Advisory Market Update

This the Advisory Market Update for September 2020 from IntegriChain. We want to keep you up-to-date with relevant, timely industry insights and regulatory updates that may impact your business. If you have questions on any of the content found in this or other newsletters, reach out to your IntegriChain Advisory Lead or and we would be happy to talk you through it.

Did You Know?

340B – AstraZeneca (AZ) Pushes Back Against Contract Pharmacies

AZ is jumping on the bandwagon in a rally against 340B covered entities (“CE”) that partner with multiple contract pharmacies. In our August market update, we noted that Eli Lilly had stopped providing 340B pricing to covered entities that provided their product, Cialis, to multiple contract pharmacies.  AZ is now following suit, by refusing to offer 340B to covered entities across all their products where the CE uses multiple contract pharmacies. The refusal of 340B pricing to CEs with multiple contract pharmacies will go into effect on 10/1.

You can read more about their recent decision here.


FDA Imposes additional drug reporting for NDA and ANDA holders

The FDA Reauthorization Act of 2017 enacted on August 18, 2017, recently added section 506I to the Federal Food, Drug, and Cosmetic Act. Section 506I imposes additional reporting requirements on new drug application (NDA) and abbreviated new drug application (ANDA) holders regarding the marketing status of approved products, including:

  • Notification of withdrawal from sale, which requires NDA and ANDA holders to provide written notification to FDA 180 days prior to withdrawing an approved drug from sale
  • Notification of drug not available for sale, which requires NDA and ANDA holders to provide written notification to FDA within 180 days of the date of approval of a drug if that drug will not be available for sale within 180 days of the date of approval

You can access the complete guidance and required formats here


CMS Issues Warning Termination Notices 

CMS is currently conducting product data reviews, comparing the FDA NSDE Structured Product Labeling [SPL] drug report to the Medicaid Drug Listing database. Several manufacturers have received notification the FDA product data and the CMS Medicaid Drug Listing data do not reconcile.  Advising the manufacturer they have 60 days to remediate/correct the product data or be subject to MDRP termination. 

As part of the Per CMS manufacturer program release notes, [Mfg. Rel.# 084] they “strongly encourage” manufacturers to review the FDA SPL drug report and ensure CMS Medicaid Drug Listing data is reconciled.  As an example, products listed in the FDA database are not listed in the Medicaid Drug Listing database; market dates differ; products terminated in the FDA SPL drug report are listed as active in the Medicaid Drug Listing database. 

You can access the CMS Memo and FDA SPL drug report here.

About the Author

Rupal Patel

Rupal Patel

Executive Director, Operational Consulting

Rupal Patel is Executive Director in IntegriChain’s Operational Consulting practice, responsible for overseeing and leading the Government Pricing Advisory team. She is a recognized trusted advisor to Life Sciences manufacturers with an extensive record of success delivering strategic solutions that improve organizational accuracy, efficiency, and compliance. Currently she oversees more than 150 small- to mid-sized manufacturers and has extensive experience in leading pre-commercial launch projects for both Government Pricing and State Price Transparency.