New drug shortages cut in half as industry notifications increase
SILVER SPRING, Md. — The number of new drug shortages has been halved as early notifications from manufacturers of potential shortages have increased sixfold, the commissioner of the Food and Drug Administration wrote Thursday.
In a statement posted on the agency’s website to mark the six-month anniversary of an executive order by President Barack Obama designed to prevent shortages of critical drugs, FDA commissioner Margaret Hamburg wrote that the agency had prevented 128 shortages and saw 42 reports of new drug shortages, compared with 90 during the same period last year. Meanwhile, between the periods of January to October 2011 and November 2011 to April 2012, the average number of monthly notifications of potential shortages increased from 10 to 60.
"This data is a testament to how FDA exercises flexibility and discretion in much of our work on drug shortages and the importance of strong collaboration and constant communication with industry, health professionals and patients," Hamburg wrote.
Some highlights included the cancer drug methotrexate, supplies of which are currently meeting demand, with no further supply issues expected; and a response by the agency to a shortage of Johnson & Johnson’s cancer drug Doxil (liposomal doxorubicin) that allowed temporary importation of another brand of the drug, Sun Pharmaceutical Industries’ Lipodox, from India. When Hospira notified the FDA of a shortage of the surgical anesthesia drug propofol, the agency turned to another manufacturer and was able to increase supplies.
Still, some issues have remained, Hamburg wrote. These include the injectable cancer drug leucovorin, used to treat leukemia in children alongside methotrexate; the agency is working with Teva to produce additional shipments. Another drug, Lundbeck’s chemotherapy Mustargen (mechlorethamine hydrochloride) has experienced shortages as well, but the company is planning to make it available again in August.
"Drug shortages remain a serious, complex problem, and the agency remains extremely concerned about all current and potential drug shortages, not just those that I mentioned," Hamburg wrote. "Our efforts require a multifaceted approach involving industry, regulators, payers and others."
Washington state health officials declare whooping cough epidemic
OLYMPIA, Wash. — Washington state health officials have declared an emergency state action to slow the outbreak of whooping cough, also known as pertussis.
The state’s governor, Chris Gregoire, declared that emergency funds were made available Thursday to the state department of health to help curb the epidemic. According to disease investigators at the Washington department of health, 1,132 cases of whooping cough have been reported in the state through April 28, compared with 117 over the same time last year, with this year’s epidemic on pace to reach as many as 3,000 cases. There were 965 cases reported in 2011. No deaths have been reported.
In addition to the emergency funds, the Centers for Disease Control and Prevention has approved using federal funds designated for other immunizations to buy more than 27,000 doses of pertussis vaccine for adults who are uninsured or underinsured. Since the outbreak, such retailers and Rite Aid, Albertsons/Sav-On pharmacies and MinuteClinic, the retail clinic operator owned by CVS Caremark, have increased the availability of the Tdap vaccine against whooping cough at its locations.
“I’ve been following the epidemic closely and the continued increase in cases has me very concerned about the health of our residents," Gregoire said. "I’m especially concerned about the vulnerable babies in our communities that are too young to be fully immunized. These actions will help state and local health leaders get vaccine into people’s arms so we can stem the tide."
Mary Selecky, the state’s secretary of health, declared a whooping cough epidemic in Washington last month.
Watson appoints new VP global investor relations
PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals has appointed Lisa DeFrancesco as its VP global investor relations, the company said Friday.
Succeeding Patricia Eisenhaur, who will leave the company on June 1, DeFrancesco will report directly to chief communications officer Charles Mayr. She will be responsible for investor relations programs and serve as the company’s principal spokeswoman and point of contact with the analyst and investment community.
DeFrancesco began working for Watson in 2009 as manager of investor relations, receiving a promotion to director of investor relations in 2010. She previously worked for companies like Virgin Mobile USA, Realogy, Cendant and Horizon Blue Cross/Blue Shield.