In February 2009, the Risk Communication Advisory Committee recommended that the Food and Drug Administration (FDA) adopt a single standard document for communicating essential information about prescription drugs, which would replace Patient Package Inserts, Consumer Medication Information, and Medication Guides. FDA developed three draft patient medication information (PMI) prototypes and on May 4, 2010, announced the design of an evaluation strategy in the Federal Register. Following review and approval by the Office of Management and Budget, FDA will evaluate the three prototypes using a consumer testing study.
On July 21, the Engelberg Center for Health Care Reform hosted a one-day workshop focused on improving CMI. Experts from academia, the private sector, and FDA discussed several topics, including:
- Overarching principles for effectively communicating prescription information to patients
- Most useful content and format of a single medication information paper document
- Comments on FDA prototypes
- Metrics for evaluating PMI
- Alternatives to paper-based PMI
On the one hand the U.S. wants to be defending U.S. companies overseas and they are going to see this as vindictive, particularly in going after Apple’s profits retroactively. But in the bigger picture the U.S. is taking moves to fight inversions and improve the global system.