Daily Management Review

Some National Agencies Worried Over EU Rapid Drug Approval Plan


03/29/2017




Some National Agencies Worried Over EU Rapid Drug Approval Plan
Resistance from some of the national agencies that will ultimately decide whether the medicines are worth buying, is being faced by a push by the European Medicines Agency to speed up the approval of new drugs that show promise.
 
Regulators are being pushed to cut through what they see as red tape and adopt more streamlined approval processes for new drugs by pharmaceutical companies, patient advocacy groups and lawmakers around the world.
 
It has been several years that Europe has been looking at new approaches to drug testing.
 
Selling drugs with relatively little testing data, even if the go-ahead comes with strict limits, will expose patients to greater risks have worried critics of new approaches, such as lowering the requirements for lengthy clinical trials.
 
One of the most vocal opponents of such new approaches within Europe has been the  independent authority in Germany (IQWiG) that evaluates new drugs and plays a key role in what price health services pay for them.
 
Not least because drug companies may conclude that dealing with price-setting authorities country-by-country ends up being too costly, its misgivings risk hurting a broader drive to bring new treatments to patients faster given Germany is Europe's biggest drugs market and the fourth in the world.
 
"Accelerated approval on the basis of reduced data should be limited to special situations. But there is reasonable concern that it is intended to become the norm," said Stefan Lange, the deputy director of Germany's Institute for Quality and Efficiency in Health Care (IQWiG).
 
Saying they were not statistically valid. This has resulted in some drugs not getting launched in Germany, or being withdrawn soon after their launch, the agency has in the past rejected pivotal studies that had convinced the EMA to approve a drug.
 
new tools that can forecast better which patients can be helped, and which cannot and advances in genetics that are yielding previously unknown treatments for serious conditions are the primary reasons for the push to adapt the approval process.
 
A new approach to testing known as "adaptive pathways" for experimental drugs against serious, hard-to-treat conditions s being pursued by Europe's drug licensing authority, the European Medicines Agency (EMA). Running from March 2014 to August 2016, it picked six drugs under development for a pilot scheme.
 
Gathering some of the evidence about its effectiveness and side effects in an everyday medical setting, known as the use of "real-world evidence" after bringing the launch of a promising drug forward on a provisional basis is one of the most contested methods advocated by the adaptive pathways approach.
 
While a standard treatment or placebo is given to a randomly assigned control group, with the results determining whether the medicine gets approved, under established randomized controlled trials (RCT), new drugs are given to some participants.
 
Whether it is getting the new treatment or not is not known to either group generally.
 
Using new medical sensors, smartphone apps and data processing tools, the new approach is to gather data from patients being treated. The group of patients eligible for the drug could be narrowed down or widened for permanent approval depending on the outcome of the real-world trial phase.
 
(Source:www.reuters.com)






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