How the money flows at haematology and oncology FDA workshops.

Financial conflicts of interest among presenters, panellists and moderators at haematology and oncology FDA workshops.

The US Food and Drug Administration (FDA) is the regulatory agency that grants marketing authorization to novel drugs, devices, and medical products. FDA commissioners are not allowed to receive direct money from the industry, in order to prevent them from any undue influence. However, there are many other ways at the agency – often not as visible - which may lead to some kind of financial conflict-of-interest (COI).

Financial COI have been shown to influence physician prescribing practices and social media behavior. High rates of financial conflicts among speakers at FDA advisory committee meetings and experts testifying on behalf of drug companies have raised concerns over the integrity of the drug approval process and the erosion of public trust in that process.

In our recent paper published in the European Journal of Clinical Investigation, we examined financial COI among presenters at hematology and oncology workshops held jointly with the US FDA.

Workshops serve a distinct purpose from advisory committee meetings, as these are not tied to specific drug products, but broader regulatory frameworks in a disease condition. 

We focused on 4 questions

1. Financial conflicts of interest among US-based physician presenters, moderators, or panelists measured using the Center for Medicare & Medicaid Services (CMMS) Open Payments database.

2. Financial conflicts of interest of patient advocacy organizations represented at the workshops.

3. Financial conflicts presented by revolving door politics, whereby regulators seek employment in the pharmaceutical industry after their service.

4. Disclosures of financial conflicts presented during the workshops. 

Financial Conflicts of US-based Physicians

Of the 273 individual US-based physician presenters, 78% (n = 213) had received at least one payment during the study period. We analyzed general payments, which are not associated with research funding, and found that the mean payment in our study population was $16,434 per year. This exceeds the mean payment of $7,750 per year for an average physician in the field.

The Figure below represents the average yearly general payments received by US-based physician Presenters, moderators, and panelists, with the top 3% receiving above $100,000 per year.

Financial Conflicts of Patient Advocacy Organizations, Revolving Door Politics, and the Disclosure of Conflicts

Of the 118 patient advocates representing 52 organizations, 69% spoke on behalf of organizations that received financial support from the pharmaceutical industry. Among all presenters representing a regulatory agency, we found that 18% later went on to work for the pharmaceutical industry.

We obtained information about disclosures of conflicts from 92 presenters. Of these, 50% (n = 46) had a disclosure slide or verbally indicated whether they had a conflict of interest. Among those who did not present a disclosure slide or verbalize their disclosures, 33% (n = 15) had previous payments from industry. 

Conclusion

Workshops held jointly with the US FDA bring a diverse set of stakeholders together in order to discuss challenges facing the field and to shape future regulatory and treatment strategies. Though people who serve on advisory committees for the FDA are not allowed to have direct conflicts of interest, it is unclear if or how these rules apply for individuals who present at workshops. Our work suggests that the US-based physicians who present at these meetings receive higher average payments compared with an average physician in the field and that disclosures of conflicts of interest during the workshops are inconsistent. 

Check out the full paper here.