Critical Hospital IV Solution Shortages: FDA and ASPR Actions · Branch Chief, Critical...
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6/21/2018 1 Critical Hospital IV Solution Shortages: FDA and ASPR Actions Dec. 5, 2017 Agenda • Background and AHA Advocacy: Roslyne Schulman, Director, Policy • FDA Update on Drug Shortages: CAPT Valerie Jensen R.Ph., Associate Director, Drug Shortage Staff, FDA, Center for Drug Evaluation and Research • ASPR Healthcare and Public Health Sector Supply Chain Preparedness and Response: Laura Kwinn Wolf, Ph.D., Branch Chief, Critical Infrastructure Protection, ASPR, Office of Emergency Management
Transcript of Critical Hospital IV Solution Shortages: FDA and ASPR Actions · Branch Chief, Critical...
6/21/2018
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Critical Hospital IV Solution Shortages: FDA
and ASPR Actions
Dec. 5, 2017
Agenda
• Background and AHA Advocacy: Roslyne Schulman, Director, Policy
• FDA Update on Drug Shortages: CAPT Valerie Jensen R.Ph., Associate Director, Drug Shortage Staff, FDA, Center for Drug Evaluation and Research
• ASPR Healthcare and Public Health Sector Supply Chain Preparedness and Response: Laura Kwinn Wolf, Ph.D., Branch Chief, Critical Infrastructure Protection, ASPR, Office of Emergency Management
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Shortages of Small-volume IV Solutions
• Existing shortages of small-volume IV solutions
o Made worse due to impact of Hurricane Maria on Puerto Rico’s drug manufacturing plants
• These shortages are quickly becoming a crisis and looming threat to the public’s health
• The AHA is urging FDA and Congress to take immediate action to expedite the resolution of these shortages
AHA urges FDA and Congress to Act to Address Critical Drug Shortages
FDA Updates on Drug Shortages
CAPT Valerie Jensen RPh.
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FDA UPDATES ON DRUG SHORTAGES
CAPT Val Jensen RPh.
Associate Director
FDA/CDER/Drug Shortage Staff (DSS)
December 5, 2017
• FDA’s Drug Shortage Process and Effects of Notification• Current shortages – hurricane update• New initiatives at FDA and future of shortages – what’s still needed
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FDA Updates on Drug Shortages
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Drug Shortage Staff: The program office that is designated by FDA to oversee and facilitate the resolution of all drug shortage situations
DSS serves to support FDA’s mission of ensuring that safe and effective drugs are available to patients
• Facilitate temporary and long-term strategies to address shortages
• Coordinate for timely and comprehensive risk/benefit decisions
• Distribute information (web posting, professional organizations)
Often working across suppliers, facilities, and issues – multiple moving parts, urgency
Maintain availability while minimizing risk to patients
FDA Drug Shortage Staff (DSS)
At the time of any change in manufacturing that may lead to a reduction in supply of a product*, e.g.:
• Plans for upgrade or remediation• Manufacturing issues at CMO• API batch failures• Media fill failure
FDA asking manufacturers to notify FDA ahead, not as, or after, they are unable to fill orders or unable to meet expected demand
*Note, product refers to a specific strength, dosage form, and route of administration
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Best Practices
“We have placed the following product(s) on hold pending an investigation. Due to the investigation being in progress and the completion date being not estimated at this time, we wanted to inform Drug Shortage of this potential for a supply interruption.”
