Speakers’ comments at the Parenteral Drug Association’s Annual Meeting, held in Las Vegas on Apr. 20-24, 2009, reflected the crisis that pharmaceutical and biopharmaceutical industries face. Presenters alluded to a cloud of challenges (e.g., cost pressures, products that can be duplicated by competitors, and quality-control failures) that has been gathering for some time. Several speakers claimed that small- and large-molecule manufacturers must change now to survive in the short and long terms. But change how? Read more »

Janet Woodcock, director of the Center for Drug Evaluation and Research for the US Food and Drug Administration, spoke at the Drug, Chemical, and Associated Technologies Association (DCAT) annual dinner earlier this month, emphasizing the need of regulators and industry to meet the challenge of securing an increasingly complex global pharmaceutical supply chain. Her words were very well taken and show the recognition not only by FDA and other regulatory authorities, but also of pharmaceutical manufacturers and their suppliers, that the elongation of the global supply chain brings with it new responsibilities and ways of doing business. Read more »

In response to the changing economy, some companies are taking a different approach to supply-chain execution systems. This trend has businesses basing their strategies on reducing costs and streamlining operations rather than focusing on compliance with government or retailer guidelines. Read more »

The US Food and Drug Administration was buffeted by questions and criticism last year after the emergence of contaminated heparin. Lawmakers questioned whether the agency had investigated the problem thoroughly and been forthcoming about its findings. Several of FDA’s recent measures provide reassurance that it is attempting to protect American patients from contaminated drugs produced abroad. 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 »

As public and Congressional scrutiny of the pharmaceutical supply chain continues, a question that arises is whether e-pedigree will become a requirement for pharmaceutical ingredients. That debate may be inching toward the affirmative as Congress and federal agencies consider measures to improve the integrity of the pharmaceutical supply chain. Read more »

As we all know, Congressman Dingell has proposed the Food & Drug Administration Globalization Act, an important proposal that would enact some very important, far ranging and much needed changes to the FDA. While the Synthetic Organic Chemical Manufacturers Association (SOCMA) believes that increased oversight is a necessary step in correcting the issues of quality and eliminating counterfeiting in emerging markets, I thought I would discuss what companies should themselves be doing in response to these issues. Read more »

A recent Wall Street Journal blog post, “The Problem with Drug Provenance,” broached an interesting debate on whether the origin of ingredients in a drug should be listed as part of the drug’s product information. Read more »