Trump signs FDA user fee legislation - C&EN Global Enterprise (ACS

President Donald J. Trump on Aug. 18 signed into law legislation (H.R. 2430) that will allow the U.S. Food & Drug Administration to continue collectin...
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POLLUTION

▸ At least 50 million in Pakistan at risk from arsenic contamination The first-ever hazard map of arsenic contamination in Pakistan’s groundwater shows 50 million–60 million people are at risk, according to a new study (Science Advances 2017, DOI: 10.1126/sciadv.1700935). Swiss, Chinese, and Pakistani researchers worked together to make the first largescale estimates based on a model that combined local geology and a set of 1,200 new groundwater quality samples, which had found contamination many times the World Health Organization’s recommended groundwater limits. This finding shows that more needs to be done to protect Pakistan’s people, including those in the major population centers of Lahore and Hyderabad. “This is an alarmingly high number, which demonstrates the urgent need to test all drinking water wells in the Indus Plain,” says lead author Joel E. Podgorski, a geophysicist at the Swiss Federal Institute of Aquatic Science & Technology. Some 150 million people worldwide were already estimated to be dealing with arsenic contamination of their groundwater. Even low concentrations of arsenic in water can cause symptoms ranging from skin discoloration to liver, heart, and kidney impairment or cancer.—ANDREA WIDENER

FDA will keep collecting user fees for safety reviews of new drugs under a new U.S. law.

PHARMACEUTICALS

Trump signs FDA user fee legislation President Donald J. Trump on Aug. 18 signed into law legislation (H.R. 2430) that will allow the U.S. Food & Drug Administration to continue collecting fees from industry to help pay for the agency’s safety and efficacy reviews of new drugs and medical devices. The legislation renews FDA’s authority to collect fees from fiscal 2018 through fiscal 2022. The agency’s current authority expires Sept. 30, the end of fiscal 2017. Although President Trump urged lawmakers to allow FDA to collect 100% of its total budget from industry paid fees, he did not get his wish. The new law instead authorizes FDA to collect about $1.4 billion, or 28% of its budget, in user fees from pharmaceutical companies and medical device manufacturers each year. It also aims to improve postmarket drug safety and gives generic drug manufacturers earlier access to FDA staff in the hope of getting more low-cost drugs to market. The measure passed the House of Representatives on July 12 and the Senate on Aug. 3.—BRITT ERICKSON

SYNTHETIC BIOLOGY

C R E D I T: S H UT T E RSTO CK

▸ Report provides map for assessing threats from biotechnology Most biotechnology applications are being pursued for legitimate purposes that could benefit human health, the environment, or the economy, but various reports have reached different conclusions about the potential for people to use such techniques to intentionally cause harm. To better understand how much of a threat biotechnology, especially synthetic biology, poses to human health, the U.S. Department of Defense commissioned the National Academies of Sciences, Engineering & Medicine to investigate potential security vulnerabilities related to manipulating biological functions, systems, or microorganisms. In an interim report released on Aug. 21, the committee provides a framework for examining possible security concerns related

to synthetic biology in the near, medium, and long terms. The framework also provides options for mitigating such concerns. The committee is accepting input on the framework until Sept. 5. Once it finalizes the framework, the committee plans to use it to assess the security threats posed by synthetic biology. Those threats and options to address them will be the subject of a future report.—BRITT ERICKSON

REPRODUCIBILITY

▸ Industry and academia can improve their partnerships Cultural differences between academic and industrial researchers are increasingly straining scientific collaborations, but those partnerships are essential to the health of the research enterprise. A commentary

in Science suggests ways to improve those relationships (2017, DOI: 10.1126/science. aan4906). The heart of the problem is a fear by industry that academic research is not reproducible, according to the multiauthor commentary, which is the result of an American Association for the Advancement of Science workshop. “Irreproducible research wastes time, money, and resources. Academic researchers, universities, and other institutions, industry, funding agencies, and [ journal] editors all have a role to play in raising research standards and creating an environment of trust between communities,” said the authors, who laid out suggestions for those players to help improve reproducibility. The commentary also outlines questions industrial and academic partners should ask when they form a partnership. They should decide up front what proprietary data can be shared and in what format, for example. They should also determine what will happen with the academic partner’s research and data after the collaboration ends.—ANDREA WIDENER AUGUST 28, 2017 | CEN.ACS.ORG | C&EN

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