Congressional Perspectives on the Global Drug Supply Chain

1. Congressional Perspectives on the Global Drug Supply Chain Andrew C. Fish Senior Vice President & General Counsel

2. Political and Regulatory Environment Long standing and growing bipartisan Congressional skepticism of FDA Food Safety Drug Safety (approvals, post-marketing) FDAAA Democratic majority Drug Industry

3. Catalysts Food (longstanding issue) DEG (cough medicine, toothpaste) Lead (children’s toys) Melamine (pet food, infant formula & other milk products) Heparin (global, esp. U.S. & Germany) FDA itself

4. Congressional Players - House Rep. John Dingell (D-Mich.) Chair, E&C Rep. Rosa DeLauro (D-Conn.) Chair, Ag Approps Subcommittee Rep. Bart Stupak (D-Mich.) Chair, E&C Investigations Subcomm. Rep. Henry Waxman Chair, Oversight and Government Reform

5. Congressional Players - Senate Sen. Ted Kennedy (D-Mass.) Chair, Senate HELP Committee Sen. Charles Grassley (D-Iowa) Chair, Finance Sen. Dick Durbin (D-Ill.) Majority Whip

6. FDA Under Fire Unforgiving environment (what does safe mean?) Perhaps some political missteps Resources

7. International Inspections & IT GAO Report Findings New FDA appropriations Inspections; field; international; IT

8. What Does Congress Think It Knows? Global supply chain is a Wild West Manufacturers are lax FDA is lax Nobody knows anything Our import safety system is swiss cheese at best Consumers are getting hurt

9. Legislation Drug and Device Accountability Act of 2008, S. 3409 (Kennedy & Grassley) – July 31, 2008 Food and Drug Administration Globalization Act, discussion draft (Dingell, et al.) – July 24, 2008

10. Information is Key Who knows what when? What do manufacturers know? What does FDA know? What do they not know that they should?

11. So…Let’s Mandate Information Collection and Reporting Registration of Drug Establishments Global, AIs plus excipients Registration and Licensing of Drug Importers (Senate) Document transactional history of entire supply chain with information establishing “identity, strength, quality, and purity of the drug” at every stage

12. Information Collection and Reporting, cont’d…(1) AI purity verification (Senate, House dropped) Import documentation: House: provide information “demonstrating compliance with applicable requirements…” Senate: importers must present documentation to FDA, including record of inspections (AIs and excipients) Records and reports of drug defects (Senate) Written certification re information (Senate)

13. Information Collection and Reporting, cont’d…(2) Quality Risk Management Plan (House) Numerous criteria aimed at ensuring manufacturer diligence regarding Vendor qualification and auditing Quality testing Current manufacturing science and good distribution and import practices (Senate) E-pedigree (Senate)

14. Country of Origin Labeling and Information Senate: AIs on label & website House AI in whole or in part on label All ingredients on website

15. Other FDA Authorities Mandatory Recall Authority (Senate) Extraterritorial Jurisdiction (House)

16. Inspections No distinction between domestic and foreign facilities Inspect foreign facilities as often as domestic (Senate) No shipping until initial inspection or follow up inspection when production change (House) Risk-based frequency (Senate 2-5, House 2-4)

17. 111th Congress Bipartisan commitment to legislation Comprehensive bill vs. sector-specific Political dynamics of new administration and balance of power in Congress