Some 20 years after the Food and Drug Administration Modernization Act introduced Section 114 (FDAMA114), which amended the Food, Drug and Cosmetic Act, the FDA issued a guidance on the law.
“FDAMA114 allowed manufacturers the ability to communicate truthful and non-misleading health care economic information (HCEI) based on competent and reliable scientific evidence to formulary committees or similar entities, provided the HCEI was related directly to the product’s approved indication,” Ruth Trzcienski writes in Value and Outcomes Spotlight.
But that didn’t come before Dec. 13, 2016, when the 21st Century Cures Act was signed into law. Those still waiting roughly 20 years for guidance on FDAMA114 were reinvigorated since the topic of health care economic information was specifically addressed in the law. In a little more than a month, the FDA finally issued a draft guidance titled “Drug and Device Manufacturer Communications with Payers, Formulary Committees and Similar Entities – Questions and Answers.”
The guidance was meant to help manufacturers understand ways to better communicate HCEI with payers and other entities.