Globalization, Challenges, and Global Solutions

Transcription

1 Globalization, Challenges, and Global Solutions Deborah M. Autor, Esq. Director, Office of Compliance Center for Drug Evaluation and Research IOM Meeting on Strengthening Core Elements of Regulatory Systems in Developing Countries March 2, 2011

2 Agenda Globalization and Threats to Global Drug Products Issues We Face What Can be Done? What is the Benefit? Examples of What FDA is Doing Now Hopes for IOM Study Conclusion Thank You 2

3 Challenges of Globalization: Many Drugs Are Produced Abroad No registered establishments 1-50 registered establishments registered establishments registered establishments 200+ registered establishments (Source: GAO Report T on Drug Safety. Foreign firms registered to manufacture drugs for the U.S., FY2007) 3

4 Increased Complexity of Drug Supply Chain Creates Many Opportunities for Threats to GLOBAL Drug Products 4

5 Issues FDA Faces Globalization Complex supply chains leading to multitude of vulnerabilities, threats and data/information gaps. Continued migration of manufacturing and drug development overseas. Increase in drug imports and foreign clinical trial data Difficulty in creating one harmonized set of standards out of divergent ones. Developing countries are understandably concerned that over-regulation will stifle economic growth. Some of our regulatory counterparts have an economic mission that may conflict with a public health mission. Cultural differences. Outdated legal authorities to deal with emerging issues Strategic/efficient use of limited resources, finding points of leverage and other providers of assistance 5

6 Issues Developing Country Regulators Face Inadequate regulatory authority and regulatory systems to assess and regulate drugs Lack of resources to establish and maintain effective regulatory and scientific review systems Prohibitively high cost of medicines High taxes/tariffs that drive up the cost of legitimate drugs. May result in susceptibility to low cost counterfeit/substandard drugs. Unstable government/regulatory environment Lack of adequate civil and criminal liability 6

7 Issues We All Face We all face similar issues with fraudulent, substandard, and/or intentionally adulterated GLOBAL drug products China, 2009: Counterfeit diabetes drug containing six times the normal dose of glibenclamide is associated with hospitalizations and death. USA, 2008: Contaminated Heparin that contained active pharmaceutical ingredient from China is associated with serious injuries and death. Nigeria, 2008: Teething syrup contaminated with diethylene glycol associated with deaths in children. Panama, 2006: Diethylene glycol found in cough syrup associated with kidney failure and death. Limited resources 7

8 What Can be Done? All countries should work globally to strengthen global regulatory capacity because no one has the resources to inspect every drug product imported/exported and every drug firm Global Alliance of Regulators. Global Data-Sharing, Data-Mining, and Advanced Analytics. More Use of Third Parties (Public and Private). Those countries with the greatest experience and resources must work together with developing countries to help build regulatory capacity 8

9 What is the Benefit? Strengthening of a country s regulatory capacity has domestic and international benefits Enhances public health locally and abroad. Increases safety/value of imports/exports. Raises overall economy/national prosperity which results in elevation of national and international security. Creates high value jobs in regulatory science. Fosters innovation. 9

10 Examples of What FDA is Doing Now Dedicated Foreign Inspectors FDA posts in Americas, Europe, India, and China Create opportunity for foreign exporters to better understand FDA s standards, regulations, and procedures. Allows the Agency to work closely with regulatory counterparts. Pharmaceutical Inspection Cooperation Scheme (PIC/S) Drug Integrity and Security Program (DISP) Collaboration with European Medicines Agency (EMA), Therapeutic Goods Association (TGA) Collaboration with World Health Organization, Permanent Forum on International Pharmaceutical Crime, and NGOs to address counterfeits Drugs@FDA provides reviews of approved drug products President s Emergency Plan for AIDS Relief (PEPFAR) CDER Forum for International Drug Regulatory Authorities Harmonization Initiatives International Conference on Harmonization (ICH). Asia Pacific Economic Cooperation (APEC). Pan American Network for Drug Harmonization (PANDRH). 10

11 IOM Report on Strengthening Core Elements of Regulatory Systems in Developing Countries Will hopefully Be forward-looking. FDA needs a plan to meet the challenges of the future (10+ years from now), as well as a plan for meeting the challenges of today. Create a plan that complements the global alliance that FDA seeks. Devise a strategy that will produce tangible, measurable results. Propose metrics by which FDA can measure success. Look broadly for other parties (public and private) that can help build regulatory capacity. Plan for transition to in-country ownership. Discuss minimum global baseline practices that are needed to ensure drug quality and security. Provide guidance to the Agency on how to efficiently utilize resources. What should we do more of, less of, start, and stop doing? 11

12 Conclusion Globalization has led to threats to global drug products that we all depend on We may have some differences in the issues we face with regulating drugs, but we share common threats to our drug supply We must come together and work globally to protect global drug products that we all use Strengthening regulatory capacity in developing countries results in safer drugs for everyone 12

13 Thank You 13