No such thing as a free expert, GAO tells FDA in heparin conflict of interest case

A new code of conduct introduced by the US FDA after extended criticism of the agency's response to the 2008 heparin crisis will alter the way the FDA interacts with industry personnel who volunteer help and advice to deal with "emergencies" such as suspected drug contaminations. A Government Accountability Office (GOA) report released last month claims that the FDA did not recognise or did not respond properly to the potential conflicts of interests that arose from its working with industry-associated personnel. The GOA recommended that the FDA needed to tighten its paper trail under such circumstances, and the agency responded by amending its staff guidance notes with a section on "External Expert Gratuitous Services in an Emergency".

A new code of conduct introduced by the US FDA after extended criticism of the agency's response to the 2008 heparin crisis will alter the way the FDA interacts with industry personnel who volunteer help and advice to deal with "emergencies" such as suspected drug contaminations. A Government Accountability Office (GOA) report released last month claims that the FDA did not recognise or did not respond properly to the potential conflicts of interests that arose from its working with industry-associated personnel. The GOA recommended that the FDA needed to tighten its paper trail under such circumstances, and the agency responded by amending its staff guidance notes with a section on "External Expert Gratuitous Services in an Emergency".

The GAO concerns were described in a 63-page report issued at the end of October. Although the document commends the...

Welcome to Scrip

Create an account to read this article

More from Archive

Final Chance To Have Your Say: Take Scrip's Reader Survey This Week

 

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access Scrip, or if you love it how it is, now is the time to have your voice heard.

Galapagos Expands Point-Of-Care CAR-T Study To The US

 

CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.

Analysts Split On Eisai’s Chances Of Changing EU Regulator’s Mind On Leqembi

 

A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand

More from Scrip

Novartis Chief Warns Of Fewer Launches And Drug Withdrawals In Europe

 
• By 

Reimbursement rules are disincentivizing innovation, according to Vas Narasimhan.

Executives On The Move: Five New CEOs Among This Week’s Changes

Recent moves in the industry include changes at the top at Ascentage Pharma, Inventiva and Brenig Therapeutics, plus five companies get new CFOs.

AI-First, Big Pharma, Chinese Firms In Race - What’s Ahead For PRMT5 Inhibitors

 
• By 

As AI-driven firms like Insilico, big pharma like J&J, Amgen, GSK and AstraZeneca and Chinese and Indian firms like BeOne and Dr. Reddy’s respectively advance PRMT5 inhibitor candidates, what’s driving interest, what could lead to the first global approval and what are the challenges ahead?