Pharmaceutical manufacturer GlaxoSmithKline is warning consumers that some bottles of its over-the-counter weight loss drug Alli (orlistat capsules) have "tampered with" in at least seven US states. News of the tampering was announced by GSK in a 26 March 2014 press release, in which the company said it was working with the US Food and Drug Administration (FDA) to determine what had happened and the extent of the problem. GSK said the tampered products had packaging tha...

The US Food and Drug Administration (FDA) is stepping up its attempts to go after online pharmacies peddling counterfeit and fake medicines to US consumers, announcing that it is embedding one of its agents with EU's law enforcement agency, Europol. Background: Counterfeiting US regulators have been seeing an influx of counterfeit products in recent years, testing both the limits of the security of the pharmaceutical supply chain and the ability of regulators to stop pr...

An upcoming advisory committee of the US Food and Drug Administration (FDA) is set to discuss how the agency can engage in best practices for communicating with health care professionals and others about the risks of counterfeit and unapproved drugs. Background US regulators have been seeing an influx of counterfeit products in recent years, testing both the limits of the security of the pharmaceutical supply chain and the ability of regulators to stop products before t...

A new tool unveiled Thursday by US regulators on the eve of world malaria day promises to assist global public health officials with the detection and removal of counterfeit anti-malarial drugs, the likes of which now contribute to a budding public health crisis. Basics: The CD-3 The device, known as the Counterfeit Detection Device v.3 (CD-3), was developed by the US Food and Drug Administration (FDA) with support from the Skoll Global Threats Fund, the US Pharmacopeia...

The 2012 passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) was remarkable for both the number of reform provisions contained within it and the overwhelming support it received in the US Congress. But that support was not earned without some hard negotiating, and several prominent but controversial provisions were dropped from the final iterations of the bill. Now some of the industry's most prominent voices are taking to the Washington press...

What happens when your local regulatory agency isn't known as being reliable or capable at overseeing the safety and quality of products in your country? In at least one country, consumers could soon have a private-sector solution to improve their ability to ensure their medicines are of sufficient quality and identity. That initiative, run by the Partnership for Safe Medicines India Initiative (PSMII), is a side project of the Partnership for Safe Medicines-a coalition ...

A new report just published by the US Institute of Medicine (IOM) and sponsored by the US Food and Drug Administration (FDA) finds that global regulators and regulatory systems need to do more to combat the rising tide of falsified and substandard medicines. Background Though the two terms-falsified and substandard-are often used interchangeably, there is an appreciable difference. A falsified medicine is one that claims to be one substance, but is fact another entire...

An annual report just issued by the US Customs and Border Patrol (CBP) shows that counterfeit and pirated goods experienced "explosive growth" in 2012, causing problems for healthcare product regulators who continue to struggle with ways to prevent counterfeit products from entering the supply chain. The Scale of the Problem: Big, but less so for Pharmaceuticals Purveyors of counterfeiters often use a tried-and-true tactic to get counterfeit products into the country:...

US President Barack Obama has signed into law three pieces of legislation that affect-directly or indirectly-the activities of the US Food and Drug Administration. User Fees Front and Center The first, and perhaps the most important, bill  was House Joint Resolution 117, the Continuing Appropriations Resolution of 2013 . The bill would maintain funding for US government agencies at fiscal year 2012 levels. While not specifically aimed at FDA, without the legis...

A piece of legislation set to increase the amount of fines and severity of penalties for counterfeiters and thieves of medical products has passed both the US House of Representatives and Senate by unanimous consent. The legislation, known at the Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act of 2010 (SAFE DOSES Act ) , was first introduced in March 2012 by Rep. James Sensenbrenner (R-WI). As reported by Regulatory Foc...

The US Food and Drug Administration (FDA) has developed a new tool it contends will assist the agency in its fight against counterfeit drug products, reports Med Page Today . The device, known as the Counterfeit Detection Device Number 3, or CD3, emits 10 wavelengths of light over products, including the packages and certifying documents they come with. The wavelengths, comprised of both visible and invisible spectrums, alert inspectors to potential issues and likely fo...

China's State Food and Drug Administration (SFDA) has issued guidance to provincial and municipal food and drug agencies and the Chinese Institute of Food and Drug Testing concerning the implementation of goals contained within China's national 12 th Five Year Plan. The plan calls for accelerating "rapid drug testing technology research" to detect counterfeit and adulterated drug products.  The guidance explains SFDA will be responsible for organizing a nat...