U.K. looks to FDA 'breakthrough' status for inspiration in regulatory revamp

The United Kingdom government has established the scope of the hotly anticipated review into the development and reimbursement of drugs. And the independent panel is being tasked with looking beyond the U.K.'s borders for inspiration, with an analysis of what can be learnt from FDA's "breakthrough" designation on its to-do list.

Sir Hugh Taylor

Life sciences minister George Freeman previewed the review last year, but the composition of the panel that will lead the investigation and concrete details of its scope is only just emerging. As part of its work to map drug development today and identify ways in which it can be improved, the panel will analyze best practices overseas. The government singled out the "breakthrough" status as a topic worthy of investigation. By analyzing the global situation, the government hopes to learn whether the U.K. has innate advantages it can leverage and how it can become a gateway to the European market.

Aspects of the push to turn the U.K. into the obvious starting point for European drug development and commercialization programs are already underway. The Early Access to Medicines Scheme (EAMS)--which allows companies to market certain drugs in the U.K. before they are licensed in Europe--fits in with this strategy. Merck ($MRK) became the first company to have a drug accepted into EAMS this week when the Medicines and Healthcare products Regulatory Agency backed its anti-PD-1 melanoma therapy, Keytruda.

Figuring out the best way to integrate EAMS with the National Institute for Health and Care Excellence (NICE) is one of the tasks awaiting the panel. Being accepted into EAMS suggests a drug is effective in an underserved population, but it could still fail to meet NICE's criteria for reimbursement. Coming up with a solution to these and other problems will fall on Guy's and St. Thomas' NHS Foundation Trust Chair Sir Hugh Taylor, who the government has tasked with leading the review. Oxford University professor Sir John Bell is heading up the expert advisory panel that will support the process.

- read the government release
- check out the review outline (PDF)
- and the Merck release

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