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US medicine regulation reforms passed by House

The 21st Centrury Cures Act could make sweeping changes if ratified


Proposed legislation designed to make new therapies accessible to patients more quickly has been cleared by the US House of Representatives.

The House voted 344 to 77 in favour of the 21st Century Cures Act (HR 6), a broad-ranging piece of legislation that would require the FDA to develop a more streamlined approval process for new medicines as well as many other changes affecting pharma and medical device regulation. 

The legislation still needs to be matched by a Senate proposal and signed into law by President Barack Obama before it can come into effect. The chair of the Senate's presiding Health, Education, Labor and Pensions Committee - Sen. Lamar Alexander - suggested it should have a bill drawn up by the end of the year.

In the meantime, the endorsement by the House was applauded by the Pharmaceutical Research and Manufacturers of America (PhRMA), which said HR 6 “will help to enhance the FDA's ability to adapt to cutting edge technologies utilised by America's biopharmaceutical companies to bring new medicines to patients and their healthcare professionals”.

The bill's backers - including Republican Rep. Fred Upton who chairs the House Committee on Energy and Commerce - claim the reforms are needed to improve the take-up of new medical innovations and update the federal drug and device approval apparatus which are “in many ways the relic of another era”.

Funding boosts 

Among the key elements of HR 6 is an extra $8.75bn in funding for the US National Institutes of Health (NIH) over the next five years - a sizeable boost on its $30bn budget - including an NIH innovation fund for ad hoc projects.

The additional money will be used to accelerate new projects such as President Obama's Precision Medicine Initiative, which is aimed at accelerating the development of personalised medicine based on people's genes, as well as an initiative to foster the development of young scientists.

Meanwhile, the FDA stands to receive another $550m over five years if the bill becomes law, to help it fund a host of new responsibilities including measures aimed at putting patient perspectives at the heart of its decision-making, for example by including patient experience data into its review process.

It would introduce a streamlined data review process, for example by allowing a drug that has been approved in one indication a truncated approval route for a second. According to HR 6's supporters, this could dramatically accelerate the roll-out of new cancer therapies.

Speeding up reviews

If adopted in its present form, the bill will also ask the FDA to publish additional information and guidance on the use of biomarkers and surrogate markers to hasten drug development, and encourage the use of new methods in clinical trials such as adaptive designs and registries. 

The latter in particular has proved somewhat controversial however, with some raising concerns that this is devaluing randomised clinical trials as the standard for testing safety and efficacy and could lower standards.

It will also introduce new incentives for the development of drugs for rare diseases and antibiotics, and remove “regulatory uncertainty” in the development of medical apps, say its authors.

"Our 21st Century Cures effort seeks to capture just a sliver of hope and optimism that countless patients exude despite sometimes insurmountable odds,” said Upton, who co-sponsored the bill with Democrat Rep. Diana DeGette. 

“They need the next generation of treatments and cures, but they do not have until the next generation to wait.”

The cost of the reforms would be underwritten through the sale of 64m barrels of the US's crude oil reserves, raising more than $5bn, according to Upton. 

The US initiative comes as the European Commission has been criticised by pharma groups for its decision to divert funding from R&D and into the European Fund for Strategic Investments (EFSI) set up by Commission President Jean-Claude Juncker.

Article by
Phil Taylor

13th July 2015

From: Regulatory



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