A Drug Watchdog To Rival The FDA

Europe's agency will soon have new powers. Will it take the lead on safety?

Since its creation a decade ago, the European Medicines Agency has played the weak sister to its older, more powerful, and better-funded, counterpart, the U.S. Food & Drug Administration. But that may soon change. New legislation that goes into effect in November will give the London-based agency expanded powers to monitor and enforce drug safety. In some critical areas, the European regulator's authority will exceed even that of the FDA.

The timing couldn't be better. Drug regulators worldwide suddenly find themselves under a spotlight, following a spate of drug safety scares. The most prominent case involves Merck & Co.'s (MRK ) painkiller Vioxx, which the company pulled from the market in September after it was discovered that those taking the drug were at higher risk for heart attacks and strokes.

Although the FDA posted a safety warning on its Web site on Sept. 30, immediately following Vioxx' withdrawal, it took the European regulator six more days to do the same. The agency, which was previously known as the European Medicines Evaluation Agency and still goes by the acronym EMEA, had concerns about the safety of Cox-2 inhibitors such as Vioxx as early as 2003. But after an initial safety review, it went on to approve it and four other Cox-2 drugs, including Pfizer Inc.'s (PFE ) Bextra, a drug that a recent study found tripled heart attack and stroke risk in heart-bypass patients. "The Vioxx debacle shows the current system is not working," says Jeremy Smith, campaigns coordinator for Health Action International, a public advocacy group based in Amsterdam. "New medicines should only go on the market once they are proven to be safe."


Now, after years of marching in lockstep with the FDA, the EMEA has a shot at taking a leadership role in improving drug safety and restoring badly shaken consumer trust. By yearend, the London regulators will boast powers that go beyond those of their peers in Washington. Under the new law, the EMEA can demand additional studies from pharmaceutical companies if concerns about a drug's safety or effectiveness emerge after it is on the market. Companies that don't comply can get hit with hefty penalties of up to 10% of a company's total annual revenues. "This is an important new power the FDA does not possess, and one that would require a change in [U.S.] law," says Linda Horton, a former senior FDA official who is now a partner at the Brussels law firm Hogan & Hartson.

Drugmakers, take note: Unlike its U.S. counterpart, the EMEA will also have the power to yank a medicine from the market not only if it proves harmful but also if clinical evidence indicates the drug is less effective than previously thought. "In the past, there was little possibility from a legal standpoint that the agency could use efficacy as a criterion to remove a drug from the market," notes Thomas Lönngren, the Swede who runs the agency.

In other areas, the Europeans are playing catch-up. For instance, the new laws will allow the EMEA to grant fast-track review and conditional approval for potentially lifesaving drugs, a power the FDA already has. In exchange, the drugmaker will agree to conduct detailed follow-up studies once the product is on the market. If companies fail to do so, the European regulator will be able to impose penalties -- which the FDA cannot do.

One question that still lingers is whether the European agency will exercise its new powers to take on Big Pharma. The agency derives 70% of its $144 million annual budget from fees paid by the pharmaceutical makers for drug approval applications -- a fact that prompts critics to question its ability to act independently. Industry fees provide 44% of the $590 million the FDA spends on its two centers that review drugs. "The amount of industry funding for the European Medicines Agency has steadily increased, making it harder for them to resist industry pressure," says Dr. Christophe Kopp of the Paris-based drug journal Prescrire. Lönngren dismisses the complaint, noting that this "is the normal model for financing regulatory agencies worldwide." But, he admits, "we need to follow up and monitor safety issues much better than we are doing." It's up to the EMEA to make the most of its new powers.

By Kerry Capell in London, with John Carey in Washington

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