Guidance For Industry - Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, Under Section 801(d)(1)(B) Of The Federal Food, Drug, and Cosmetic Act
John is serving in his fourth career as Senior Consultant with Ceutical Labs, Inc. Flower Mound, TX. John retired from the FDA’s Office of Cosmetics and Colors in June 2019 where he served as an SME in the areas of personal care product microbiology and manufacturing (GMP’s). Prior to FDA John served in a global capacity with Estee Lauder Companies responsible for regulatory compliance in all manufacturing facilities. In 1982 John took over the helm of Food and Drug Standards Manager for the State of Wyoming Department of Agriculture, where he became an internationally recognized leader in the adaptation of HACCP principles to regulatory programs. John was promoted to Deputy Commissioner of Agriculture prior to leaving for Este Lauder.
John Grew up on a farm in Ohio where he learned a great deal about self-reliance, resilience, and creativity. Leaving the farm to start his journey, John graduated from The Ohio State University and the University of Wyoming. The skills that John learned in those early years bring him to you today. If you have a chance, ask John about his experience as a shepherd in Wyoming’s Big Horn Mountains. John is also a musician and vocalist, something he has enjoyed since performing professionally at age 16.
On December 23, 2019, the Food and Drug Administration (FDA) issued a proposed rule and draft guidance to facilitate the legal importation of certain drugs, which the FDA and the Department of Health and Human Services (HHS) first described in a July 31, 2019, Safe Importation Action Plan. The Safe Importation Action Plan (SIP) introduces two possible pathways for such importation.
FDA has issued the GUI – Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act with the intention of outlining one of these potential pathways. This regulatory pathway allows for the manufacturers to obtain an NDC for an FDA-approved drug that was originally intended to be marketed in a foreign country and is also authorized for sale in that foreign country. By following the procedures described in the GUI – Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act, manufacturers could obtain an NDC for an MMA product, which would provide an additional avenue through which drugs could be sold at a lower cost in the U.S. market.
Under this pathway, a manufacturer could import such a drug if, consistent with section 801(d)(1)(B) of the FD&C Act, the drug is manufactured outside the United States and the manufacturer has authorized the drug to be marketed in the United States and has caused the drug to be labeled to be marketed in the United States. In addition to other requirements, under section 801(a) of the FD&C Act, to be lawfully imported into the United States, drugs must not be in violation of section 505 of the FD&C Act (21 U.S.C. 355) or be adulterated in violation of section 501 of the FD&C Act (21 U.S.C. 351) or misbranded in violation of section 502 of the FD&C Act (21 U.S.C. 352).
This GUI also describes the recommended procedures for submitting certain documentation to demonstrate that the drug offered for import, although originally intended for marketing in a foreign country, is, in fact, an FDA-approved drug and meets the required specifications in the approved new drug application (NDA) or BLA, and thus may be eligible for importation under section 801(a) and (d) of the FD&C Act. In addition to detailing the processes for registration and listing and obtaining an NDC for such drugs, Guidance for Industry - Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act also describes recommended labeling changes for MMA products.
An MMA product offered for import that meets the DSCSA definition of a “product,” like all DSCSA products, is subject to all applicable requirements of section 582 of the FD&C Act. For MMA products, these requirements are intended to help ensure that appropriate product safety and supply chain integrity safeguards are in place to reduce the possibility of counterfeit, substandard, or other unapproved products entering the closed U.S. supply chain.
- What is an MMA drug product?
- What is an MMA biologic product?
- What is an MMA combination product?
- The process for submitting a supplement to an approved FDA application for an MMA product
- The recommended labeling for an MMA product
- The process for registration and listing and for obtaining an NDC for the MMA product
- The requirements of section 582 of the FD&C Act (21 U.S.C. 360eee-1) as added by the Drug Supply Chain Security Act (DSCSA)
- Recommendations related to procedures for importation of the MMA product
- Other FDA requirements applicable to MMA products
Course Level - Basic/Fundamental
Who Should Attend
Quality Assurance, External Manufacturing/Outsourcing, Regulatory Affairs, Compliance, Purchasing.
Why Should You Attend
- This training will support the development of a comprehensive understanding of the Safe Importation Action Plan (SIP) requirements for Multi-Market Approved (MMA) drug products
- This training will support the preparation for and management of the legal importation of certain drugs originally intended and approved for foreign markets
- In this training, we will detail procedures that will enable manufacturers to import drugs by obtaining an additional NDC for the MMA product
- Providing legal pathways for the importation of these drugs which have already been approved for foreign markets could allow greater pricing flexibility
- This training will help ensure manufacturers are aware of MMA procedures that may provide access to lower-cost drugs in the United States
- The additional NDC also will support pharmacovigilance, accurate billing, and reimbursement, and facilitate the clearance of the MMA products through customs
- Further opening of the domestic drug market to foreign competitors and MMA products may result in significant savings for the American consumer
- This guidance, by outlining the procedure for the importation of MMA products, may establish a way for manufacturers to offer lower-cost versions of their drugs where they otherwise could not readily do so because they are locked into contracts with other parties in the supply chain. Certain manufacturers have recently begun to market lower-cost versions of their drugs under different NDCs, as an alternative to the existing higher-priced version
- Drug approvals for multiple markets being issued by the certifying body and replacing multiple market approval processes for single drug products may reduce research and development costs. This reduction may result in an increased ROI for the manufacturer/owner
The U.S. spends more on pharmaceutical drugs than residents of any other developed country. We pay higher prices for the exact same drugs, even when they are produced and shipped from the exact same facilities. Some drug manufacturers have indicated an interest in offering certain of their drugs at lower costs and that obtaining additional NDCs for these drugs may help them to address certain challenges in the private market. The importation of such drugs into the U.S. may also result in significant savings for the American consumer as well.