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UK agency urged to ‘press’ EMA on speed reviews

pharmafile | November 18, 2013 | News story | Research and Development, Sales and Marketing BIA, EMA, EU, MHRA 

A new advisory group for the UK drugs regulator wants Europe to follow the lead of the US by introducing speed reviews for new medicines.

In the report published by the MHRA, the Expert Group on Innovation in the Regulation of Healthcare has called for “greater uptake of existing legal flexibilities” to speed up patient access to new medicines in order to address areas of unmet medical need.

The group, established under the Strategy for UK Life Sciences programme in 2011, is recommending that the MHRA ‘press’ the European Medicines Agency (EMA) to launch a call for adaptive licensing at the ‘earliest opportunity’, so that companies can put forward pilot products to use these flexibilities. 

The Expert Group said it also supports the proposed UK early access scheme for unlicensed medicines and urges the government to launch the scheme as soon as possible.

This scheme could potentially allow drugs successful in Phase II to be rolled out in the UK, as long as they meet certain parameters. This is something still in development but an avenue many biotech firms are keen to see in the UK.

Steve Bates, chief executive of the BioIndustry Association, said: “I am pleased to see the expert group supports the idea of an early access to medicines scheme, for which we have long advocated. Now the government must make a funded scheme a reality.

“I am also pleased that the expert group wants the European Medicines Agency to launch a call for adaptive licensing at the earliest opportunity so that companies could put forward pilot products; and that the group proposes the idea of adopting a new breakthrough designation for new therapies both at a UK and EU level.”

‘Breakthrough designation’

This could mimic new rules introduced in the US that has seen 32 drugs granted the so-called ‘breakthrough designation’ by the FDA in the past year, with the first two treatments being given approval under this system in the past two weeks.

This designation speeds up the process for drugs to become available for conditions that have an unmet medical need, such as in multiple myeloma, cystic fibrosis and Duchenne muscular dystrophy.

Bates went on: “If UK patients are to benefit from the most promising new drugs and UK biotech companies are to develop those therapies here rather than overseas we need a similar breakthrough designation scheme here.

“As well as holding the potential to significantly accelerate such treatments to those patients who need them, breakthrough designation has had a positive effect on the companies developing the products and on the investment community’s perception of those companies.”

By allowing a speedier process SME firms such as the ones Bates represents, could potentially lower the cost of their R&D projects and get their medicines onto the UK market more quickly, earning them more money.

The report is now being considered by Ministers at the Department of Health and the Department for Business, Innovation and Skills, with a decision expected in the coming year.

Safety concerns

But with speed comes caution: in October a new study in the Journal of the American Medical Association Internal Medicine found that expedited drugs spent 50% less time in development than those going through the normal process, and were tested in less than a fifth of the number of patients compared to standard drugs.

The study by Thomas Moore of the Institute for Safe Medication Practices and epidemiologist Curt Furberg of Wake Forest School of Medicine, also found that in many instances post-marketing studies that should have been carried out as a condition of early approval remain uncompleted.

Moore and Furberg looked at 20 drugs approved by the FDA in 2008, and compared those given an expedited review by the agency to those approved using the standard review process.

They concluded: “Our findings suggest that the shift has made it more difficult to balance the benefits and risks of new drugs.”

Ben Adams

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