After Heparin: - The Pew Charitable Trusts

TABLE OF CONTENTS
1.4 Problems with domestic controls on supply chain and quality........................................34
1.4.1 Insufficiencies in supplier management..................................................................34
Sidebar 2: Ensuring quality: good manufacturing practices..................................36
1.4.2 Manufacturing quality issues in the United States..................................................37
1.4.3 Challenges involved in testing................................................................................39
1.5 Pew conference and policy recommendations................................................................40
Chapter 2: Barriers to FDA Oversight.............................................................................. 45
2.1 Overview..........................................................................................................................45
2.2 Insufficient scrutiny of overseas manufacturing................................................................46
2.2.1 Foreign and domestic inspection disparities..........................................................46
2.2.2 Over-the-counter products receive less scrutiny.....................................................49
2.3 FDA capacity and information systems............................................................................49
2.3.1 FDA’s inspection staff..............................................................................................49
2.3.2 Limitations of tracking systems and data management..........................................50
2.3.3 Border assessments and importer oversight...........................................................51
2.4 FDA enforcement.............................................................................................................52
2.4.1 Limitations of current enforcement tools and authorities.......................................52
2.4.2 Legal accountability of responsible individuals at companies................................53
2.4.3 Increased information flow to FDA needed............................................................54
2.4.4 Harmonization of international standards and inspections.....................................55
2.5 Pew conference and policy recommendations................................................................56
Chapter 3: Pharmaceutical Distribution............................................................................ 63
3.1 Overview..........................................................................................................................63
3.2 Drug diversion and counterfeit drugs in U.S. distribution................................................64
3.2.1 Diversion, counterfeiting and theft are ongoing problems in the
United States...........................................................................................................64