400 generic drugs in the hot seat

400 generic drugs in the hot seat
400 generic drugs in the hot seat

The European Union has asked its members to withdraw several hundred generic drugs from the market, ruling that their effectiveness had been poorly evaluated. National health agencies have until Monday to decide.

At the end of May, the European Commission asked EU states to suspend the authorization of around 400 generic medicines, giving them a deadline of one month. It will expire on Monday.

Generics are drugs whose base molecule, the active substance, has fallen into the public domain. Their manufacture is therefore no longer reserved for the owner of their patent.

Their authorization follows much less strict rules than a new treatment. The manufacturer of generics, such as the Israeli Teva or the French Biogaran, must not prove again their clinical effectiveness or their absence of danger.

It just needs to demonstrate in vitro that the generic drug releases the same quantity of active substance as its model. This is ‘bioequivalence’ and this is the problem here.

Missing data

Generic manufacturers often do not do these tests themselves. They use subcontractors, called ‘contract research organizations’, CROs.

However, the European health authority, the European Medicine Agency (EMA), discovered that one of these groups, the Indian Synapse Labs, was not carrying out these tests with the required rigor.

‘For the majority of treatments tested by Synapse Labs, (…) data are missing or insufficient to prove bioequivalence,’ the EMA summarized in March.

The treatments concerned

The 400 drugs targeted cover a wide range: anticancer drugs, particularly against leukemia and breast cancer, antidiabetics, therapy against HIV infection, antiepileptics, treatment of schizophrenia, etc.

As many generic producers use Synapse’s services, the concern is not limited to one generic manufacturer but concerns all the main players in the sector.

EU countries are unequally affected, depending on the treatments approved there. France, for example, is quite affected with 72 problematic drugs.

The risk for patients

There is no immediate danger and health authorities, like patient associations, are careful not to create panic.

‘There is no manufacturing defect,’ Yann Mazens, one of the managers of France Assos Santé, the main French federation of patient associations, insisted to AFP.

But ‘we are faced with products that potentially do not have the same effectiveness because the studies have not met the standards,’ he said.

And if this lesser effectiveness is not proven as it stands, it remains a possibility and the patients concerned therefore run the risk of being less well treated, sometimes for serious and deadly pathologies.

Likely delay

National authorities are certainly not going to withdraw all these drugs from the market on Monday.

First, because some manufacturers of these generics have already repeated tests and proven the bioequivalence of treatments on the list.

Then, and above all, the European Commission left wide room for maneuver to States not to immediately withdraw irreplaceable treatments for patients.

‘These critical drugs are those which would have large market shares or would have no therapeutic alternative,’ underlined the French medicines agency, ANSM, interviewed by AFP.

In this case, Brussels gives States up to two years to finally withdraw a treatment, in the event that conclusive data has still not been provided by the manufacturer.

The ANSM, which will make a decision on Monday but will not communicate publicly immediately, is refusing for the moment to give any order of magnitude on the number of immediate withdrawals.

Likewise, in Germany, another country concerned for numerous treatment references, the Federal Institute for Medicines and Medical Devices refrained from commenting to AFP.

/ATS

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