Manufacturers Report on Potential Impact to Supply
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Manufacturers are required to notify the FDA of “a change in production that is reasonably likely to lead to a reduction in the supply” of a covered drug in the United States
• “At least 6 months in advance of…but in no case later than 5 business days after the…interruption in manufacturing occurs”
• Not limited to medically necessary products
• Regardless of market share, or number of companies marketing, or wholesaler volumes
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Requirements to Industry For Early NotificationsUnder Section 506C of the FD&C Act (2012)
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If there is a critical shortage concern, then DSS can:
• Request expedited FDA review and inspection of all pending applications to prevent shortage or to assist with demand, as well as facilitate pre-submission advice
• Contact all manufacturers for status of supply, extent and timing for manufacturing capacity or constraints
• Inquire on allocation plans or emergency reserves• Assist with import requests for ongoing marketed supply• Coordinate with manufacturers in their efforts to address
root cause or to minimize shutdowns or delays• Prioritize drugs of critical patient need• Coordinate on risk mitigation measures• Facilitate consideration for regulatory discretion
FDA Drug Shortage Staff – Toolbox
Manufacturers coordinate with DSS in order to prevent, mitigate, and resolve potential and existing drug shortages
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• Ongoing dialogue/work with industry –high numbers of prevented shortages continue (115 in 2016)
• New shortages have decreased, however there have been ongoing shortages that have been difficult to resolve.
Impact of Early Notifications to the FDA
0
50
100
150
200
250
300
Sterile Injectables
All Forms
Total New US Drug Shortages Per Year
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FDA Drug Shortage Staff – Key Communications
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• Hurricane Maria affected multiple manufacturers in Puerto Rico –FDA working closely with the firms to mitigate shortage impact
• Baxter has experienced shortages related to Hurricane Maria and currently IV fluids (dextrose and saline) in multiple sized bags as well as amino acids are critical as well as several others - imports being initiated from 6 different Baxter sites, and FDA expediting review of applications for new suppliers, and working with other manufacturers to help resolve these shortages.
Hurricane Impact
Connecting Pharmaceutical Knowledge ispe.org
-Began in 2014 – increased demand and tight capacity
-FDA expedited review of 2 new manufacturers Fresenius Kabi and Laboratorios Grifols
-B. Braun reported slowing of production in fall 2017 from their approved facility. Currently importing from a German facility.
-Baxter PR site impacted by Hurricane Maria – now back in production and imports continuing from 4 Baxter sites
-FDA will continue to monitor supplies and continue imports as long as they are needed to meet patient needs.
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IV Fluids Shortage
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Opportunities and Challenges to Assist with Shortages
What we CAN require:• Notification by manufacturers (FDASIA)
• Supply disruptions• Delays• Discontinuations
• Notification of manufacturing changes
What we CANNOT require:• A company to make a drug• A company to make more of
a drug• How much and to whom the
drug is distributed
FDA will work closely with manufacturers to address problems• We can advise, assist, and expedite, but the manufacturer must fix the problem
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• Establish the FDA Drug Shortage Assistance Award
• Drug Competition and Action Plan announced in June 2017 by Commissioner Scott Gottlieb
FDA Drug Shortage and Other Initiatives
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• Companies need to have a Drug Shortage Plan in place – build better inventories of finished product and raw materials and components, have a plan for when things fail
• Redundancy in manufacturing and suppliers –encouraging industry to have “warm” lines and components and supplies at the ready for critical drugs
• Better notifications - some firms still do not provide more than the minimum amount of information and provide it at the last possible minute
• More capacity, additional manufacturers making critical drugs
What’s still needed?
Email: [email protected] or 301-796-0737
General Email: [email protected]
Phone: (240) 402-7770
THANK YOU!
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Federal Food, Drug, and Cosmetic Act (FD&C Act), Section 506C (21 USC 356c, as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA, 2012), Title X–Drug Shortages), Public Law 112-144: https://www.gpo.gov/fdsys/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf
Federal Register Final Rule, 80 FR 38915 (July 8, 2015), Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products. https://federalregister.gov/a/2015-16659.See also 21 CFR 310.306, 314.81, and 600.82.
