program became effective, and how the Food and Drug Administration tracks such improvements. (4) The burdens associated with REMS, including burdens on patients, health care providers, generic drug manufacturers, brand drug manufacturers, pharmacies, and wholesale distributors. (5) In the case of a REMS program for a drug containing a controlled substance, the coordination between the Food and Drug Administration and the Drug Enforcement Administration. (6) The effect of additional risk mitigation strategies, including non-REMS restricted distribution systems, imposed by companies outside of what is required under the REMS program. (7) The standards and policies applied by the Food and Drug Administration to require, modify, add, or remove a REMS, and how those standards and policies have changed since the REMS program became effective. (8) The effect of REMS programs and additional risk mitigation strategies, including non-REMS restricted distribution systems, on generic entry into the marketplace. (9) The effect of REMS programs and additional risk mitigation strategies, including non-REMS restricted distribution systems, on pharmaceutical prices. (d) Report Not later than May 1, 2018, the Comptroller General shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate, the Special Committee on Aging of the Senate, and the Committee on Energy and Commerce of the House of Representatives, containing the results of the review described in this section.