FDA/EMEA exchange programme TAKES NEXT STEP
- Personnel news, including the EMEA/ FDA Exchange
- Hot topics – update on biosimilars and how new medicines should be benchmarked
- The US industry perspective
Sweden 7-9 October ––Hilda Boone, Scientific Administrator at EMEA, is on her way to join the FDA as the promised exchange programme taking robust, bilateral engagement to a new level goes live, reported Murray Lumpkin, Deputy Commissioner (International and Special Programmes) US FDA at the TOPRA Annual Meeting FDA Update Session. Janice Soreth, Deputy Director, Europe/US FDA and Liaison to EMEA arrived in Europe in Summer 2009.
Murray Lumpkin commented: “There is no job description – (Hilde and Janice) are forging new territory.”
Insights on key personnel changes with the Obama Administration were also revealed by Lumpkin: “Dr Margaret Hamburg, our new FDA Administrator, likes to be called Peggy and that says a lot about her. Her strong public health background is quite evident in how she views her job as FDA Commissioner, bringing the mindset ‘how is this affecting the lives of everyday Americans across the USA?’”
Reflecting on the priorities in Congress, Lumpkin remarked: “Food – the F in FDA – is the area of greatest focus. Until the big food bill goes through, Congress will not attend to drugs and other medical products legislation.”
Lumpkin went on to explain that the US business model for generic drugs is rooted in interchangeability and substitution for innovator products, and those accustomed to this are looking at biologics and ask ‘how can we bring down the cost?’.
“Unlike Europe, the FDA does not yet have the authority to authorise follow- on biologics, what we call in the chemical world ‘generic’ drugs. It’s a complex issue and one that we hope will be resolved during this session of Congress, though there are no guarantees on that,” Lumpkin commented.
Concluding his session Lumpkin sought to allay any misperceptions about a new piece of US legislation: “People are under the impression that Congress added a comparative effectiveness hurdle and that is not the case. What Congress did say is that they are very interested in this concept of comparative effectiveness and in outcomes data, and they have provided significant funding to enable us to study how we can get better data.”
Don Kennard, VP of Regulatory Affairs and Quality, Halozyme in San Diego offered the industry perspective. He observed: “The FDA recently ranked second from the bottom in a poll and lower than the IRS. We reckon it is probably because of food issues and its one of the issues we have in the US that our ministry of health is not just health.”
Kennard reported that the US is trying to catch up with the EU on biosimilars . A pathway for biosimilars will be created and the FDA will have the authority to waive clinical investigations based on the data and the FDA expertise.
Biosimilars will have their own trade name and a hybrid of the innovator’s label and their own product specific details and their own clinical data – which is going to be interesting! The FDA will establish interchangeability via the orange book.
“Here’s the hard part – the science,” Kennard commented: “The degree of the biosimilars’ sameness in comparison to innovators will drive the extent and nature of the required clinical trials.”
He also reported issues in relation to comparative effectiveness citing an example of a device or a drug to remove a clot after acute ischaemic stroke. Kennard observed: “Are the standards the same? Are we really doing the thing we should for our patients and is the drug that much more dangerous that we need to do more? ”
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