Researchers Find Most Expert Speakers at FDA ODAC Meetings Receive Sizable Industry Payments

Posted 05 July 2017 By Zachary Brennan

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Experts speaking on behalf of a pharmaceutical company at US Food and Drug Administration (FDA) Oncology Drug Advisory Committee (ODAC) meetings often receive hefty sums, raising questions about the relationships between the companies and the experts ahead of three ODAC meetings next week.

“We found that most (92.1%) expert speakers at FDA ODAC meetings receive sizable industry payments (median, $35,435). We were unable to establish payments made from the specific sponsoring company to 20 of the 38 experts (52.6%), which may be a result of the limited time frame in which payments were reported,” researchers from Oregon Health & Science University said in a Letter to the Editor in Mayo Clinic Proceedings published Wednesday.

The researchers considered 35 ODAC meetings from 2011 to 2015, and of 38 experts who were based in the US and had an MD degree, 35 (92.1%) received industry payments while 18 (47.4%) received payments from the specific sponsor involved in the meeting.

“We found that among the elite experts at ODAC meetings, strong correlations exist between metrics of academic success (publications/citations/h-index) and industry payments. After adjusting for seniority, these correlations remained significant (P<.001),” the researchers said.

“These results raise the question of whether the industry pursues highly influential physicians or whether the acceptance of financial conflict improves one's academic output, through publications derived from collaboration. Future work is needed to explore the direction of this relationship,” they concluded.

The letter also noted that the Physician Payments Sunshine Act's disclosure requirement does not apply to pharmaceutical companies that do not yet have a product on the US market, which includes several sponsors examined.

ODAC Meetings Next Week

FDA’s ODAC is set to meet next Tuesday, to discuss Pfizer’s biologics license application (BLA) for Mylotarg (gemtuzumab ozogamic) in combination with daunorubicin and cytarabine for the treatment of adult patients with previously untreated, de novo acute myeloid leukemia, Wednesday, to discuss Novartis’ BLA for its CAR-T cell therapy to treat pediatric and young adults with relapsed/refractory B-cell acute lymphoblastic leukemia, and Thursday to discuss Amgen’s proposed biosimilar to Roche’s Avastin (bevacizumab).

Five members of Thursday’s meeting received waivers related to conflicts of interest so they could participate in the meeting.

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Categories: Biologics and biotechnology, Drugs, Ethics, Regulatory strategy, Regulatory intelligence, News, US, FDA

Tags: ODAC, Oncology Drug Advisory Committee, FDA advisory committees

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