The European Medicines Evaluation Agency (EMEA) has promised to get tough with pharma companies if they fail to follow its
rules for reporting product side effects. It may resort to naming and shaming those that do not comply and could even prosecute
As several high-profile withdrawals have shown, no matter how carefully companies carry out and analyze Phase III trials,
those studies are not extensive enough to pick up all potential serious adverse reactions that more widespread use may reveal.
That came into sharp focus recently with Bayer's withdrawal of Baycol (cerivastatin) after several deaths were linked to use
of the product. More recently, Abbott's anti-obesity drug Meridia (sibutramine) was removed from the market in Italy following
a number of adverse events.
During his first year in office, EMEA head Thomas Lonngren has emphasized the importance of pharmacovigilance. As a result,
the agency recently issued a position paper on compliance with pharmacovigilance regulatory obligations, following extensive
consultation with all interested parties, from national regulatory agencies to pharma companies. Key points include the need
for companies to:
- act quickly at the first sign of potential trouble, both to ensure public safety and to minimize consumer fears
- have at least one person responsible for pharmacovigilance at all times
- collate pharmacovigilance data and make them accessible.
- continuously monitor the safety profile of medicinal products and to notify authorities and health professionals within 15
days of any changes to a product's risks or benefits.
The agency has threatened to get tough with companies it believes are not taking their responsibilities as seriously as they
EMEA also introduced an electronic reporting system in December 2001 to facilitate quicker and easier reporting and monitoring
of adverse effects. Now pharma companies and national authorities are undertaking the difficult process of entering all relevant
data on the system.
An EMEA spokesman says it will be a couple of years yet before the system is fully operational. But, ultimately, it will make
the reporting of side-effect problems easier. Because of the limited populations involved in prelaunch trials, it is impossible
to pick up every problem before a drug hits the market. So pharma companies must be diligent about minimizing the impact of
adverse drug reactions. If the threat of being named and shamed is what it takes to make that happen, EMEA says, then so be