Generic drug approvals in U.S. set record in 2015 - C&EN Global

An annual report issued by the Office of Generic Drugs shows that 580 generic drugs were cleared for marketing and another 148 were tentatively approv...
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Policy Concentrates RESEARCH FUNDING PESTICIDES

▸ Sides drawn over EPA proposal to ban chlorpyrifos EPA’s plan to halt all agricultural uses of chlorpyrifos, a common organophosphate insecticide, to protect children from neurodevelopmental risks is drawing mixed reactions. The pesticide industry, farm groups, and USDA are criticizing the proposal because it relies on a single human

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U.S. federal R&D support rose in 2014 Federal agencies committed in 2014 to fund $62.9 billion in research, up 6% from $59.2 billion in 2013, according to data released last month by NSF. Physical sciences, including chemistry, received $6.5 billion of that funding. Here is how physical sciences support broke down by agency in 2014.—ANDREA

WIDENER Health & Human Servicesa 2% Department of Agriculture 2% Department of Defense 12%

Department of Energy 42%

National Science Foundation 13%

National Aeronautics & Space Administration 22%

Chlorpyrifos

epidemiological study. Environmental groups and some external EPA advisers, however, claim that current hazard assessment methods, which rely on measuring inhibition of the enzyme acetylcholinesterase in laboratory animals, fail to protect children. Agency advisers are urging EPA to consider all relevant data, including other epidemiology studies and animal toxicity data, to strengthen its assessment. Late last year, EPA proposed to ban all uses of chlorpyrifos on food, saying the agency cannot ensure that combined exposure to chlorpyrifos from food and drinking water is safe. If the agency finalizes the proposal, it will mark the first EPA ban of a pesticide on the basis of human epidemiology data rather than results of tests on animals.—

BRITT ERICKSON

PHARMACEUTICALS

▸ Generic drug approvals in U.S. set record in 2015 A record number of generic drugs—more than 700—were awarded either final or tentative approval in 2015, FDA says in a recent report. An annual report issued by the Office of Generic Drugs shows that 580 generic drugs were cleared for marketing and another 148 were tentatively approved during the year. FDA issues a tentative approval letter to a generic product applicant when the patents on

Other 7%

Federal obligations for physical sciences in 2014 = $6.5 billion a Includes the National Institutes of Health. Source: NSF

the original brand-name medicine have not yet expired. A product that has tentative approval cannot be sold in the U.S. The report indicates that FDA rejected nearly 1,300 generic drug applications in 2015 and directed the manufacturers to fix problems. The agency, meanwhile, has essentially eliminated a backlog that once included more than 1,100 applications and is able to inform companies within about 40 days whether their application is sufficient for a full FDA review. In addition, the report touts FDA’s science initiatives to help the generics industry develop products that currently exist only in brand-name form. These include drugs that are inhaled or applied topically and are difficult to reproduce.—GLENN HESS,

special to C&EN

SUSTAINABILITY

▸ Group raises stink about a fragrance An environmental group last week called on U.S. consumer product makers to halt use of a synthetic musk fragrance sold under the trade name Galaxolide. Women’s Voices for the Earth says published studies show 1,3,4,6,7,8-hexa-

hydro-4,6,6,7,8,8-hexamethylcyclopenta-γ-2-benzopyran (HHCB), which is used in laundry products, air fresheners, personal care products, and perfumes, is increasingly found in the Great Lakes. The group pointed to an assessment it com-

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HHCB missioned of HHCB that concluded the chemical is persistent, accumulates in the environment, and is toxic to aquatic life. The assessment was done with GreenScreen for Safer Chemicals, a proprietary tool used to examine a compound’s hazards and compare it against alternative substances. SC Johnson, a company the activists are targeting for using HHCB, has cried foul. The company says the chemical “is present at very low concentrations that are hundreds to thousands of times lower than levels deemed safe by worldwide regulatory agencies.” EPA last year announced it could not identify any significant risks associated with HHCB. Similarly, the European Union has determined that there is no need for regulatory action on the substance.—CHERYL

HOGUE MAY 2, 2016 | CEN.ACS.ORG | C&EN

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