1. Short title This Act may be cited as the Helping Experts Accelerate Rare Treatments Act of 2020 . 2. Improving the treatment of rare diseases and conditions (a) Annual report on orphan drug program Subchapter B of chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360aa et seq.) is amended by adding at the end the following new section: 529B. Annual report on orphan drug program (a) In general Not later than 1 year after the date of enactment of the Helping Experts Accelerate Rare Treatments Act of 2020 , and not less than annually thereafter, the Secretary shall submit to the Congress a report summarizing the activities of the Food and Drug Administration for designating drugs under section 526 for a rare disease or condition and approving such drugs under section 505 of this Act or licensing such drugs under section 351 of the Public Health Service Act, including— (1) the number of applications for such drugs under sections 505 of this Act and section 351 of the Public Health Service Act received by the Food and Drug Administration, the number of such applications considered by each Food and Drug Administration division, and the number of such applications pending and approved; (2) the number of applications described in paragraph (1) disaggregated by— (A) the disease or condition to be addressed; and (B) the target subpopulations identified in such applications; (3) the prevalence in the United States of each disease or condition addressed by an application described in paragraph (1); (4) integration of Food and Drug Administration staff with expertise in rare diseases and conditions in each review of an application described in paragraph (1); (5) identification of all external experts with expertise in rare diseases and conditions who are consulted in connection with, or who otherwise participate in, each review of an application described in paragraph (1)