Article: Mandated Prices in Drug Ads a Legal Minefield

from tHEORetically Speaking: The HealthEconomics.Com Blog at on August 29, 2018 at 05:24PM

As the federal government’s interest continues to grow over the idea of requiring drugmakers to list prices in direct-to-consumers advertisements, any such action could open the door to a wave of legal and Constitutional challenges, according to an article by Washington Legal Foundation’s Cory Andrews.

Andrews in his article published on Forbes suggests the effort, which was officially proposed in the Trump administration’s drug pricing blueprint released in May, is out of the Food and Drug Administration’s realm.

“Not only does FDA lack the statutory authority to impose the mandate, but even if it could legally do so, the regulation cannot survive a First Amendment challenge,” he writes.

Citing a 1962 amendment to the Food, Drug, and Cosmetic Act, the article notes that the FDA’s power over prescription drug advertisements is “unambiguously stated.”

“Neither the FDCA nor the FDA’s implementing regulation contemplates the mandatory listing of drug prices in print or broadcast ads,” Andrews writes. ” … After all, FDA’s legislatively authorized mission is to ensure the safety and efficacy of medical treatments.”

Click here to read the full article on Forbes.