Replies to post #122739 on Biotech Values

[iwfal]

Orphan drug exclusivity --- applies only to a "same" drug in the "same" indication. See below cites from FDA Legal experts, Nature and the FDA regulations themselves.

Obviously "same" is subjective to some degree and will differ depending upon need ("same" for generic approval purposes is, perforce, a science driven and very tight sameness, while "same" for purposes of encouraging people to invest to get orphan protection could be more loosely tuned to incentivize people to invest.)

FDA Law Blog:

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2009/05/stereoisomer-orphan-drug-sameness-another-interesting-counterpoint-to-fdas-first-permitted-commercia.html

Once FDA approves a marketing application for a designated drug, the Agency may not approve another company’s version of the “same drug” for the same disease or condition for seven years, unless the subsequent drug is different from the approved orphan drug, or because the sponsor of the first approved product either cannot assure the availability of sufficient quantities of the drug or consents to the approval of other applications.

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Nature:

http://www.nature.com/nbt/journal/v21/n1/full/nbt0103-6b.html

once the FDA approves one orphan drug, it is barred from approving the same chemical entity for the same disorder from a different company unless that second drug is shown to be "clinically superior.

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And, of course, the FDA regulation itself:

http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesignation/ucm124562.htm

5) Where the sponsor of a drug that is otherwise the same drug as an already approved orphan drug seeks orphan drug designation for the subsequent drug for the same rare disease or condition, an explanation of why the proposed variation may be clinically superior to the first drug. - (Note that nowhere else in the reg is superiority required - i.e. it is not, per se, required for a different drug.)


PS I didn't include the actual law because it is very difficult to parse for non-lawyers. For reasons I do not understand US legal culture uses very non-standard language structure AND completely avoids ever describing the other side of legal boundaries.