CDER MAPP 4190.1 Rev. 2, Drug Shortage Management (11/1995; Rev. 1, 9/2006; Rev. 2, 9/2014): https://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/ucm079936.pdf
Executive Order 13588 (October 31, 2011), Reducing Prescription Drug Shortages: https://obamawhitehouse.archives.gov/the-press-office/2011/10/31/executive-order-13588-reducing-prescription-drug-shortages. On October 31, 2011, FDA also sent a letter to drug and biologic manufacturers, encouraging them to voluntarily report potential shortages to FDA.
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References
Healthcare and Public Health Sector Supply Chain Preparedness and Response
Laura K. Wolf, Ph.D.
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HEALTHCARE AND PUBLIC HEALTH SECTOR SUPPLY CHAIN PREPAREDNESS AND
RESPONSE
Laura K. Wolf, PhDBranch Chief, Critical Infrastructure Protection
HHS Office of the Assistant Secretary for Preparedness and Response
Resilient People. Healthy Communities. A Nation Prepared.
Healthcare and Public Health Sector Critical Infrastructure Partnership
By providing a venue for public and private sector partners to collaborate, we
Promote risk management activities;
Share threat information;
Socialize best practices; and
Develop useful tools and policies;
to mitigate impacts of disasters and enhance resilience of the entire health care system to minimize disruptions in care for all Americans
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Resilient People. Healthy Communities. A Nation Prepared. 23
Healthcare and Public Health Sector Critical Infrastructure Partnership
2017-2018 Priorities• Supply Chain• Cybersecurity• Risk Assessment• Response/Exercises
Resilient People. Healthy Communities. A Nation Prepared.
Partnering to respond to evolving threats
FDA
VA
DoD
CDC
ASTHO
NACCHO
Public Sector
PHEMCE
Global Supply Network
for Pandemic
Preparedness and Response
All-Hazards Consortium
Coordinating Groups
American Hospital Association
American Society of
Health-System Pharmacists
Healthcare Distribution
Management Association
Private Sector
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Resilient People. Healthy Communities. A Nation Prepared.
Role in Response
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CIP supports national ESF-8 response Sits in HHS Secretary’s Operations Center
Sector-wide calls daily during events
Coordination with trade association partners
Outreach to affected organizations
Coordinated messaging across sector
Partner reach has expanded into the hundreds of thousands
Coordinating with FEMA to support private sector
Resilient People. Healthy Communities. A Nation Prepared.
HHS/FEMA support to Puerto Rico
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CIP considers all healthcare industry and public health in response efforts, not just hospitals, and advocates for support DHS/FEMA generally does not provide
assistance for for-profit companies
For-profit companies are critical to Puerto Rico’s recovery and to national healthcare
Partnered with FDA to prioritize available resources for manufacturing
Ongoing challenges
• Power restoration
• Medical gas availability
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Resilient People. Healthy Communities. A Nation Prepared.
Supply Chain Preparedness Activities
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Support to supply chain resilience more broadly Working with government partners to identify additional authorities that
can support FDA Drug Shortage Program efforts to
• Prepare for;
• Prevent; and
• Respond to shortages
American Society for Health-System Pharmacists and Association of State and Territorial Health Systems
• Recommendations
Private sector partners- engaging with industry to provide tools to better help them prepare for disasters
Resilient People. Healthy Communities. A Nation Prepared.
ASPR’s TRACIE
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ASPR TRACIE: asprtracie.hhs.gov Technical Resources, Assistance Center, and Information Exchange
Wide variety of information resources
Drug Shortages page• https://asprtracie.hhs.gov/technical-resources/53/pharmacy/47#drug-shortages
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Resilient People. Healthy Communities. A Nation Prepared.
Partnership Engagement
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Weekly Highlights Newsletter
Innovation Seminar Series
Bi-annual Public-Private Partnership Meetings
Response Coordination
Phe.gov (ASPR) twitter, facebook
ASPR blog posts
Response/incident communications
Pilot: Podcast
Phe.gov/cip
Roslyne [email protected]
CAPT Valerie Jensen [email protected]
Laura Kwinn Wolf, [email protected]
Questions?
