The European Union’s top medicines regulator has called for a radical shake-up in drug safety with greater monitoring and independently funded research to identify problems with treatments already used by patients.
Thomas Lonngren, director general of the European Medicines Agency (EMEA) said that although the EMEA relied on a network of regulators and medical researchers across the EU’s 25 member states, “We do not have any intensive drug monitoring system.
“We have to find alternative methods to detect the safety of medicines.”
In an interview with the Financial Times, he also gave his support to the proposal that drug approvals should be conditional upon the completion of more detailed studies on potential health risks.
“From a safety viewpoint, we are keen to have a slower release [of new drugs].
“There is a conflict, because the company wants the biggest exposure immediately.”
Mr Lonngren’s comments will spark debate at a time of growing controversy on both sides of the Atlantic following health scares with authorised drugs including the SSRI class of anti-depressants and the anti-inflammatories, known as cox-2 inhibitors.
He said: “There is an urgent need to build up independent networks of intensive drug monitoring …If we had had better follow-up already in place, we might have discovered problems earlier.”
The EMEA does not yet have the power of the Food and Drug Administration (FDA), its US counterpart, but its authority is increasing and in November it will be responsible for giving conditional approval to drugs.
The detection of dangerous side-effects long after drugs have been introduced has led to renewed discussion about the need for greater efforts by regulators to identify problems with medicines once they have been authorised.
Mr Lonngren said since last year drugs companies had had to submit their own “risk management plans” on products as a condition for EMEA approval. But he argued the current system - under which the industry and doctors identify side effects - was inadequate.
The EMEA was drawing up its own enhanced risk-management plans for safety, he said. It was necessary to provide both private and public funding for additional research into the safety of medicines already in use, alongside the resources devoted by drug companies.
“Depending on the financial capacity, we have to set up independent studies, probably selecting a number of products that reach a great part of the population [with] chronic well-known diseases, such as cardiovascular problems and diabetes,” Mr Lonngren said.
“We need additional studies and intensive monitoring to discover serious side effects earlier.”
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