The Office of the Inspector General at the US Department of Health and Human Services (HHS) issued a report this month citing the US Food and Drug Administration’s need to improve its oversight of foreign clinical trials. The report raises questions over the effectiveness of federal regulatory practices and resources to keep pace with an increasingly global pharmaceutical industry, and in doing so, also engenders larger policy considerations on how to best address this problem. Read more »

It looks as though pharma is following GlaxoSmithKline’s lead in increasing efforts to provide people in developing countries with access to needed medications. GlaxoSmithKline (GSK, London), led by CEO Andrew Witty, has been on the forefront of this effort for some time—its largest contribution being the availability to the public of 13,500 malaria compounds for research and development (see  back story, “GSK Promotes Open Innovation, Help for Developing Countries”). Read more »

Written by Dr Brian D. Smith

I’m researching a new book about what our industry will look like once the great forces of globalization, biotechnology and market maturation have reshaped the pharma sector. One of the things that emerges is that the current industry landscape is itself the result of powerful political, economic, technical and social forces that strategic management geeks like me call the remote market environment. 
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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.

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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.

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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.

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