Shaking, rattling and Rolling Executives at FDA’s Orphan Development Dept re Generics gone sky hi!

Filenes basement is the best!!!! Check out this bright yellow dress for a happiness 'charge'!
Filenes basement is the best!!!! Check out this bright yellow dress for a happiness ‘charge’!




Dear Dr. Conte,

(Head of FDA’s Orphan Drug Development Department)


I’ve been trying to reach you and am getting tired of my envelopes being returned with a handwritten ‘not us’ on them. Obviously you are somewhere at the FDA as the head of ‘Orphan Drug Development Department.’ So I’m trying again and am not likely to go away.

Recently my Tardive Dyskinesia medicine went up from 2.65 a month to 300.00. Naturally it was dropped by my part D formulary, who gave me no advance notice. I found out at the pharmacy, out of medication for this horrible condition and out of the new cash price.

I’m pretty sure it was reclassified ‘Orphan.’ I watched your video on your role in Orphan Drug Development, and was puzzled you only mentioned ‘new’ drugs, which we know from Valeant and Turing’s antics, is not so. Older drugs are being given this status.

I’m a writer for the Huffington Post ‘Stronger Together,” “The Arizona Republic” “Bipolar Magazine” and other publications concerned with this issue.

I tried to find out if consumers could view a list of pending applications for ‘Orphan’ status and came across document “Title 21” section 316.50 which said that The FDA does not make that information public. If consumers were able to follow market conditions affecting their medication as well as how many manufacturers there are along with mergers and acquisitions, this would be closer to a level playing field for the consumers.

I’m not out to skewer you or make you look inept, I just want to know if you are considering making certain helpful info available to the public so we aren’t the last to know about factors that greatly influence our health. If we knew in advance, for example, we could apply for Drug Company Assistance!

Please call me at 954-922-4310 or have one of your staff do the same. I’d love to get a quote on record and Maryland is very far from Florida. But I would be willing to make the trip just to ask you a few questions.

I’m only trying to calm consumers who currently are rather alarmed at the FDA ‘Orphan Drug Development’s’ lack of transparency.




Allison Strong

Hollywood Florida


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