Generic drug makers are asking the Food and Drug Administration for help in solving facility and production-line problems that are causing drug shortages.
There are 111 drugs that are in shortage in the U.S., including 49 generics, FDA Commissioner Margaret Hamburg said in a keynote speech.
Industry officials attending the recent annual meeting of the Generic Pharmaceutical Association in Orlando, Fla., said they need more communication from the FDA to remedy the situation.
Regulators who cite company violations should work with drug makers to address problems immediately, rather than waiting months and causing long disruptions to the production process, association Chief Executive Ralph Neas told trade publication FDA Week.
“There should be communication and coordination from the beginning, because you don’t want a situation where all of a sudden FDA is shutting down facilities or plants precipitously without working with the manufacturers,” Neas said.
Orange County companies with membership in the Washington, D.C.-based Generic Pharmaceutical Association include Teva Pharmaceutical Industries Ltd., an Israeli company whose U.S. unit, Teva Americas, has some 500 employees in Irvine; Anchen Pharmaceuticals Inc., located in Irvine and a unit of New Jersey-based Par Pharmaceutical Cos.; and Watson Pharmaceuticals Inc., a New Jersey company founded by Anaheim Hills resident Allen Chao.
Hamburg warned that quality issues affecting drug shortages could damage the generic industry’s reputation and urged drug makers to step up efforts to ensure quality, according to FDA week.
Neas afterward told the publication that he had two 90-minute meetings with Hamburg to discuss drug safety.
The association is pushing a plan it calls an “accelerated recovery initiative” to stem shortage. But officials said the initiative won’t solve drug-shortage issues without better regulatory communication about facility shutdowns and other enforcement brought on as a result of manufacturing issues.
Accelerated recovery—under review by the Federal Trade Commission—would allow competing companies to share information about sales and suppliers. Sharing such information is appropriate in view of the drug shortage situation, William Marth, Teva Americas’ chief executive, told FDA Week.
“It’s all about the appropriateness of when you do share information and when you don’t, and that’s why the third-party concept makes so much sense,” Marth said.
UC Irvine Study
Blocking a natural, marijuana-like chemical in the brains of mice boosted their fat-burning ability, according to a new study by researchers from the University of California, Irvine, Yale University and Marche Polytechnic University in Ancona, Italy.
Daniele Piomelli, a UC Irvine pharmacology professor, and colleagues engineered neurons in the forebrains of laboratory mice to limit production of an endocannabinoid compound called 2-AG. All mammals’ brains contain 2-AG, which the researchers believe helps control activity of forebrain neural circuits involved in energy dissipation.
Endocannabinoids are created naturally in the body and share a similar chemical structure with THC, which is the primary psychoactive component of marijuana.
The study showed that the modified mice ate more and moved less than typical mice but didn’t gain weight, even when fed a high-fat diet. They also didn’t develop signs of metabolic syndrome, which is a combination of obesity and high blood pressure that increases the risk of heart disease and diabetes.
But Piomelli said in a release that it wasn’t likely that a drug limiting 2-AG levels would be available for weight loss, because the mice were bred with brain cells limiting the compound’s production, something that can’t be done with humans.
“To produce the desired effects, we would need to create a drug that blocks 2-AG production in the brain, something we’re not yet able to do. So don’t cancel that gym membership just yet,” Piomelli said.
Study findings appear in the March issue of industry journal Cell Metabolism. The National Institute on Drug Abuse supported the study.
Purchasing Contract
Nihon Kohden America Inc., a maker of patient monitors out of Foothill Ranch, won a three-year physiological monitoring group purchasing contract with the Charlotte, N.C.-based Premier Healthcare Alliance.
The contract was effective March 1.
Device giants General Electric Co. of Stamford, Conn., and Netherlands-based Royal Philips Electronics NV were also included in the deal.
Nihon Kohden America is a wholly owned subsidiary of Japan-based Nihon Kohden Corp.
Bits and Pieces
Talbert Medical Group, a Costa Mesa-based division of HealthCare Partners, recently opened an office on Newport Avenue in Tustin near the Santa Ana (I-5) and Costa Mesa (55) freeways. … oBand Inc., a Los Angeles-based outpatient surgical center chain, said its Tustin office is using the da Vinci robotic-assisted surgical device.
