The PPLA is the leader in advancing patient safety through the use of printed medical information
In 1938, Congress passed the United States Federal Food, Drug, and Cosmetic Act, which gave authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics.
This act of Congress stipulated that every drug product must have labeling consisting of “written, printed, or graphic matter” that is placed “upon the immediate container of any article” and that “bears adequate directions for use” and “adequate warnings.”
In the 75+ years since that landmark legislation, the pharmaceutical industry in the United States has grown exponentially and so has the critical need for conveying information about the tens of thousands of medications Americans depend on every day.
While not only improving and saving lives, these powerful medications have also resulted in deaths and adverse events because scientifically accurate and understandable information about them was not readily available in printed form.
It is essential to protect the health and safety of the millions of Americans who depend on prescription drugs by demonstrating the necessity for delivering this critical information on paper.
The content and wording of package inserts are reviewed and approved by the FDA and must include full prescribing information, covering dosage, administration, warnings, precautions about side effects, adverse reactions, and drug interactions.
The PPLA is comprised of member companies that print or otherwise support the printing of the legally mandated package inserts (PI) (referred to as the “Labeling Content” in the 1938 legislation) that pharmaceutical manufacturers supply with their drugs. The PPLA believes that printed PI is critical to the health and safety of American patients who benefit from taking prescription medications.
Indeed, patient safety is our business.