Expert input to FDA on Risk Evaluation and Mitigation Strategies (REMS)

BrookingsA key aim of any research should be to have practical impact – Theo Raynor’s 35 years of research into promoting good consumer medicines information has impacted on policy and practice in the UK and the wider European Union, through input into the European Parliament and the European Medicines Agency. This has been both from an academic perspective at the University of Leeds, and in practice, through his work at Luto Research.

More recently his work has had impact in Australia and the USA, and he has just returned from Washington DC, where he was invited to provide expert input into a meeting of the US Food and Drugs Administration (FDA). The topic was providing risk and benefit information about medicines to patients, something about which Theo and his colleagues have been researching for a number of years. The US authorities are exploring avenues to specifically help inform patients about high risk medicines, and Theo was able to describe previous research into expressing the likelihood of harm from a medicine, and putting this into practice in real-life medicines information through his work at Luto.

The closed meeting took place under the auspices of the prestigious Brookings Institution, close to the White House in Washington DC – one of the most influential ‘think tanks’ internationally. Theo was the only invited expert from outside North America. He was joined at the meeting by Professor Mike Wolf from Northwestern University in Chicago, who is also academic advisor to Luto Research.

FDA Basics Webinar: A Brief Overview of Risk Evaluation and Mitigation Strategies (REMS)