We are nearing the end of the year and there is lots to do. Thanksgiving, Christmas shopping and then Congress has about 1000 things left undone, even by those members who aren’t running for president. Here is a little of what has transpired over the past week or so:
- Congress Holds Hearing on FDA Inspections of Foreign Manufacturers – The Washington Post reported yesterday that the FDA is inspecting foreign manufacturers of pharmaceutical ingredients only once every eight years or so, due to under-staffing – in spite of the fact that they are a growing contributor to pharmaceutical products. Perhaps this means a Foreign Manufacturers User Fee Act? Given that China is a major contributor and has had its share of headlines lately with regard to quality and inspections, you can do the math. At any rate, the article reports, a hearing was held yesterday and FDA Commissioner Andrew C. von Eschenbach testified and the FDA put the testimony up on the site in short order.
- IMS Issues Report Predicting Slower Growth for Pharmaceutical Companies – IMS, the world’s leading provider of market intelligence to the pharmaceutical and healthcare industries, announced that growth in pharmaceutical sales for 2008 would likely be slower than it was in 2007 due to a number of factors. Among the many factors cited as responsible are the wave of generics coming on line, safety issues, and challenges to intellectual property.
- Pharmaceutical Executive Publishes Article on Approvable Letters – As I’ve written many times, it appears that the number of approvable letters has increased dramatically. In this month’s issue, the magazine looks at the issue interviewing a number of experts, including myself! Check it out.
- Adams Respiratory Gets Approvable Letter – Speaking of which, the FDA issued another approvable letter – this time to Adams Respiratory for Mucinex(R) with Codeine (guaifenesin 600/1200 mg and codeine phosphate 30/60 mg) extended-release bi-layer tablets. According to the company release, the agency was asking for some labeling changes, but also wanted additional data. The COO is quoted as saying that this is a "positive step" – which it is compared to a non-approval, but is of course, less positive than an approval. So many approvable letters have been issued this year, it is interesting to see how companies characterize their receipt.
That’s it for this week folks. Have a good weekend.