As a standard of practice, manufacturers perform internal reviews of their advertising (and/or this work is contracted externally to consultants or law firms of their choosing). This work is important, and at times critical, but it must not be confused with an “independent” review. If that individual or entity was in fact independent from the manufacturer, there would be no reason to object to that same individual/entity concurrently getting compensated for doing similar work on directly competing brands.
The original architects of the PAAB Code understood that there is a level of impartiality that only comes with independence. Contrary to the internal work or externally contracted work described above, a PAAB review is not predicated on what’s best for any individual manufacturer. Rather, it is predicated on what is best for patients within the confines of all applicable federal regulations. Ultimately, this should be seen as aligning with the interests of the industry as a whole.
This is why distribution/dissemination of an APS within the scope of sections 1.3 and 1.4 that is not expressly exempted in section 1.5 is a contravention of the PAAB Code UNLESS this APS has undergone independent preclearance by the PAAB.
The importance of independence and impartiality is easily conveyed with a sports analogy. Impartiality is a critical expectation for referees who rule on game conduct that constitutes a “penalty” in hockey or football (or a “foul” in basketball). Many of the penalty/foul decisions will, almost by necessity, frustrate one or both teams and their respective fans. Nonetheless, it is hard to imagine that a league could thrive with games officiated exclusively by staff members (or a contracted vendor/agent) belonging to one of the two teams on the field. Independence and impartiality are not small details. Along with specialized knowledge of the rules, they are the centrepiece of judgment in sports officiating and in preclearance review alike.
October 6, 2022