Limitations on Exclusive Approval or Licensure of Orphan Drugs
Section 6605 · Sec. 6605 ·
What this chapter is about
This part narrows a seven year exclusive period for drugs for rare diseases. It now attaches to the approved use, not to the whole disease. It applies to every such drug, whenever it was designated or approved.
The document says “is amended”Who acts: CongressHow: statuteSec. 6605 in the PDF
What the document says
“in subsection (a), in the matter following paragraph (2), by striking ``same disease or condition'' and inserting ``same approved use or indication within such rare disease or condition'';”
Subsection (a) of section 6605 amends section 527 of the Federal Food, Drug, and Cosmetic Act in three places, replacing references to the same disease or condition with references to the same approved use or indication. It adds a new subsection (f) defining approved use or indication as the use approved under section 505 of that Act, or licensed under section 351 of the Public Health Service Act, for a drug designated for a rare disease or condition.
What the document actually says
“in subsection (a), in the matter following paragraph (2), by striking ``same disease or condition'' and inserting ``same approved use or indication within such rare disease or condition'';”
That sentence, in plain words
Cross out four words about a disease. Write in words about the approved use within that disease.
What this is about
An orphan drug treats a rare disease. Its maker gets seven years with no rival. Tying that to one use, not the whole disease, leaves room for others.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “shall apply”Who acts: Secretary of Health and Human ServicesHow: statuteSec. 6605 in the PDF
What the document says
“The amendments made by subsection (a) shall apply with respect to any drug designated under section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), regardless of the date on which the drug was so designated, and regardless of the date on which the drug was approved”
Subsection (b) of section 6605 makes the amendments apply to any drug designated under section 526 of the Federal Food, Drug, and Cosmetic Act, whatever the date of designation, and whatever the date of approval under section 505 of that Act or licensure under section 351 of the Public Health Service Act.
What the document actually says
“The amendments made by subsection (a) shall apply with respect to any drug designated under section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), regardless of the date on which the drug was so designated, and regardless of the date on which the drug was approved”
That sentence, in plain words
The changes cover any drug marked for a rare disease. When it was marked does not matter. When it was approved does not matter.
What this is about
A change that covered only new drugs would take years to bite. This one reaches drugs already on the market.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The two things the section does: replace the disease or condition wording with approved use or indication in three places and define that term, and apply the amendments regardless of designation or approval date.
The three parallel phrase changes listed one by one.
The section amends section 527 of the Federal Food, Drug, and Cosmetic Act, which is not indexed here, so how the exclusivity period otherwise works is not recorded on this site.
