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 »

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 »

Following up on last week’s post, it appears that the H1N1 flu vaccine is effective in older children, ages 10 to 17, based on preliminary results of an ongoing trial. This week, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced that early results of clinical studies of the vaccine “look promising.” Read more »

The US Food and Drug Administration approved on Tuesday four H1N1 flu vaccines that demonstrated in clinical studies that a single dose produced a strong immune response in healthy adults after 8–10 days. Based on the manufacturers’ production schedules, things seem to be on track for vaccines to be available in four weeks.

But clinical trials of the vaccine are still underway on pregnant women and children, two groups that the Centers for Disease Control and Prevention (CDC) says are especially vulnerable to the H1N1 flu. Read more »

Last month, US Food and Drug Administration Commissioner Margaret Hamburg announced the agency’s six-point plan for tougher enforcement of its policies and regulations as means of protecting public health. The plan, which includes actions like setting postinspection deadlines, speeding the Warning Letter process, and working more closely with FDA’s regulatory partners, was designed to “to prevent harm to the American people,” as Hamburg said in an FDA release. 

The agency has been actively involved in several recent cases involving instances of illegal importation and sales, drug diversion, and misbranding of drug products. 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 »

A new report released by OpSec Security, a provider of anticounterfeiting and brand protection services, found an increased amount of illicit behavior in sales of bulk pharmaceuticals and prescription drugs over the Internet. Read more »

President Obama plans to nominate geneticist Francis S. Collins director of the National Institutes of Health (NIH), according to a White House statement released Wednesday. Collins led the Human Genome Project and served as director of the National Human Genome Research Institute at the National Institutes of Health from 1993-2008. Read more »