About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline
LOG IN
LOG IN

B-332649 1 (2020-11-06)

handle is hein.gao/gaobaebzr0001 and id is 1 raw text is: c tAO U.S. GOVERNMENT ACCOUNTABILITY OFFICE 441 G St. N.W. Washington, DC 20548 B-332649 November 6, 2020 The Honorable Lamar Alexander Chairman The Honorable Patty Murray Ranking Member Committee on Health, Education, Labor, and Pensions United States Senate The Honorable Frank Pallone, Jr. Chairman The Honorable Greg Walden Ranking Member Committee on Energy and Commerce House of Representatives Subject: Department of Health and Human Services, Food and Drug Administration: Importation of Prescription Drugs Pursuant to section 801(a)(2)(A) of title 5, United States Code, this is our report on a major rule promulgated by the Department of Health and Human Services, Food and Drug Administration (FDA) entitled Importation of Prescription Drugs (RIN: 0910-A145). We received the rule on October 22, 2020. It was published in the Federal Register as a final rule on October 1, 2020. 85 Fed. Reg. 62094. The effective date of the final rule is November 30, 2020. The final rule implements section 804(b) through (h) of the Federal Food, Drug, and Cosmetic Act to allow importation of certain prescription drugs from Canada. Pub. L. No. 75-717, 52 Stat. 1040 (June 25, 1938). Under the rule, according to FDA, states and Indian Tribes, and, in certain future circumstances, pharmacists and wholesalers, may submit importation program proposals to FDA for review and authorization. FDA states that the rule contains all requirements necessary for a sponsor to demonstrate that their importation program will pose no additional risk to the public's health and safety, and requires that the sponsor explain how they will ensure their program will result in a significant reduction in the cost of covered products to the American consumer. The Congressional Review Act (CRA) requires a 60-day delay in the effective date of a major rule from the date of publication in the Federal Register or receipt of the rule by Congress, whichever is later. 5 U.S.C. 801(a)(3)(A). The final rule was published in the Federal Register on October 1, 2020. 85 Fed. Reg. 62094. The Congressional Record does not indicate that either House of Congress received the rule. According to FDA, the rule was delivered to each House of Congress on October 23, 2020. Email from Regulations, Policy & Management Staff, FDA, to Senior Attorney, GAO (Nov. 5, 2020). The rule has an effective date of November 30, 2020. Therefore, the final rule does not have the required 60-day delay in effective date.

What Is HeinOnline?

HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.



Contact us for annual subscription options:

Contact Us

Already a HeinOnline Subscriber?

Log In

profiles profiles most