Responsibility for Off-label Claims in Social Media

April 1, 2020 - CA US


Overview: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.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.Areas Covered in the Session: Section 804 - Pathway 1Definition of Section 804 Importation Program (SIP)Who would be permitted to sponsor a SIPSIP authorization durationEntities other than a sponsor and co-sponsors (if any) that would be involved in the SIP supply chainCould a SIP Proposal include multiple foreign sellers and importers?Statutory basis for FDA's SIP proposed ruleProposed criteria for a drug to qualify for importation from Canada under a SIPCategories of drugs proposed to be excluded from importation under a SIPSIP sponsors requirementsInformation required for SIP ProposalTesting requirements for SIP drugsEligibility criteria for SIP proposalImportation process following FDA approval of SIP proposalEntry submission optionsManufacturers:DefinitionRole in the SIP processManufacturer requirementsForeign SellersDefinitionRole in the SIP processForeign seller requirementsImportersDefinitionRole in the SIP processImporter requirementsLabelling requirements for drugs under SIP programApplication of FDA's National Drug Code (NDC)Cost savings for SIP drugsPost importation requirementsederal Health Care coverage and US Drug Price ReportingSupply Chain SecurityPre-US supply chain information from manufacturer to importerSupply chain security requirements for foreign sellersTrack and trace information from the foreign seller to the importerPurchasing product from a foreign seller if they are not an "authorized trading partner"Information to be confirmed by importer when receiving product from a foreign sellerTrack and trace information from the foreign seller, as required by the DSCSASNI portion of the product identifier: can the importer use the same serial number (i.e., the SSI) as the foreign sellerWhere can importers ship eligible drugs toWhat other DSCSA obligations would apply to importersInformation importer obtains from a manufacturer regarding a product's pre-US supply chainSection 801(d)(1)(B) - Pathway 2Purpose of Pathway 2Importing drugs under Pathway 2 vs Pathway 1Countries acceptable for Pathway 2Multi-Market Approved (MMA) productsPathway 2 requirementsLabelling requirements for MMAsSupplemental approval requirements for MMAsRegistration and listing requirements for MMAsNDCs for Pathway 2Supply Chain SecurityPricing requirementsNational Drug Code (NDC) requirementsWho Will Benefit:Regulatory VPQuality VPsIT VPsRegulatorsEngineeringManufacturingResearchLegalPharmacyDoctorsNursesHospital administratorsRegulatory Affairs professionals: Quality Managers, Quality EngineersSmall business Owners, Medical Device ConsultantsSpeaker ProfileAngela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training for Society of Quality Assurance.Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences.Event link: InfoNetzealous LLC, DBA -Compliance4allEmail: support@compliance4All.comPhone: +1-800-447-9407Website:

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