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Proceedings from the PEW Charitable Trust
After Heparin: A Roundtable on Ensuring the Safety
of the US Drug Supply and Rx-360's Contributions

The Pew Charitable Trusts hosted a roundtable discussion addressing the safety of the U.S. drug supply. Expert presentations were part of a larger conversation on the issues and solutions raised in a draft white paper entitled, After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs. Participants were provided with this paper in advance of the conference.

Through an examination of today's drug manufacturing, distribution and oversight systems, After Heparin explores the possible pathways for substandard or counterfeit drugs to reach U.S. patients both within the legitimate supply chain as well as through illicit routes. The roundtable discussion provided a platform for dialogue on this important public health matter in addition to informing the final white paper itself, which will be released following the roundtable.

Speakers and participants included members of pharmaceutical, distribution and retail pharmacy industries, as well as representatives from FDA, GAO, USP, Boards of Pharmacy, consumer groups and academic organizations.

Statement: Consumer and Drug Industry Representatives Back New Fees to Cover Inspections

Webcast:
View Webcast from Monday, March 14
View Webcast from Tuesday, March 15
(best viewed in Google Chrome, Safari or Mozilla Firefox)

Download Agenda
View Speaker Biographies

Monday, March 14

Day 1: Globalization of Pharmaceutical Manufacturing: Updating Quality Systems and Oversight

Invited roundtable participants: Food and Drug Administration, United States Pharmacopeia, Pharmaceutical Research and Manufacturers of America, Generic Pharmaceutical Association, Society ofChemical Manufacturers and Affiliates, Rx360, European Fine Chemicals Group, National Institute of Pharmaceutical Technology and Education, International Pharmaceutical Excipients Council, American College of Physicians, American Society of Health System Pharmacists, Community Catalyst, Consumers Union, AARP

Moderator: William K. Hubbard, Advisor, Alliance for a Stronger FDA

Welcome Remarks

Allan Coukell, BScPharm, Director, Medical Safety Division, Pew Health Group
Opening Keynote

John M. Taylor III, Esq., Acting Principal Deputy Commissioner, FDA
Session 1: Ensuring quality and safety across manufacturing supply chains
Panelists:

Martin VanTrieste, Chair, Rx-360, Senior Vice President Quality, Amgen (Presentation PDF)

Roger L. Williams, M.D., CEO, United States Pharmacopeia (Presentation PDF)

Philippe Andre, Auditor and Managing Director of Qualiau Pharmaceutical Auditing Co., Ltd., Associate Professor at the School of Pharmaceutical Science and Technology at Tianjin University, China (Presentation PDF)

Roundtable Discussion
Key Questions:

1. What steps should manufacturers take to safeguard global supply chains?
2. How should companies assess suppliers?
3. Are there policy mechanisms that could improve compliance with quality standards?
4. How can analytical standards and tests be improved?

Session 2: Ensuring sufficient regulatory oversight of foreign manufacturers
Panelists:

Marcia Crosse, Ph.D., Director, Health Care, Government Accountability Office (Presentation PDF)

Brant Zell, Past Chair, Bulk Pharmaceuticals Task Force of the Society of Chemical Manufacturers and Affiliates (Presentation PDF)

Guy Villax, Board Member of the European Fine Chemicals Group and of Rx-360; CEO, Hovione

Roundtable Discussion
Key Questions:

1. How frequently should FDA inspect foreign plants?
2. Is there a role for third-party inspections?
3. What would constitute an effective system for tracking foreign manufacturing sites?
4. How can tracking systems integrate with risk assessment and customs activity?

Session 3: Ensuring a robust regulatory system
Panelists:

Heather Bresch, President, Mylan (Presentation PDF)

Prabir Basu, Ph.D., Executive Director, National Institute of Pharmaceutical Technology and Education (Presentation PDF)

Deborah M. Autor, J.D., Director, Office of Compliance, Center for Drug Evaluation and Research, FDA (Presentation PDF)

Roundtable Discussion
Key Questions:

1. How should FDA oversight of foreign plants be funded?
2. Does FDA need new tools to oversee global supply chains?
3. Are international harmonization and reciprocal recognition of inspections part of the solution?

Concluding Remarks
Allan Coukell, Pew Health Group

Tuesday, March 15

Day 2: Pharmaceutical Distribution: Risks and Responses to Counterfeit and Diverted Drugs

Moderator: William K. Hubbard, Advisor, Alliance for a Stronger FDA

Opening Keynote
Speaker: U.S. Senator Michael Bennet (D-CO)

Session 4: Protecting U.S. drug distribution
Panelists:

Ilisa B.G. Bernstein, PharmD., J.D., Deputy Director (Acting), Office of Compliance, Center for Drug Evaluation and Research, FDA (Presentation PDF)

Cesar Arias, R.Ph., P.I., Partner, Stone Cold Healthcare Consultants, LLC; former druginspector, Florida Bureau of Statewide Pharmaceutical Services (Presentation PDF)

Roger Bate, Ph.D., Legatum Fellow in Global Prosperity, American Enterprise Institute (Presentation PDF)

Roundtable Discussion

Key Questions:

1. Where and how serious are the weaknesses in the distribution system?
2. What are the implications of international counterfeits for the US market?
3. What improvements should be made to penalties for counterfeiting, adulteration, 5. other violations of the FD&C Act?

Session 5: Serialization, pedigree and tracking

Panelists:

Virginia Herold, M.S., Executive Officer, California State Board of Pharmacy (Presentation PDF)

Elizabeth A. Gallenagh, Esq., Vice President, Government Affairs, Healthcare Distribution Management Association (Presentation PDF)

Diane Darvey, PharmD, JD, Director, Federal and State Public Policy, National Association of Chain Drug Stores (Presentation PDF)

Roundtable Discussion

Key Questions:

1. Should there be a universal system for tracking drug distribution?
2. What would the elements of a successful system be?
3. What changes to regulation and oversight of distributors and pharmacies would help identify and deter bad actors?

Concluding Remarks
Speaker: Allan Coukell, Pew Health Group

For media inquiries, please contact Linda Paris, lparis@pewtrusts.org or
(202) 540-6354

To learn more go to: http://www.prescriptionproject.org/after_heparin/