FDA

The FDA is coming down hard on pharma following generic drug stalling tactics. This follows the recent publication from the agency of an online list of pharma companies that together have racked up 150 complaints from generics makers seeking samples.

This might be public shaming for pharma, but it is unlikely that it’s going to stop the broader damage to the reputations of companies and brands named, writes Fierce Pharma. As expected, the publishing of the document did result in a slew of media coverage dropping phrases such as “shame and name” or “gaming the generic drug system,” along with some minor social media buzz.

Companies on the list have felt the repercussions, which have taken the form of stock price drops. Whilst long-term damage is likely, Mark Senak, Eye on FDA blogger and public relations professionals, suggests that several mitigating factors may dampen the impact. 

Generics competition is just one of many issues that could knock pharma’s reputation, and this is far from the biggest one. Senak also believes the list is just part of the story around generics and maybe “provides the beginning basis for conversation, but not the conclusion.”

In addition, the FDA already publishes a lot of information about pharma companies that haven’t usually resulted in long-term reputation damage. However, he noted, “In the end, it may be a matter of scale – how often a company appears on the list and with how many letters over the course of how many products whereby the character of a company may become a focus rather than being named once.”

But, this doesn’t mean that pharma companies should sit back and relax. Senak added that they should develop an approach and be prepared to discuss it if asked about their track record working with generic drugmakers. 

“Developing a statement of principles to publish with regard to one’s corporate approach to generic development might not be a bad idea,” he concluded. “In the reactive sense, they should be able to enunciate a rationale for their action or explanation of the circumstances whereby a letter of complaint may have been sent. A letter alleging complaint by itself is not a conclusion, it is an entree to a discussion so that a conclusion can be reached.”