went up to 300.00 a month. Dropped from Part D Forumulary, I am responsible for the entire 300 and can’t pay for it and am shaking like a leaf. For one thing, even though this old benzo is used for Tardive, it’s also used for anxiety so I don’t see how it could be reclassified.


I’m on straight Medicare (No Medicare ‘Disadvantage’ plan HMO for me, thank you. Too few drugs and doctors are accessible on those). My Part D prescription drug plan, Silverscript (Owned by CVS), (can you spell conflict of interest?), dropped my medication from formulary and I can’t afford it. My income is such that I’m not below poverty line and can’t get assistance from the drug company, Ricordati Rare Diseases. I’m shaking like a leaf.

Tardive Dyskinesia is considered ‘orphan’ inaccurately estimated as affecting 200k United States citizens or less. With the dramatic upswing in prescribing of atypical antipsychotics off label for a variety of applications, it won’t be ‘orphan’ much longer, I fear.

It’s a Parkinson’s like neurological movement disorder side effect from antipsychotics, both traditional and atypical. Nami now says Tardive will hit 30-50% of patients taking atypical antipsychotics or traditional antipsychotics like Haldol who take them over a ten year period.

Tardive Dyskinesia is disfiguring, disturbing, and results in stigma and discrimination. Docs don’t want you as a patient for fear of being embroiled into a future lawsuit. I need my tardive meds, receive prescription assistance for one of them but the other one went orphan and caught me off guard because I didn’t see it coming.

I have other side effects from 25 years of psych drugs and medical expenses so high you can’t believe it. I spend over a thousand a month on doctors and drug copays and go through donut hole each year and have to cover that out of pocket expense.

I’m trying to do something positive by writing a nationally published story on how consumers can ‘spot and sidestep oncoming stickershock’ so they won’t get surprised at the cash register when they are all out of meds; expecting an easy, immediate and affordable refill.


You said the protective ‘Orphan’ status was only used for new drugs in your video but that’s not the truth. Why are you still lying to the American Public? This makes you no less culpable than former Turing CEO Martin Shkreli, the guy they’re calling the Gordon Gecko or ‘Bad Boy’ of Big Pharma.

How does that strike ‘ya?

Allison Strong

Nationally Published Mental Health Writer.

Oh, and by the way, if you think you can ignore me, I’m not going away. I’m not fond of the word ‘no,’ and when it’s appropriate I go after what I want, even if I have to travel to the ends of the earth.