Is the FDA Still Regulating Big Pharma Marketing?

by | Mar 18, 2016 | FDA | 0 comments

The US Food and Drug Administration (FDA) sent a record low of enforcement letters to big pharma companies in 2015. Are pharmaceutical companies finally following the rules? Or is the FDA playing it fast and loose with regulating big pharma marketing practices?

What The FDA Is Supposed to Do

The FDA is in charge of regulating advertisements for prescription drugs as well as some medical devices and procedures via its Office of Prescription Drug Promotion (OPDP). When the OPDP determines that a pharmaceutical company has engaged in improper marketing of a drug, it issues an enforcement letter to the offending company.

Record Low of FDA Enforcement Letters Sent in 2015

Last year the FDA sent out the fewest enforcement letters about big pharma marketing than at any other time in its history, according to the Pharma Marketing Blog. Industry watchers have differing theories as to why the FDA is sending fewer and fewer enforcement letters each year, such as:

  • Big Pharma companies are now savvy about promotion laws and know how to work around them, so only smaller drug companies are pushing the marketing envelope.
  • Since the FDA is still trying to figure out how to regulate the fairly new social media environment, pharmaceutical companies are slow to adopt the new marketing possibilities and are taking fewer risks.

Is Money Behind the FDA’s Low Enforcement Rate?

Another possibility for the FDA’s reduction in warning letters could be that it’s (unofficially) trading favors for fees. The evidence supporting this theory lies in the money earned by the FDA from the Prescription Drug User Fee Act (PDUFA).

The PDUFA allows pharma companies to pay fees to “fund the drug approval process.” This law essentially allows a company to fast-track FDA approval for a drug if it pays enough money.

The Correlation Between PDUFA Fees and Enforcement Letters

It seems that the more money the FDA rakes in from PDUFA fees, the fewer enforcement letters it sends out – which is easily seen on this graph of fees paid vs. number of enforcement letters sent.

Given this evidence, it’s entirely possible that the FDA has adopted a more hands-off approach to regulating big pharma marketing.