In anticipation of the upcoming G8 Summit this week I released a Policy Innovation Memo, Ensuring the Safety and Integrity of the World's Drug, Vaccine and Medicines Supply – a Matter of Urgency for the G8/G20 Leaderships. This, and two subsequent blogs, will explain why this issue is urgent, how we addressed it at the Council on Foreign Relations, and what I conclude the G8 and G20 leaders can do to save millions of people from toxic, substandard, contaminated, mislabeled and dangerous drugs, medicines and vaccines.
Before her May 2009 swearing-in as Commissioner for the United States Food and Drug Administration (FDA), Dr. Margaret Hamburg did the sort of due diligence necessary to face interrogation by opposition party members in Congress. Traditionally the FDA had been a lightning rod for partisan controversy, and a target for anti-regulation politicians that favor free market solutions to safety issues. As she studied mountains of documents and listened to experts both in and out of government, Hamburg was struck by the dramatic changes globalization had wrought. In our conversations that spring, the fellow-New Yorker expressed mounting anxiety about the shrinking domestic pharmaceutical and vaccine share of the U.S. market, and soaring contribution from overseas. How, she wondered, could an almost 100 percent domestically-focused agency like the FDA protect the populace from what was rapidly becoming an overwhelmingly imported supply of drugs, vaccines, injectibles, medicines, supplements, and over-the-counter treatments?