FDA warns Mylan about alleged violations at Indian facility - C&EN

Apr 24, 2017 - “Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality ...
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▸ Congress returns as government shutdown looms Congress has until April 28 to pass a funding bill for fiscal 2017 to avoid a U.S. government shutdown. The deadline comes five days after Congress returned from a twoweek recess. Republicans, who control both houses of Congress, have said they do not want a government shutdown. But they will have to work with Democrats to fund the government, a task that has proved difficult in the past few years. The 2017 fiscal year started in October 2016. Since then, Congress has passed a series of temporary measures, called continuing resolutions, to keep the government running at fiscal 2016 levels because lawmakers could not come to an agreement. President Donald J. Trump proposed cuts to the fiscal 2017 budget to help pay for a wall along the U.S.-Mexico border, but it is unclear how those would fit into the negotiations. Some congressional leaders have indicated that they want a one-week extension to the current continuing resolution to give lawmakers time to make a deal. If a funding bill is not passed, the shutdown would start on the 100th day of Trump’s presidency.—ANDREA WIDENER

REGULATION

▸ Greater restriction of D4, D5 planned in EU The European Chemicals Agency (ECHA) is expanding its plan for restricting the use of two siloxanes in personal care and other products. The chemicals are octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5), both classified as very persistent and very bioaccumulative substances by the European Union. In recent years, ECHA has moved toward restricting the amount of D4 or D5 in wash-off personal care products such as shower gels, shaving foams, and shampoos to no more than 0.1% by weight. At the request of the European Commission, the EU’s administrative arm, ECHA is planning to enlarge this expected restriction to cover personal care products designed to be left on the body—such as creams—as well as consumer and professional products for washing and cleaning. Silicones Europe, a trade association repre-

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C&EN | CEN.ACS.ORG | APRIL 24, 2017

Power capacity expands, costs decline globally As clean technology costs continued to fall, the world added record levels of renewable energy capacity in 2016, the United Nations Environment Programme (UNEP) says in a new report. The global trends analysis finds that wind, solar, biomass and waste-to-energy, geothermal, small hydro, and marine sources added 138.5 gigawatts to global power capacity in 2016, up from 127.5 GW added the previous year. The added generating capacity roughly equals that of the world’s 16 largest existing power-producing facilities combined, according to the report. Total global investment in renewable energy last year—$241.6 billion—was about double that in fossil fuel generation but was 23% lower than in 2015. This lower investment was due largely to the decreasing cost of clean energy compared with that of traditional fuels, the report says. For example, the average dollar capital expenditure per Renewable energy generation megawatt for solar photovoltaics and capacity is growing rapidly around wind dropped by more than 10%, it the world, including in India. notes. “Ever-cheaper cleantech provides a real opportunity for investors to get more for less,” says Erik Solheim, executive director of UNEP.—GLENN HESS, special to C&EN

senting major manufacturers of silicones in Europe, supports ECHA’s plans for wash-off products. But it calls the move to restrict the two siloxanes in leave-on personal care products “premature.” The industry group is particularly concerned about D5, which it says has unique properties that contribute to product innovation.—CHERYL HOGUE

PHARMACEUTICALS

▸ FDA warns Mylan about alleged violations at Indian facility Generic drug maker Mylan has received a warning from FDA about alleged failure to control drug quality, significant violations

of manufacturing standards, and data integrity lapses at a facility in India. The facility produces antiretroviral therapies used to treat HIV infection. In an April 3 letter, the agency says its investigator, who inspected the Nashik factory in India’s western state of Maharashtra, allegedly found significant violations of current Good Manufacturing Practice regulations for finished pharmaceuticals. “Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” the letter says. The agency adds that failure to correct these violations may result in FDA refusing admission into the U.S. of items produced at the plant. In 2015, FDA expressed concerns over quality controls at three Mylan factories in Bengaluru, in south India.— K. V. VENKATASUBRAMANIAN,

special to C&EN

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