We all depend on the US Food and Drug Administration to enforce standards that keep our drugs safe. We expect the agency to set clear guidelines for consumers and manufacturers to follow. We also assume that the agency has standards for its own activities and ways of ensuring that agents comply with those standards. Unfortunately, a recent report from the US Government Accountability Office (GAO) shows that FDA has not entirely lived up to our expectations. Read more »

The numbers are in, and it looks like 2009 produced a bumper crop of biopharmaceuticals. The US Food and Drug Administration approved a record 16 new biopharmaceutical entities last year, as opposed to 10 in 2008, according to a study by the Biotechnology Information Institute. Seven recombinant-protein or antibody products were approved last year, continuing an upward trend for these molecules. Great news, right? Read more »

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 »

A new study published in the American Journal of Public Health claims that prescription drug direct-to-consumer advertising (DTCA) can be harmful to a person’s health. According to the researchers, prescription drug advertisements are “not doing a good job of helping consumers to make better decisions about their health”. Read more »

The proliferation of online health information and media vehicles such as blogs and social-networking sites create a new problem for the consumer—how to judge the reliability of such information. To address that problem, the US Food and Drug Administration is holding hearings this week, Nov. 12–13, in Washington DC, regarding the promotion of FDA-regulated medical products using the Internet and social-media tools. The hearings, which will include participation from pharmaceutical trade associations, drug companies, consumer groups, and media representatives, is the first step in a public dialogue that FDA is having as it evaluates how the statutory provisions, regulations, and policies concerning advertising and promotional labeling should be applied to product-related information on the Internet and newer media technologies. Read more »

In just a few weeks, FDA will hold its public meeting to discuss the use of social media tools in marketing pharmaceutical drug products. (See back story.) The last time the agency held a meeting to discuss these types of items was in 1996 when the Internet’s popularity was growing by leaps and bounds.   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 »

Two recent news reports provided some good news for a change. First, FDA announced plans to award $2 million in grants for the development of pediatric medical devices. Read more »