The House Committee on Oversight and Government Reform asked Johnson & Johnson CEO Bill Weldon to testify at a second hearing to explore the company’s recent massive recalls of over-the-counter medication, according to reports this week (see Reuters and Bloomberg). Weldon was unable to attend the committee’s May 27 hearing because he was recovering from back surgery at the time. Read more »
In an online commentary in the New England Journal of Medicine, US Food and Drug Administration Commissioner Margaret Hamburg and the National Institutes of Health (NIH) Director Francis Collins provided their perspectives on the challenges and opportunities in personalized medicine and the ways in which FDA and NIH are seeking to facilitate scientific and commercial efforts in this still nascent field. Read more »
As more and more tidbits about Johnson & Johnson’s product recall crisis fill the news waves, concerns over supply-chain security and drug safety are rising yet again. Consumers, not to mention Congress, have not forgotten contamination issues with toothpaste, pet food, infant formula, heparin—the list goes on—and the pharmaceutical industry has been pounded with questions about how it’s managing its manufacturing process as well as how it’s monitoring its supply and distribution channels. There should be light at the end of the tunnel given the numerous efforts made by standard-setting and regulatory bodies on this issue.
McNeil Consumer Healthcare/Johnson & Johnson is expanding its Jan. 15, 2010, recall to include four lots of Benadryl and one lot of Tylenol, the company announced on Tuesday. The company said these products were “inadvertently omitted from the initial recall action,” which took effect because of consumer reports of a moldy, musty odor from the medication. As in previous recalls, McNeil said that the risk of serious adverse events is remote. Read more »
Earlier this month, Apple’s iPad hit the streets of Europe. In the US, the company sold more than two million in the first 60 days of its release and, although we don’t know sales figures for Europe yet, consumer interest has been feverish. 2010 predictions of more than 6 million units worldwide no longer seem ambitious. Apple kicked off its European iPad sales in France, Germany, Italy, Spain, Switzerland and the UK, with universal availability expected before the end of the year.
In a speech before the Detroit Economic Club last week, John C. Lechleiter, chairman, president, and CEO of Eli Lilly, addressed what he regards as declining competitive scientific advantage in the US and the policies that he thinks are important for the US not to lose its position in the life sciences. Read more »
It’s been four years since the International Conference on Harmonization adopted ICH Q3B(R2), which harmonizes the content and qualification of impurities in drug substances, including extractables and leachables (E&L) produced by the interaction of a drug substance and its container-closure system. And yet, there still seem to be a huge amount of questions surrounding these degradation byproducts, stability testing, thresholds, and reporting requirements.
The calamitous and ongoing Deepwater Horizon oil spill has brought pollution to the center of the public consciousness again. The environmental effects of the petroleum industry’s operations have been the subject of public scrutiny for years. The current spill has understandably focused regulators’ attention on oil pollution, but we should remember that other sectors, including the pharmaceutical industry, can sometimes release pollutants into our waterways, too. Read more »
No matter what governmental bodies do—be they at the state, national, or international level—there is always a group against them. Of course, this is one reason politics and political parties exist—to sort out disagreements among individuals and organizations and, ideally, to find compromise. Political and ethical issues are now surrounding the World Health Organization (WHO) and its handling of the H1N1 swine-flu, which appeared in 2008/early 2009 and quickly spread around the world. WHO declared the situation a Phase 6 pandemic in June 2009. (There are six official pandemic alert Phases with Phases 6 being the highest level, based on human-to-human spread of the virus in at least two countries in one WHO region and at least one additional country in a different WHO region. The Phase descriptions are on the WHO website). Read more »
Last week’s McDonalds glassware recall is another example of the problem of heavy metals appearing in consumer products. The fast-food giant, in cooperation with the Consumer Product Safety Commission (CPSC), recalled its promotional Shrek glassware because of the elevated level of cadmium found in the glasses. Read more »
From PharmTech.com