Package inserts are labeling directed at healthcare professionals. Historically, the FDCA had left it up to prescribers and dispensers to determine what written drug information should be provided to patients for prescription drugs. This policy changed somewhat in the mid-1970s, however, because the FDA believed that PPIs should be mandated for certain prescription drugs, and enacted regulations to this effect. The regulations angered pharmacy organizations, which were primarily concerned about the logistics, cost, and effort of storing and distributing these PPIs.

As you read this case, consider whether PPIs are necessary to protect the health and safety of patients prescribed estrogen drugs. Is it an unjust governmental intrusion for the government to dictate to healthcare providers what information they should tell patients?

On what basis does the FDA have the regulatory authority to require patient information?

Should PPIs be required for all prescription drugs?

Is there a need for uniformity in the written information provided to patients by pharmacists?

How does the Medication Guide program differ from the PPI program?

Should pharmacy be supportive of or opposed to the Medication Guide program and why?