NEWS OF THE W EEK
U.S. PROBE HURTS RANBAXY GENERICS: Questions about quality
spark concerns over buyout
RANBAXY
Ranbaxy Laboratories CEO Malvinder Singh (left) and Daiichi Sankyo CEO Takashi Shoda shook hands last month after signing the takeover deal.
I
NDIA’S RANBAXY Laboratories, one of the world’s
largest makers of generic drugs, faces investigation by the U.S. Justice Department into whether it violated FDA regulations by manufacturing adulterated and misbranded drugs. The allegations may disrupt Japanese drug firm Daiichi Sankyo’s plans, announced on June 11, to buy a majority stake in the company for $4.6 billion (C&EN, June 16, page 14). News of the investigation prompted a 12% drop in Ranbaxy’s stock price. DOJ is investigating because more than 25% of Ranbaxy’s generics are sold in the U.S. The firm also supplies generic versions of antiretroviral medicines for President George W. Bush’s
BROADER AGENDA FOR WEAPONS LABS RESEARCH: Half of labs’ work will
be non-weapons-related science
JACQUE LINE MCBRIDE/LL NL
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D’Agostino
OP OFFICIALS at the U.S. nuclear weapons
laboratories are planning a shift in research focus that will result in 50% of the labs’ work being unrelated to nuclear weapons. That reduces nuclearweapons-related work by 20 to 30% of current levels at most of the labs. The labs expect that the majority of the new research will come from projects within other parts of the federal government, explained Thomas P. D’Agostino, administrator of the National Nuclear Security Administration (NNSA). He was joined last week by the directors of Lawrence Livermore, Sandia, and Los Alamos National Laboratories, as well as the head of the Nevada Test Site, in briefing reporters in Washington, D.C., and in testifying before a House Armed Services subcommittee. The officials stressed what they called a new vision for NNSA. In a statement, they described NNSA as “moving from an outdated, Cold War-era nuclear weapons complex of today to a smaller, safer, more secure, and less expensive complex for the 21st century.” D’Agostino noted WWW.C E N- ONLI NE .ORG
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emergency program for AIDS relief, which provides low-cost HIV drugs to patients in developing countries. In its July 3 filing at the U.S. District Court for the District of Maryland, DOJ alleges that Ranbaxy submitted “false and fabricated” information to FDA about stability and bioequivalence and attempted to conceal violations of current Good Manufacturing Practices. According to the filing, “evidence suggests that Ranbaxy uses [active pharmaceutical ingredients] from unapproved sources, blends unapproved API with approved API, and uses less API in its drug than had been approved by the FDA” and that these conditions may lead to a drug that is “subpotent, superpotent, or adulterated.” In a public statement, Ranbaxy “strongly denies the allegations contained in the motion” and points out that no legal charges have been filed against the company. Ranbaxy says that it “has agreed to produce the specific documents sought by the motion.” Rich Salem, head of public affairs for Daiichi, tells C&EN that “we will follow this matter very closely as additional facts become public. Our acquisition plans are unchanged at this time.” The government allegations against Ranbaxy stem from a 2006 FDA investigation of its plant in Paonta Sahib, India, that resulted in a warning letter outlining significant violations of FDA regulations and specifying a hold on drugs originating from that facility.—MELODY VOITH
that the weapons responsibilities of the labs shrank along with the size of the nuclear weapons stockpile. Much of the research shift would expand securityrelated projects such as developing technologies to detect improvised explosive devices used in Iraq and Afghanistan, equipment to detect and disarm nuclear explosives, and technologies to counter bioterrorist devices, officials said. But lab directors also pointed to a greater emphasis on nonsecurity research such as science for nuclear power, climate change, biofuels, solar energy, energy storage, and carbon capture and sequestration. The shift comes at a time when the labs face continued budget reductions and have trimmed thousands of employees. It also comes as the labs are moving ahead on a long-term plan to modernize the overall weapons complex and reduce the workforce by 20 to 30%, as well as decrease the physical footprint of the weapons complex by one-third (C&EN, June 30, page 30). At the House hearing, Rep. Ellen O. Tauscher (DCalif.), a lab advocate and chair of the Armed Services Strategic Forces Subcommittee, urged a national debate on the future role of nuclear weapons before plunging ahead on modernization. Similar concerns have led to reductions in lab funding by congressional Appropriation Committees. Tauscher warned that Congress must set a path to ensure old buildings don’t crumble and staff aren’t laid off while the complex is modernized for demands of a post-Cold War world.—JEFF JOHNSON
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