This week, the European Federation of Pharmaceutical Industries and
Associations (EFPIA) launched a two-month pilot project in Sweden designed to test a serialization and verification system in pharmacies that would fight counterfeit drugs. Read more »

The US Food and Drug Administration announced yesterday it is requiring a black box warning for two drugs used to aid smoking cessation, Chantix (varenicline, Pfizer, New York) and Zyban (bupropion, GlaxoSmithKline, London). Read more »

Yesterday, Thomas Lavery, 63, of Irvine, California, was sentenced to four years and four months of incarceration to be followed by three years of supervised release by the US District Court in Concord, New Hampshire, for his involvement in a prescription drug diversion case, according to a court release. Read more »

My colleague Erik Greb wrote an interesting blog post yesterday about new drug delivery technology reminiscent of childhood games. Games have changed dramatically, but the concept of using them to help educate applies today. Take for example, the problem of patient compliance. A video game called “Re-Mission” (HopeLab) is helping children and teens to “blast away” cancer cells (at least on screen). The point is that it empowers the young patient to take control, which unfortunately is not the case with many adult patients with cancer. Read more »

News reports about adulterated drugs seem to have been replaced by stories of contaminated food products. Cases of salmonella related to products that contain peanuts and pistachios are the latest examples. The US Food and Drug Administration has been blamed for failing to protect consumers, and commentators have cited outdated policies, inadequate staffing, and insufficient funds.

In February 2009, Rep. Rosa DeLauro (D-CT) proposed creating a separate Food Safety Administration to improve oversight of food products sold in the United States. But a recent FDA Warning Letter suggests that drawing a line between food and drug products might not be so simple. Read more »

Pharmaceutical Technology magazine presents part two of its vidcast program, recorded at INTERPHEX 2009. Click the links below to watch the vidcasts. (Click here to see day one of the vidcast program.) Read more »

Last week’s post discussed industry reactions to the delay of California’s ePedigree implementation deadline from 2011 to 2015 for pharmaceutical manufacturers. This week, PharmTech Talk caught up with Arvindh Balakrishnan, vice-president of the Life Sciences Industry Business Unit at Oracle, to get his thoughts on the California Board of Pharmacy’s decision. Read more »

Gov. Schwarzenegger recently signed a bill that extends California’s serialization and ePedigree implementation deadline to 2015 for manufacturers, 2016 for wholesalers, and 2017 for pharmacies. The postponement gives industry more time to prepare, but meanwhile, the supply chain continues to be vulnerable without the ability to track and trace prescription drugs. Read more »

One of the greatest challenges for the pharmaceutical industry, as well as the healthcare sector in general, is ensuring drug safety through proper patient compliance. A company’s adherence to strict development and manufacturing standards and quest for quality is pointless if in the end the patient does not understand the dosing regimen or the danger of not following correct administration. And the consequence of noncompliance is as deadly as ever. Read more »

The European Federation of Pharmaceutical Industries and Associations (EFPIA), the trade organization representing European pharmaceutical manufacturers, is advocating a comprehensive strategy to address counterfeiting of drugs. Among its recommendations is a proposal to extend good manufacturing practices (GMPs) to include good distribution practices (GDPs). Read more »