Policy Concentrates
Glyphosate renewed for five years in the EU Surprise decision by Germany swings vote in favor of reapproval The world’s top-selling herbicide, glyphosate, can stay on the market in the European Union for another five years after an unexpected vote in favor of the renewal by German agriculture minister Christian Schmidt. Germany abO OH stained from voting in all previous deO H liberations on glyphosate over the past P N HO few months. Schmidt took the decision OH into his own hands on Nov. 27, voting Glyphosate in favor of the five-year renewal, despite a lack of agreement within the German government. His decision was enough to swing the EU vote after months of talks ended in stalemate. The final vote by the European Commission’s Appeal Committee was 18 in favor, nine against, and one abstention. Farm groups and the pesticide industry are welcoming an end to the debate over glyphosate’s renewal in the EU, but they were hoping for a 15-year reauthorization. “We are pleased the substance has been reapproved, however not pleased that despite overwhelming scientific evidence it is only for a period of five years,” says Graeme Taylor, spokesperson for the pesticide industry group European Crop Protection Association. “This debate clearly sets many precedents for the future, and one of the most worrying is the way the movement against the substance has been driven by organizaThe controversial herbicide glyphosate tions relying on fear can continue being sprayed on crops in rather than science.” The French govthe EU for at least five years. ernment remains opposed to the five-year renewal for glyphosate. French President Emmanuel Macron expressed his disappointment with the vote, pledging on Twitter that France will ban the use of glyphosate “as soon as alternatives are found, and at the latest in three years.” He added, “#MakeOurPlanetGreatAgain.” Concerns about the safety of glyphosate, the active ingredient in Monsanto’s Roundup herbicide and many generic formulations, have been escalating since the World Health Organization’s cancer agency deemed the chemical a probable carcinogen in 2015. Regulators around the world, including the European Chemicals Agency and the European Food Safety Authority, dispute that classification, saying there is no evidence to link glyphosate to cancer or reproductive effects.—BRITT ERICKSON
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C&EN | CEN.ACS.ORG | DECEMBER 4, 2017
PHARMACEUTICALS
U.S. FDA wants more generic drugdevice combos U.S. Food & Drug Administration Commissioner Scott Gottlieb is continuing his push for cheaper drugs by making approvals of generics easier. FDA is committed to giving guidance on how companies can develop copycat products on complex drugs at least two years before the branded product’s patent expires, Gottlieb said on Nov. 28. He spoke at FDA’s Generic Drug Science Day in Silver Spring, Md. Complex formulations and active ingredients make some drugs difficult to copy. Drug-device combinations, such as inhalers or autoinjectors, are particularly tricky, since the device can be protected with new patents while the drug itself is decades old. For instance, Mylan’s EpiPen autoinjector contains epinephrine, a hormone first synthesized over 100 years ago. Mylan protested when other companies submitted generic drug applications for an epinephrine autoinjector, arguing that design changes confuse users. Adrenaclick is a cheaper alternative to the EpiPen. But because of design differences, it’s not considered a bona fide generic, meaning a pharmacist can’t substitute Adrenaclick when a doctor prescribes EpiPen. Gottlieb announced his intentions to help generic drug developers work around issues like this, saying approvals may allow for some design differences in a generic drug-device combination so long as the product’s clinical effect is the same. Gottlieb also pointed to a list of off-patent, off-exclusivity drugs with no approved generic that the FDA released this summer. By prioritizing any generic drug applications for drugs on that list, “we’ll be helping to reduce the financial incentive to play games with these drugs,” he said.—RYAN CROSS
BY THE NUMBERS
10,730
commercial chemicals were reported by companies under the Toxic Substances Control Act as being in use in the U.S. as of Nov. 10.
13,209
additional commercial chemicals were exempt from reporting but were also in use in the U.S. Source: U.S. Environmental Protection Agency
C R E D I T: S H UT T E RSTO CK
PESTICIDES
