Drug Firms Face Tighter Regulations

ENVIRONMENTAL TESTING

The regulation of chemicals has occupied Europe's regulatory spotlight for the past couple of years. But posing a more immediate challenge to the industry are plans being drawn up by regulators around the world requiring drugmakers to beef up environmental toxicology testing in addition to the human toxicology testing they already do.

That, at least, is the prediction of Steve Rumford, director for safety, health, and environmental science and technology at AstraZeneca's Brixham Environmental Laboratory, in southwest England. He made his prognosis late last month at the Society for Chemical Industry's SCIpharm conference.

Prior to the 1990s, Rumford pointed out, drug producers submitted nominal environmental data as part of their registration data. However, the increasing appearance since then of estrogen-related sex changes in fish in European waters, as well as trace levels of pharmaceuticals in U.S. and European surface waters, has caused regulators to reconsider requirements.

The European Medicines Agency, he said, is close to finalizing guidance for European Union countries that will focus on persistence of pharmaceuticals in the environment. Depending on how the guidance is written, Rumford explained, a company might have to run risk analyses on substances that subsequently fail in clinical trials.

Within the EU, the Swedish Association of the Pharmaceutical Industry already has begun including information on drug persistence, bioaccumulation, and toxicology (PBT) in its formulary. Where possible, physicians are urged not to prescribe drugs with bad PBT profiles, Rumford said, noting that regulations often spread from Sweden into the rest of Europe.

Canada, he said, is proposing an environmental approval system for pharmaceuticals that would be separate from its current regimen for human toxicology testing. "This will be very worrying if it goes through," Rumford observed. Canada's environmental authorities will be looking solely at a molecule's environmental profile and will not care that the molecule-under controlled conditions-might be a highly valuable pharmaceutical. Meanwhile, Japanese authorities "are seeking best practice from elsewhere. My guess is they will adapt the EU system."

Such moves may encourage U.S. environmental regulators to act on pharmaceuticals. For the present, however, action seems stymied by what appears to be a turf battle between the Food & Drug Administration and the Environmental Protection Agency, Rumford observed.

"In theory, the scientific process of environmental risk assessment should transcend national boundaries," he said. Even now, however, pharmaceutical industry regulators have different testing strategies. "And as more national agencies move in this direction, further regulatory diversity is likely," Rumford predicted.