Talk:Orphan Drug Act of 1983

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Orphan drugs? really?

Not sure that the following statement is correct. I will look for support on this statement. --Akrasia25 (talk) 10:59, 31 March 2019 (UTC)[reply]

The list of designated orphan drugs includes such blockbuster drugs as Abilify, Provigil, Vioxx, Botox, and Cialis^[1]

Abilify

NOT an orphan drug.--Akrasia25 (talk) 11:19, 31 March 2019 (UTC) It was approved by the FDA for schizophrenia on November 15, 2002 and the European Medicines Agency on 4 June 2004; for acute manic and mixed episodes associated with bipolar disorder on October 1, 2004; as an adjunct for major depressive disorder on November 20, 2007;[69] and to treat irritability in children with autism on 20 November 2009.[70] Likewise it was approved for use as a treatment for schizophrenia by the TGA of Australia in May 2003.[28][reply]

Provigil

Was an orphan drug but the reference is not that good. This one would be better.

^[2]

I will add it.--Akrasia25 (talk) 11:19, 31 March 2019 (UTC)[reply]

Vioxx

It was re-approved as an orphan drug but for a different and smaller indication. I think that it is a little misleading to say that this is a blockbuster BECAUSE it was an orphan drug. Certainly unlikely to be a blockbuster now given its troubles. This is acutally a good part of the law

In November 2017, Massachusetts-based Tremeau Pharmaceuticals announced its plan to return rofecoxib (TRM-201) to market as a treatment for hemophilic arthropathy (HA). Tremeau announced that the FDA had granted an orphan designation for TRM-201 (rofecoxib) for the treatment of HA, and that they had received FDA feedback on their development plan.[7] HA is a degenerative joint disease caused by recurrent intra-articular bleeding.--Akrasia25 (talk) 11:19, 31 March 2019 (UTC)[reply]

Botox

Same as Vioxx above. The specific orphan indication came after its popularity and companies get market protection for these indications.

Based on data from thousands of patients collected by 240 investigators, Allergan received FDA approval in 1989 to market Oculinum for clinical use in the United States to treat adult strabismus and blepharospasm, using the trademark Botox.[52] This was under the 1983 US Orphan Drug Act.[53]--Akrasia25 (talk) 11:19, 31 March 2019 (UTC)[reply]

Cialis

No. Always developed for ED and ED already had existing medications available so never would have been eligible for orphan status.--Akrasia25 (talk) 11:19, 31 March 2019 (UTC)[reply]

References

^ Wellman-Labadie, Olivier; Zhou, Youwen (1 May 2010). "The US Orphan Drug Act: Rare disease research stimulator or commercial opportunity?". Health Policy. 95 (2–3): 216–228. doi:10.1016/j.healthpol.2009.12.001. PMID 20036435.
^ Kesselheim AS, Myers JA, Solomon DH, Winkelmayer WC, Levin R, Avorn J (February 21, 2012). Alessi-Severini S (ed.). "The prevalence and cost of unapproved uses of top-selling orphan drugs". PLOS One. 7 (2): e31894. doi:10.1371/journal.pone.0031894. PMC 3283698. PMID 22363762.{{cite journal}}: CS1 maint: unflagged free DOI (link)

[1] Wellman-Labadie, Olivier; Zhou, Youwen (1 May 2010). "The US Orphan Drug Act: Rare disease research stimulator or commercial opportunity?". Health Policy. 95 (2–3): 216–228. doi:10.1016/j.healthpol.2009.12.001. PMID 20036435.

[2] Kesselheim AS, Myers JA, Solomon DH, Winkelmayer WC, Levin R, Avorn J (February 21, 2012). Alessi-Severini S (ed.). "The prevalence and cost of unapproved uses of top-selling orphan drugs". PLOS One. 7 (2): e31894. doi:10.1371/journal.pone.0031894. PMC 3283698. PMID 22363762.{{cite journal}}: CS1 maint: unflagged free DOI (link)

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