PI Issues

Tell Congress to keep package inserts (PI) printed!

Challenges to the printed PI requirement mandated by the U.S. Food Drug and Cosmetic Act have been underway for years by industry and the FDA. In response to these attempts, the PPLA has worked with Congressional leaders to block any attempt to replace printed PI through the annual appropriations. It is critical that your elected officials hear from you about the importance of printed PI.

All you have to do is:

  1. Find Your Member of Congress
  2. Contact us at for contact information
  3. Email your Member with the note and attachments below.

Make sure your voice is heard!

Subject: Congress Must Protect Paper Prescribing Information  


My name is XXX, and I am the (your title, (optional)) at (company name), residing in your (district/state). As a constituent, I strongly urge your boss to take action to protect printed package inserts (PI). 

Printed PI contains technical and scientific information intended for health care professionals to help prevent fatal drug interactions or adverse drug events. PIs are developed amid the drug approval process at the Food and Drug Administration (FDA) and are required to accompany all prescription drugs from the manufactures to the pharmacy or the clinician’s office. Paper PI provides the critically important information to which health care practitioners commonly refer to in a reliable format. 

Access to printed PI must be preserved for several reasons: 

  1. Internet connectivity is not dependable to access electronic prescribing information; 
  2. Initial searches for an official package insert often link to marketing information first; and
  3. Research supports information on paper leads to improved retention than on electronic devices. 

The House and Senate Appropriations Committees have worked across the aisle to include language preserving printed PI in the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations legislation for Fiscal Year 2020. Despite Congress’ consistent support of this measure, there may be efforts to remove this vital language to ensure professionals have access to paper format PI. I strongly urge you to continue protecting paper prescribing information and advocating for patient safety.

For your reference, please find a letter to Congress from the Pharmaceutical Printed Literature Association (PPLA) and a myth vs. fact page on the PI. 

Thank you for your consideration,