Expanded access to experimental medicines is a highly contentious issue - and for all the wrong reasons. The paper from the Goldwater Institute, "Everyone Deserves the Right to Try: Empowering the Terminally Ill to Take Control of their Treatment," upon which much of the state legislation discussed in the June 30 BioCentury cover story is based, points the finger at FDA as a roadblock to access: "Sadly, over half a million cancer patients and thousands of patients with other terminal illnesses die each year as the bureaucratic wheels at the FDA slowly turn."

Nothing could be further from the truth. According to FDA's own data for the fiscal year ended last October, the agency approved 863 requests, or 99% of all expanded access requests. And one-third of those were approved on an emergency basis. In fact, the agency has approved 99% of all requests since October 2009. On average, 932 requests were endorsed annually since then.