Margaret Hamburg, commissioner of the US Food and Drug Administration, spoke at the United States Pharmacopeial (USP) Convention last week and put forth her underlying philosophy as commissoner: building collaborative models to address ongoing challenges to secure public health, which includes oversight of pharmaceutical products. Part of that effort involves building greater cooperation with USP in working on the development and modernization of USP monographs as well as strategies for combating adulteration of products and ensuring product quality. Read more »

Spring is in the air, and it’s time for a trip to the Javits Center for the annual INTERPHEX conference and exhibition. The editors of Pharmaceutical Technology and BioPharm International have arranged a series of interviews during the conference. We’ll be talking to pharmaceutical professionals, information-technology experts, and regulators about current challenges in manufacturing and about what the future might bring. Read more »

Parallel trade in the EU: there are arguments for it and arguments against it, but the latest reports from the UK suggest that the trade is having a significantly negative impact on patients and the supply of medicines. Read more »

The international pharmaceutical supply-chain consortium Rx-360 held a launch meeting in Europe last week with more than 135 industry and regulatory representatives in attendance. Read more »

Technology is not the answer, at least not for tackling pharmaceutical counterfeiting. Instead, increasing criminal sanctions and encouraging relevant parties to work with “certified and reliable partners” are the real solutions. Read more »

Last week, Alexis Pellek of Pharmaceutical Technology wrote about a pilot project launched by the European Federation of Pharmaceutical Industries and Associations to test a new system designed to battle counterfeit drugs (See the blog post.) The system involved using DataMatrix 2D barcodes, which enable pharmacists to test the legitimacy of each packet.

We spoke with Mark Beauchamp, European Marketing Manager of Citizens Systems Europe, a firm that specializes in barcode technology, to better understand how barcoding can help the pharmaceutical industry to clamp down on counterfeit drugs. Read more »

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 »

IPEC-Americas Chair Janeen Skutnik continued the call for more standards and regulation for the pharmaceutical excipients industry at yesterday’s IPEC Regulatory Conference afternoon session. “We’re not the Rodney Dangerfields of industry anymore,” she said, playing on the fact that many feel excipients are somehow a “lesser” part of the pharma industry because they’re “inactive” drug ingredients. “We need to work with Congress and regulators to put in place the right standards,” she said. Read more »

“We want to be regulated.” That seems to be the theme thus far at the IPEC Regulatory Conference, taking place today and tomorrow in Washington, DC. The morning session opened with IPEC Chair Janeen Skutnik talking about how busy the past year has been for the excipient industry and for IPEC itself. With work being done on pedigrees, functionality, GMPS, and GDPS, excipients are taking on all sorts of new lives. Read more »

Pharmaceutical brands face an increased threat online, according to a new report by the brand-protection firm MarkMonitor. The study, Brandjacking Index: Summer 2009, focused on six leading drug brands and examined these key areas of pharmaceutical brand abuse online: illicit pharmacies, listings on B2B exchange sites, and cybersquatting, or the abuse of a trademark within a domain name. Read more »