Senior FDA resignations gut drug advertising function

 Two senior officials at the FDA's drug promotion regulatory office have resigned, leading to speculation that a clampdown on some direct-to-consumer (DTC) advertising of medicines could be on the way.

Catherine Gray and Mark Askine, respectively the director and deputy director of the Office of Prescription Drug Promotion (OPDP), have both stepped down effective immediately, according to a report from Politico's AgencyIQ news service.

Citing emails sent by multiple staffers at OPDP, AgencyIQ says that the latest resignations come after two other senior figures at the office's Division of Promotion Policy, Research, and Operations (DPPRO) – director Kathleen David and deputy director Amy Muhlberg – were laid off earlier this month, along with the unit's entire staff.

OPDP's primary task is reviewing prescription drug advertising and promotional labelling to ensure that the information contained in the materials is not false or misleading.

Health and Human Services (HHS) Secretary Robert F Kennedy Jr, who oversees the FDA, has made no secret of his desire to ban prescription drug advertising on television in comments made before his confirmation to the role in February, part of a wider effort to reduce the influence of the pharma industry on public health policy.

That drive to reduce pharma's input was evident last week when new FDA Commissioner Martin Makary announced a new policy directive to remove pharma industry representatives from advisory committees, except where required by statute.

Kennedy has long argued that TV advertising of medicines can drive unnecessary prescribing and inflate US healthcare costs and – whilst running as a Presidential candidate before lending his support for Trump – pledged to order a ban on his first day in office.

As it stands, the US and New Zealand are the only two countries in the world that allow prescription drugs to be promoted via broadcast media.

With leadership at the OPDP now largely absent, the question is whether Kennedy's aim is to convince Makary to recruit people to the roles who share his views on drug advertising and promotion.

A recently published report from the Campaign for Sustainable Rx Pricing (CSRP) suggested that the 10 largest pharma companies in the US spent nearly $14 billion on promotional efforts in 2023, noting that the Congressional Budget Office (CBO) has predicted limiting that would lower prescription drug spending overall.

It concluded that prohibiting or taxing pharma advertising could increase federal tax revenues by between $1.5 billion to $1.7 billion annually from those 10 companies alone.

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