S.Amdt. 751

SA 751. Mr. REED submitted an amendment intended to be proposed by him to the bill H.R. 2430, to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; which was ordered to lie on the table; as follows:

On page 97, strike line 20 and all that follows through line 9 on page 98 and insert the following:

“(k) Relation to Orphan Drugs.--

“(1) In general; exemption for orphan indications.--Unless the Secretary requires otherwise by regulation, this section does not apply to any drug for an indication for which orphan designation has been granted under section 526, except as provided in paragraph (2).

“(2) Applicability despite orphan designation of certain indications.--This section shall apply with respect to a drug or biological product for which an indication has been granted orphan designation under section 526--

“(A) if the pediatric cancer investigation described in subsection (a)(3) applies to the drug or biological product as described in subsection (a)(1)(B); or

“(B) if such orphan indication is limited to a pediatric subpopulation and such indication in the adult population does not qualify for orphan designation.

“(3) Effect of application.--Application of this section to drugs and biological products described in paragraph (2)(B) does not limit the applicability of section 526 to such drugs and biological products.”.