PHARMACEUTICALS
▸ India waives clinical trials for drugs approved elsewhere
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India has waived a requirement that pharmaceutical companies conduct local clinical trials before drugs are approved for marketing in the country if those drugs have been approved in select other countries. The move will fast-track approvals and benefit patients, India’s government says. The New Drugs and Clinical Trials Rules, released last month, allow drugs to be approved in India without local clinical trials if they’re already approved in the US, UK, European Union, Japan, or Australia. Previously, it took 3–6 months to get a drug approved in India. The new rules will reduce that time to 1 month for drugs manufactured in India and 3 months for those made elsewhere. The Indian Society for Clinical Research welcomes the new approach to clinical trials, saying in a statement that the new rules “protect the rights, safety and well-being of patients, while ensuring a strong scientific base for the conduct of clinical trials.” But S. “Chinu” Srinivasan, co-convener of the All India Drug Action Network, an advocacy group focused on access to health care and medicines, says the rules will harm quality and safety. He is concerned that trials done in other countries will not have the ethnic diversity to ensure that drugs can be appropriately prescribed in India.—K. V.
VENKATASUBRAMANIAN, special to C&EN
POLLUTION
C R E D I T: S H UT T E RSTO CK
▸ Olin site tapped for expedited cleanup An Olin chemical manufacturing property in Wilmington, Massachusetts, that closed down in 1986 is on a fast track to get cleaned up and redeveloped. On April 2, the US Environmental Protection Agency added the property to its list of contaminated sites targeted for intense action so they can be redeveloped. The EPA says it hopes to expedite a plan to address contaminated soil and surface water and to remediate the worst groundwater pollution at the site. Wilmington closed municipal water supply wells near the facility in 2003 because of chemicals released from the site. The EPA is acting under an effort started in December 2017 to pare down the federal roster of sites polluted with hazardous waste that
CONSUMER SAFETY
US FDA seeks data on seizures that follow e-cigarette use The US Food and Drug Administration is warning consumers about reports of seizures in people, particularly children and young adults, who use e-cigarettes. From 2010 to early 2019, the FDA identified 35 reported cases of seizures after e-cigarette use, the agency announced on April 3. It is too early to tell if e-cigarette use is associated with an increased risk of seizures. “Many of the reports received to date lack enough information to identify a specific brand or sub-brand of e-cigarette. The reports also don’t provide enough detail to establish a clear pattern or cause for these incidents,” FDA commissioner Scott Gottlieb and principal deputy commissioner Amy Abernethy say in a statement. Nonetheless, the FDA wants consumers to be aware of potential safety concerns related to e-cigarette use. The agency is encouraging e-cigarette users to report past and future incidents of seizures and other adverse effects to the agency. The growing use of e-cigarettes by youth has prompted the FDA to reconsider allowing e-cigarettes to remain on the market while manufacturers prepare information to help the agency better understand the health risks of such products.—BRITT ERICKSON
are managed under the agency’s Superfund program. Some sites have remained on the Superfund National Priorities List for years or decades while final cleanup plans are drafted and implemented. The Olin site, which made specialty chemicals for the rubber and plastics industries, has been on that list since 2006.—CHERYL HOGUE
PESTICIDES
▸ US Interior official under scrutiny for blocking pesticide report Democrats in the US Congress are raising concerns about the Department of the Interior’s handling of a draft report on the impacts of two commonly used pesticides on endangered species. The report, which was prepared by the US Fish and Wildlife Service in 2017 but not publicly released, concluded that chlorpyrifos and malathion have harmful effects on hundreds of en-
dangered species, according to documents released through Freedom of Information Act requests from the New York Times and the Center for Biological Diversity, an environmental group. In a March 29 letter, Sen. Ron Wyden (D-OR) urged the Interior Department’s acting inspector general, Mary Kendall, to investigate whether Acting Secretary David Bernhardt, who in 2017 was deputy S secretary, stopped the report from beCl N O P O ing released at the O request of pesticide Cl Cl manufacturers Chlorpyrifos that disputed the report’s findings. The allegations come as the Senate considers confirming Bernhardt for the top spot at the Interior. “It’s disgusting that after pesticide companies asked for evidence of catastrophic harm to endangered species to be buried, Bernhardt gladly pulled out the shovels,” the Center for Biological Diversity’s director of government affairs, Brett Hartl, says in a statement.—BRITT ERICKSON APRIL 8, 2019 | CEN.ACS.ORG | C&EN
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