In effect, therefore, what PhRMA is advocating here, is that _narrower_ conception of a company’s responsibility. (Even though the language does not sound like that for folks not familiar with its referents.)

I believe that that’s what is being addressed in this piece of the code:

DTC television and print advertising should be designed to achieve a balanced
presentation of both the benefits and the risks associated with the advertised
prescription medicine. Specifically, risks and safety information, including the
substance of relevant boxed warnings, should be presented with reasonably
comparable prominence to the benefit information, in a clear, conspicuous and
neutral manner, and without distraction from the content.

Atlex

I may be missing your point, but why would the ads be less likely to include safety information than previously? All existing relevant safety information is expected to be addressed in ads already. This piece of the Code simply suggests that if new safety risks come to light, the DTC ad should be altered or pulled. This may not be the most powerful statement ever, but there seems to be nothing inherently wrong with codifying this practice.

Morris

“Working with the FDA, companies should continue to responsibly alter or
discontinue a DTC advertising campaign should new and reliable information
indicate a serious previously unknown safety risk.”

This is pretty much identical language to the new, and more restrictive, CBE regulations. So, in actuality, ads will be _less_ likely to include potentially important risk information than previously. (”Working with FDA,” “new and reliable,” and “previously unknown” are the relevant code phrases.)

How will that be defined, I wonder. An actual label change that must have been approved by the FDA? And a change that meets the much higher bar of causality than the earlier CBE regulation?

Under the current regime, it is hard to imagine companies would be allowed to pull ads because of “new safety or risk info” by lesser critiera.