1. FDA Regulation Economically Harmful & Morally Indefensible

2. What Does the FDA Do? Regulates food, drugs, medical devices, etc. For drugs & medical devices 1. Requires reports of many types 2. Requires pre-market approval to sell products Pre-market tests and clinical trials Clinical trials stages I, II, III 3. Regulates manufacturing & marketing practices 4. Requires post-market monitoring & reporting 3. May require product removal from market

3. FDA Regulatory Dynamics

4. Two Types of Regulator Error Product isApprovedNot approved safe & effective OKType I error not safe & effective Type II errorOK

5. Two Types of Risk Use risk Prohibition risk Who should decide how to make trade-off? – Patient whose life and well-being are at stake – FDA reviewer with personal career goals at stake

6. Without FDA Product Bans Patients & their health-care providers decide Many sources of information exist Market competition & reputation check abuse FDA might still certify products & provide information and advice without police power Consumer assistance ≠ coercive paternalism

7. ECRI For more than 40 years, ECRI Institute, a nonprofit organization, has been dedicated to bringing the discipline of applied scientific research to discover which medical procedures, devices, drugs, and processes are best, all to enable you to improve patient care. As pioneers in this science, we pride ourselves in having the unique ability to marry practical experience and uncompromising independence with the thoroughness and objectivity of evidence-based research.

8. ECRI Members &Clients Global Reach Our more than 5,000 member and client list includes hospitals, health systems, public and private payers, U.S. federal and state government agencies, ministries of health, associations, and accrediting agencies worldwide.

9. ECRI Services We deliver research, information, and advice in a variety of ways, including: Customized consulting and collaboration Memberships Publications—journals, alerts, resource guides, newsletters Collecting and analyzing patient safety data, and Investigations