committee of the provisionally approved drug or for approval of the provisionally approved drug under section 505 of this Act or section 351 of the Public Health Service Act. (2) Waiver of adequate and well-controlled study requirements (A) In general In considering whether to recommend a drug that was provisionally approved under this section for approval under section 505, the Director of the Center for Drug Evaluation and Research shall consider the option to waive requirements for adequate and well-controlled studies in accordance with the process described in section 314.126(c) of title 21, Code of Federal Regulations (or successor regulations). (B) Biological products In considering whether to recommend a biological product that was provisionally approved under this section for licensure under section 351 of the Public Health Service Act, the Director of the Center for Biologics Evaluation and Research may, and shall consider the option to, waive requirements, as applicable, for adequate and well-controlled studies for such biological product in accordance with the process described in section 314.126(c) of title 21, Code of Federal Regulations (or successor regulations). . (b) Conforming amendment Section 505(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(a) ) is amended by inserting , or there is in effect a provisional approval under section 524C with respect to such drug before the period. (c) Reimbursement (1) Private health insurers Section 2719A of the Public Health Service Act ( 42 U.S.C. 300gg–19a ) is amended by adding at the end the following: (f) Treatment of certain drugs A group health plan or health insurance issuer of group or individual health insurance coverage shall not deny coverage of any drug provisionally approved under section 524C of the Federal Food, Drug, and Cosmetic Act on the basis of such drug being experimental. In determining coverage under the applicable plan or coverage, a group health plan or health insurance issuer shall treat a drug provisionally