When most of us look at taking a new medicine we tend to think it will make us better. Some of us may think about possible side effects but few of us expect the medicines we take to actually be dangerous. Recently, the public and policymakers have become more aware of the issue of counterfeit medicines — especially as patients increasingly learn about how to shop safely online for pharmaceuticals. But scant attention has been paid to a safety issue that is also important to patients — the problem of substandard medicines. Read more »

The Organization for Professionals in Regulatory Affairs (TOPRA) is a non-profit, non-political organization that seeks to advance the status of the regulatory profession through education and the provision of information to its members. Its members are drawn from industry, regulatory agencies and consultancies from over 40 countries. Pharm. Exec. Europe (PEE) spoke to TOPRA’s president-elect, Dr Zubair Hussain, head of regulatory affairs for Pfizer UK and Ireland, about what he sees as pharma’s key regulatory challenges for 2010 and beyond. 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 »

The US Agency for International Development (USAID) and the US Pharmacopeial Convention (USP) recently announced a new program designed to fight the growing problem of substandard and counterfeit drugs in developing countries. 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 »

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 »

At a joint session of the PharmTech Conference and the 4^th Annual Manufacturing Execution System in Life-Sciences Congress earlier this month, during my opening remarks, I discussed FDA’s proposed budget increase of $166 million and 346 FTEs toward Medical Product Supply Chain Safety and Security Oversight. The globalization of manufacturing and supply of medical products has created unique and demanding challenges for industry and FDA alike. Yet, according to a recent Axendia study on QMS trends in Life-Sciences, only 34% of respondents reported view global quality data in real time. Read more »

Like the recent report on Microsoft Bing’s sponsored ads for online pharmacies, a new report released this week by Internet-pharmacy verification organization LegitScript and antispam firm KnujOn focuses on the legitimacy of online pharmacies advertising in sponsored links on Yahoo.com. Read more »

A new report shows that sponsored links on Bing, Microsoft’s new search engine, led to illegal Internet pharmacies. Of the advertisements studied, 89.7% led to what the report calls “rogue” pharmacies that break federal and state laws, as well as Microsoft’s advertising policies in several ways, most notably by not requiring prescriptions for prescription drugs and for selling counterfeits. Read more »