Drug Product Market Supply Compliance and Challenges. 6 th November, 2017 Lara Hansen, Associate Director, Sandoz Regulatory Affairs

Transcription

1 Drug Product Market Supply Compliance and Challenges 6 th November, 2017 Lara Hansen, Associate Director, Sandoz Regulatory Affairs

2 Disclaimer This presentation contains a summary of the opinion and perspective from industry representatives on the topic of Drug Product Market Supply Compliance and Challenges This presentation does not necessarily represent the opinion of the presenter nor its employers.

3 Industry Goals

4 Drug Product Market Supply - Balance Patients Compliance Customers

5 Drug Product Market Supply - Patients Consistent/Reliable Supply High Quality Product Access to medically needed drug products Life supporting; life sustaining ; or intended for use in the prevention or treatment of a debilitating disease or condition * * DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration, 21 CFR Parts 20, 310, 314, and 600 [Docket No. FDA-2011-N-0898]

6 Drug Product Market Supply - Compliance Meet the FDA Final Rule - Permanent Discontinuance or Interruption in Manufacturing of Certain Drugs or Biological Products under FDASIA* On July 8, 2015 FDA published a Final Rule implementing drug shortage provisions enacted under sections 506C and 506E of Food and Drug Administration Safety and Innovation Act (FDASIA) The rule requires notification of FDA of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful or significant disruption of the product in the United States Electronic notification 6 months in advance or as soon as practicable, but in no case less than 5 business days after the permanent discontinuance or interruption Provide transparency with the FDA Office Drug Shortage Collaborate to eliminate any potential market impact or meaningful disruption * DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration, 21 CFR Parts 20, 310, 314, and 600 [Docket No. FDA-2011-N-0898]

7 Drug Product Market Supply - Customers Internal company cross function collaboration Marketing/Sales/Supply Chain/Regulatory/Compliance Meeting supply agreement requirements - Providing agreed communication to customers - Maintaining supply as agreed to prevent Failure to Supply Penalty

8 Drug Product Market Supply - Customers Customer Landscape Industry Customers are typically Retail and Wholesalers Top 3 customers control ~90% GX market Failure to Supply Penalty (FTS) for Industry: Notification required to Wholesaler/Retail customers within financial terms. Retail customers: they cannot let customer walk out due to out of stock and lose high margin sale and cause customer retention issue they can access alternatives from wholesalers FTS is to pay for replacement cost at a much higher price than contract Wholesaler customers: they cannot access product from wholesalers (as they are competitors) FTS often times is penalty based on industry service

9 Reporting Process

10 Drug Product Market Supply - Process Industry FDA Customers

11 Drug Product Market Supply FDA Guidance for Reporting* A business decision to permanently discontinue manufacture; A delay in acquiring APIs or inactive ingredients that is likely to lead to a meaningful disruption in the applicant s supply while alternative suppliers are located; Equipment failure or contamination affecting the quality of the covered drug or biological product that necessitates an interruption in manufacturing while the issue is addressed, and that is likely to lead to a meaningful disruption in the applicant s supply of the product; Manufacturing shutdown for maintenance or other routine matters, if the shutdown extends for longer than anticipated, or otherwise is likely to lead to a meaningful disruption in the applicant s own supply ; A merger of firms of transfer of an application for a covered drug or biological product to a new form, of the merger or transfer is likely to lead to a meaningful disruption in the applicant s supply An interruption in manufacturing (e.g., contamination of a manufacturing line) that in the applicant s view may not meaningfully disrupt the market-wide supply of the covered drug or biological product (for example, because the applicant holds only a small share of the market for the product), but that the applicant determines is likely to lead to a meaningful disruption in its own supply. * DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration, 21 CFR Parts 20, 310, 314, and 600 [Docket No. FDA-2011-N-0898]

12 Drug Product Market Supply - Causes Discontinuation Generic drug price erosion and/or increasing costs No Customers under contract Change in Company Strategy/Portfolio Interruption in Supply Quality Event (Recall, Warning Letter, Import Alert) Discontinuation in API supply Unplanned Manufacturing Variations Submission category change (CBE-30 to PAS) Man-made or natural disaster

13 Drug Product Market Supply Industry Process Legal Sales/ Marketing Compliance Supply Chain Quality Regulatory

14 Drug Product Market Supply FDA Notification Industry Notifies FDA of Market Impact /Phone Drug Shortage Reporting Website FDA confirmation of information FDA Notifies Industry of Shortage/Discontinuation Posts on website s Industry for specific requests Market Notifies Industry and/or FDA Patients, Pharmacist, Physicians contact Industry Customer Service Patients, Pharmacist, Physicians contact Drug Shortage

15 Potential Industry Challenges: Drug Shortage Reporting

16 Drug Product Market Supply Potential #1 Top 3 customers control ~90% Gx market, commanding strong negotiating power Continuous ANDA approval at an accelerated pace increases competition, further eroding manufacturers position Deteriorating profits eventually force manufacturers to exit certain products and even close sites Most commitment on customer notification is 3 months. Building 6-month inventory upon customer notification will cause write-off even if customers stay the full 3 months instead of moving sooner to other suppliers Even if there is market impact this extra 3 months of inventory is not readily available for other customers

17 Drug Product Market Supply Potential #2 DMF Holder had supply issues Product Interruption reported to FDA Drug Shortage Off the market for many months Lost Customers to others that did not have supply issues Permanently Discontinued supply Less than 6 months notice of discontinuation

18 Drug Product Market Supply Potential #3 Manufacturing Site Identifies a needed variation Regulatory Team Assesses a CBE-30 with supportive batch and files Site expects implementation on Day 31 Batch ready for distribution FDA Assesses the change as PAS, requiring a 5-6 month delay in approval

19 Drug Product Market Supply Potential #4 API Manufacturing Update DMF Amendment Submitted and Variation implemented DMF update requires a CBE-30 No API from previous process available Interruption in drug product supply Less than 6 months notice of discontinuation

20 Lara Hansen, Associate Director, Regulatory Affairs Sandoz Inc Midway Blvd Broomfield, CO USA