We take for granted that drinking tap water is not going to alter our mood and that eating salmon is not going to throw our hormones out of balance. But trace amounts of pharmaceuticals have been found in drinking water and aquatic life, raising questions about how these chemicals could affect human health. Local and federal governments began to address the issue this year, and a new project by the Environmental Protection Agency (EPA) could be the basis for future solutions. Read more »

Last week, Genzyme’s (Cambridge, MA) Allston Landing, Massachusetts, plant resumed production of Cerezyme, the company’s treatment for Gaucher’s disease. Genzyme presumably found and eliminated the source of contamination that had been reported weeks earlier. You’d think that after putting out this latest fire at the troubled plant, the company would be justified in heaving a sigh of relief. Read more »

Friday the 13th was an unlucky day for Genzyme (Cambridge, MA). On that day, the company and the US Food and Drug Administration alerted healthcare providers that stainless steel fragments, nonlatex rubber, and fiberlike material had been found in products filled at Genzyme’s Allston Landing manufacturing facility. The enzyme-replacement products Cerezyme, Fabrazyme, Myozyme, Aldurazyme, and Thyrogen were affected. FDA advised that visual inspection and filtration of the products should reduce the risk of administering contaminated medicines to patients. Read more »

The US Food and Drug Administration has taken a lot of heat in recent years. Events such as the heparin scandal and the recall of Actavis’s (Morristown, NJ) Digitek product have led critics to call the agency a lax and ineffectual protector of the public health. These comments, which I think are partly justified, finally seem to have spurred FDA into action. Several initiatives seem to show an agency that wants to regain its credibility and shield us from dangerous medications. Read more »

News reports about adulterated drugs seem to have been replaced by stories of contaminated food products. Cases of salmonella related to products that contain peanuts and pistachios are the latest examples. The US Food and Drug Administration has been blamed for failing to protect consumers, and commentators have cited outdated policies, inadequate staffing, and insufficient funds.

In February 2009, Rep. Rosa DeLauro (D-CT) proposed creating a separate Food Safety Administration to improve oversight of food products sold in the United States. But a recent FDA Warning Letter suggests that drawing a line between food and drug products might not be so simple. Read more »

As an editor for Pharmaceutical Technology, I often hear about novel drug-delivery mechanisms. Often they’re high-tech materials such as polymers, hydrogels, or nanoparticles. But a recent Associated Press story revealed a biological-based drug carrier that I hadn’t thought of: fish. Read more »

I haven’t been involved in the pharmaceutical industry too long, but long enough to have learned that regulations are the bane of manufacturers’ existence. I’m actually a proponent of stringent regulations—perhaps because I’m somewhat of an outsider and don’t have to deal with the actual paperwork or inspection process. But given the extreme cases of contamination (e.g., heparin, melamine, DEG) and violations of late, even among large, well-respected pharmaceutical companies (e.g., Bayer’s unapproved drug marketing, Ranbaxy’s GMP-facility violations), it seems that strict oversight and controls are truly necessary.

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One of the US Food and Drug Administration’s most important jobs is to provide the public with clear information about drug safety. Representative Joe Barton’s (R-TX) recent letter to the US Government Accountability Office (GAO) raises questions about whether FDA is telling us everything it knows. Read more »

Flexibility in bulk-solids handling is an important trend in pharmaceutical manufacturing of active pharmaceutical ingredients and dosage forms, an issue addressed by Richard Denk, director of the pharmaceutical department for Hecht Anlagenbau (Pfaffenhofen/Ilm, Germany) at the conference session, “Disposable Containment Technologies for Bulk Solids,” at Interphex. Read more »

As a law in my state, drivers are not “allowed” to pump their own gas. I suppose it has helped the Oregon economy with providing additional (read: low wage) jobs. In turn, our gas taxes may be a little higher than the rest of the country’s. Last week, however, as I pulled up to take another hit to the family budget with another fill-up, I noticed a sign at the station declaring “diesel customers: you are responsible for making sure the right gas is pumped into your vehicle.” Read more »