NEWS OF THE WEEK DRUG
REGULATION
EU TO AMEND NEW DRUG RULES
lectual property protection a drug firm now receives, depending on which member state reviews and approves a new drug application. However, a spokesman for the European Federation of Phar-
Centralized review process to speed market approvals for pharmaceuticals
E
UROPEAN U N I O N HEALTH
ministers gave preliminary approval to centralized drug review regulations that would make new pharmaceutical approvals possible in under a year. The new rules, which the European Parliament is expected to approve by December, is a step toward the creation of a single EU drug agency with broad powers similar to the U.S. FDA. Erkki Liikanen, the European commissioner for enterprise, said the agreement takes "an important step toward ensuring that Europe gets a more robust ... regulatory framework for pharmaceuticals." Under the rules, the European
Medicines Evaluation Agency's (EMEA) authority would expand to cover new drug applications for cancer, AIDS, neurodegenerative diseases, and diabetes. Other types of drugs could continue to gain approval through the London-based E M E A or member state health agencies. Up to now, only biotechnology drugs had to be approved through EMEA, established in 1995. Drugmakers whose medicines must follow the centralized review process would have exclusive rights to data generated on new drugs for 10 years plus one additional year for an alternative use. That is an improvement over the six to 10 years of EU intel-
TOXICOLOGY
EVALUATING PESTICIDES EPA must consider human test data
A
FEDERAL APPEALS COURT
has struck down EPA's decision to refuse all data from human tests of pesticides conducted by third parties. However, the judicial panel left EPA an opportunity to reinstitute the ban by proposing it as a formal rule. It also said that any studies with humans must be conducted according to the highest ethical standards and must follow the Common Rule—federal policy for protection ofhuman subjects. The court "confirmed {EPA's] authority to reject industry human tests that do not satisfy strict HTTP://WWW.CEN-ONLINE.ORG
regulations and the highest ethical standards," says Erik D. Olson, a senior attorney at the Natural Resources Defense Council. Under these criteria, EPA would have to reject all human tests conducted so far, he says. However, American Chemistry Council (ACC) counsel Jamie Conrad contends that all the existing studies of pesticides using humans followed the Common Rule. In the late 1990s, EPAreevaluated its practice ofrelying on data from human studies and began considering such data only on a
maceutical Industries & Associations said it was "illogical" to provide less protection to drugs that did not have to follow the centralized approval procedures. A provision in the new rules would allow generic drugmakers access to drug data in the eighth year following approval so they could be ready with cheaper versions as soon as the 10 years of protection expired. —MARC REISCH
case-by-case basis. In December 2001, the agency announced that it would not consider data from any human studies until the National Academy of Sciences reviewed the ethical issues involved. Next, industry groups CropLife America and ACC asked the U.S. Court of Appeals for the District of Columbia Circuit to intervene. In their complaint, they said the rejection of human data by EPAwas unlawful because it constituted a regulation issued without a notice of proposed rule-making. They also said EPAs decision violated two federal laws requiring the agency to consider "all relevant data." In response, EPA contended the ban was not a rule but a "policy statement."-BETTE HILEMAN
LEGISLATION More European labs such as this one will be regulated under a single EU drug agency by year's end.
APPLICATION New sprayers use less pesticide.
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