Regulatory Roundup: FDA Issues Public Alert on Stolen Insulin, More...

September 17, 2009
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, FDA's enforcement of its rules for response times for Form 483s went into effect this week, more...

The US Food and Drug Administration issued a public alert regarding recently stolen vials of long-acting insulin (Levemir, Novo Nordisk) that may still be on the market. FDA first alerted the public to the theft in June 2009. “Evidence gathered to date suggests that the stolen insulin was not stored and handled properly and may be dangerous for people to use,” according to the alert. In related news, Dey, a subsidiary of Mylan, issued an advisory regarding the theft of two types of its respiratory medications, Ipratropium Bromide Inhalation Solution, 0.02%, and Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials. The lots were on a tractor-trailer that was stolen in Florida. Although some lots were successfully transferred to the marketplace, Dey is recalling all related lots of these medications to be sure the public is safe.

FDA’s new enforcement plan went into effect this week on Sept. 15, 2009. The agency announced the program, aimed at improving public health by taking timely action, in August. Companies that fail to respond to a Form 483 within 15 business days are subject to receiving an FDA Warning Letter. (see back story, Warning Letter Enforcement Begins in September)

On Oct. 24–29, in St. Louis, Missouri, the Steering Committee and Expert Working Groups of the International Conference on Harmonization (ICH) will meet. In preparation for the event, FDA is holding a public meeting on Oct. 14 in Rockville, Maryland, to provide information and receive comments on the ICH efforts, according to an FDA notice. The ICH Global Cooperation Group will also meet in Missouri. Individuals interested in the public meeting must register with Mary Morrison at Mary.Morrison@fda.hhs.gov or by fax at 301.827.0003.

On Sept. 14, 2009, the Innovative Medicines Initiative (IMI), a public–private partnership between the European Commission and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA), announced the topics of research of its second call for proposals. IMI was launched in 2007 to “support more efficient discovery and development of better medicines for patients by removing research bottlenecks in the current drug development process,” according to an IMI release. The IMI budget for 2008–2017 is €2 billion ($2.9 billion), with half coming from the European Community and half from industry. In April 2008, IMI received 134 proposals, 15 of which were selected to receive €246 million (approximately $359 million). The funding available for the second proposal call is €156.3 million ($227.9 million), with €76.8 million ($112 million) to be provided by the European Commission and €79.5 million ($116 million) to be provided by EFPIA member companies.