Newly appointed US Food and Drug Administration Commissioner Margaret Hamburg and FDA Principal Deputy Commissioner Joshua Sharfstein provided a broad vision for FDA in a recent New England Journal of Medicine article by asserting that the primary role of FDA should be as a public health agency and stressed the value of building collaborative models with other federal agencies, industry, and other national regulatory bodies in serving that function. Read more »

Ever since USP released its stimuli article last fall regarding the new, pending General Chapter <231> on Heavy Metals, industry has been up in arms about the proposed changes. Pharmaceutical manufacturers are uncertain of how they are going to move from purely wet-chemistry methods to more complicated, not to mention more expensive, methods such as inductively coupled plasma-mass spectrometry (ICP-MS), graphite furnace-atomic absorption spectrometry (GF-AAS), and cold vapor AAS to test their products for metal impurities. Read more »

The United States Department of Health and Human Services (HHS) is trying to cover all of its bases as it seeks to stockpile a vaccine to fight influenza A (H1N1). GSK and Sanofi are first on the list of drugmakers that will work with HHS to meet its objectives. Research scientists are also preparing for possible drug-resistant strains by making progress toward a new type of drug that will be able to stop the spread of infection and possibly prevent initial infection. Read more »

A report issued this week by the Biotechnology Industry Organization, the research institute Battelle, and the Biotechnology Institute, an organization that promotes biotechnology education, says the United States is failing to prepare students for pursuing biosciences in higher education. The report finds a wide disparity across measures of student achievement in overall science and biosciences, an uneven record across states in incorporating the biosciences in state science standards, supporting focused bioscience education programs and higher level bioscience courses, and ensuring science and bioscience teachers are well qualified. The report is based on a study of middle and high school bioscience education in the 50 states, Puerto Rico, and the District of Columbia. Read more »

We’ve all seen trademarked skeletons, wall charts, calendars, paperweights, and supplies in doctors’ offices. And it’s blatantly clear that these items came from pharmaceutical companies—their names are written all over them. But soon, those long waits in the examining room before the doctor comes in may be quite boring because there won’t be much to look at. Read more »

Pfizer’s Free Medicines program, “Maintain,” launched last week, promising to offer relief to many newly unemployed Americans. It seems like a good idea, and perhaps it will shine a positive light on the industry. Unfortunately, Big Pharma’s good intentions may be overshadowed by new accusations of overcharging state Medicaid programs. 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 »

“To the victor belongs the spoils,” goes the saying, but two emerging pharmaceutical companies, Epix Pharmaceuticals and Progenics Pharmaceuticals, show how difficult it is for smaller pharmaceutical companies to live up to that axiom during the financial downturn. Both companies earned a coveted prize in 2008, FDA approval of a new molecular entity (NME), and both have collaboration agreements with Big Pharma. But as is the case with many companies, restructuring and strategies for cash conservation are the order of the day. Read more »

Thousands of people, enormous halls separated by mile-long walkways, huge machines promising to deliver efficient, cost-effective solutions, dancing jumpsuit wearers, superheroes, robots, and one pair of very sore feet. This is my first experience of Achema. Read more »

In response to the swine-flu outbreak, the European Medicines Agency (EMEA) last week authorized the use of Tamiflu (oseltamivir) capsules up to two years after the drug’s prescribed expiration dates. EMEA’s Committee for Medicinal Products for Human Use (CHMP) specifically extended the shelf-life of Tamiflu 75 mg, 45 mg, and 30 mg hard capsules from 5 to 7 years. Read more »