new-fda’s-section-804-drug-and-801d1b-biologic-importation-programs

New FDA’s Section 804 Drug and 801(d)(1)(B) Biologic Importation Programs

Live Webinar

  • 180 minutes

On December 23, 2019, the Food and Drug Administration (FDA) issued a proposed rule and draft guidance to implement and facilitate two pathways for the legal importation of certain drugs, which the FDA and the Department of Health and Human Services (HHS) first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 proposed rule, entitled “Importation of Prescription Drugs” (Pathway 1 Proposed Rule), implements “Pathway 1” of the action plan by proposing to authorize states, tribal or territorial governmental entities, wholesalers, or pharmacists to submit proposals outlining plans to import certain types of prescription drugs, from Canada, via time-limited Section 804 Importation Programs (SIPs).

The draft guidance, entitled ‘‘Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act’’ (Pathway 2 Draft Guidance), addresses “Pathway 2” of the Safe Importation Action Plan.  The Pathway 2 Draft Guidance describes procedures that drug manufacturers can follow to facilitate importation of their prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in a foreign country, and originally intended for sale in that foreign country.

Join this session by expert speaker Angela Bazigos, this presentation outlines the two proposed pathways through which HHS and FDA will allow for the importation of certain drugs originally intended for non-US markets. Notably, both pathways rely on parties other than the federal government—such as states, wholesalers, pharmacists, and manufacturers—to demonstrate that eligible drugs can be imported into the US safely and with the required cost savings.

Session Highlights:

  1. Section 804 – Pathway 1

  • Definition of Section 804 Importation Program (SIP)

  • Who would be permitted to sponsor a SIP

  • SIP authorization duration

  • Entities other than a sponsor and co-sponsors (if any) that would be involved in the SIP supply chain

  • Could a SIP Proposal include multiple foreign sellers and importers?

  • The statutory basis for FDA’s SIP proposed rule

  • Proposed criteria for a drug to qualify for importation from Canada under a SIP

  • Categories of drugs proposed to be excluded from importation under a SIP

  • SIP sponsors requirements

  • Information required for SIP Proposal

  • Testing requirements for SIP drugs

  • Eligibility criteria for SIP proposal

  • Importation process following FDA approval of SIP proposal

  • Entry submission options

  • Manufacturers:

  • Definition

  • Role in the SIP process

  • Manufacturer requirements

  • Foreign Sellers

  • Definition

  • Role in the SIP process

  • Foreign seller requirements

  • Importers

  • Definition

  • Role in the SIP process

  • Importer requirements

  • Labeling requirements for drugs under the SIP program

  • Application of FDA’s National Drug Code (NDC)

  • Cost savings for SIP drugs

  • Post importation requirements

  • Federal Health Care coverage and US Drug Price Reporting

  • Supply Chain Security

  • Pre-US supply chain information from the manufacturer to importer

  • Supply chain security requirements for foreign sellers

  • Track and trace information from the foreign seller to the importer

  • Purchasing product from a foreign seller if they are not an “authorized trading partner”

  • Information to be confirmed by the importer when receiving a product from a foreign seller

  • Track and trace information from the foreign seller, as required by the DSCSA

  • SNI portion of the product identifier: can the importer use the same serial number (i.e., the SSI) as the foreign seller

  • Where can importers ship eligible drugs to

  • What other DSCSA obligations would apply to importers

  • Information importer obtains from a manufacturer regarding a product’s pre-US supply chain

  • Section 801(d)(1)(B) – Pathway 2

  • Purpose of Pathway 2

  • Importing drugs under Pathway 2 vs Pathway 1

  • Countries acceptable for Pathway 2

  • Multi-Market Approved (MMA) products

  • Pathway 2 requirements

  • Labeling requirements for MMAs

  • Supplemental approval requirements for MMAs

  • Registration and listing requirements for MMAs

  • NDCs for Pathway 2

  • Supply Chain Security

  • Pricing requirements

  • National Drug Code (NDC) requirements

Why You Should Attend:

Some prescription drug products are priced much higher in the U.S. than abroad, raising questions about the adequacy of competition in U.S. markets for these drugs and whether new policy approaches, such as importation under section 804, might effectively limit prices in those markets and protect consumers from unreasonable price increases.

FDA has determined that a narrow implementation of section 804 through time-limited programs, overseen by states or certain other government entities (with possible co-sponsorship by a wholesaler or pharmacist), could enable importation to occur in a manner consistent with the certification criteria. This implementation could potentially provide relief to some American consumers from the burden of rising prescription drug prices.

Who Should Attend:

  • Pharmaceutical Companies

  • Biotech Companies

  • Drug and Biologic Importers

  • CROs and CMOS

  • Pharmacies

  • Hospitals

  • Healthcare insurance companies.




*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it at your convenience.

Angela Bazigos

Angela Bazigos

Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PricewaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA. Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry. Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Life Sciences industry.

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