The Baxter Heparin Saga...pick your spin...

There are a lot of different ways to look at this issue...

- Writer's Scare Tatics..."Tampering possible in China"

- Troubleshooting drug safety is scientific challenge...heparin-like molecules

- FDA and manufacturer cooperate to maintain drug supply...Earlier this month, the firm stopped production, but the FDA wanted to keep the existing Baxter heparin in doctors' hands because it did not want to cause a shortage of the life-saving drug. Agency officials said increased production by the other heparin manufacturer can now satisfy the demand.

- FDA doesn't inspect overseas manufacturing sites...The FDA has averaged just 15 inspections in China in each of the last five years

- Lack of FDA oversight on imports...Flood of drugs, little oversight by regulators

- Outsourcing causes quality problems...Baxter’s Heparin Problems May Have China Connection

- Chinese quality control...Baxter tests point to Chinese problem

- Realtime crisis management...Call to action at Baxter

Manufacturer intitiates recall...Baxter Issues Urgent Nationwide Voluntary Recall of Heparin

Before you decide on which drum you think should be beat on, just remeber that these issues are harder to solve than you might think...

Pfizer plans more off-shoring and outsourcing

More on the off-shoring trend...previous post here

Pfizer is looking to Asia for both R&D and manufacturing outsourcing and to help it cut costs in a bid to mitigate the effects of patent expiries and competition from generic drugs.

Pfizer announced plans to increase its R&D presence in Asia at its Hong Kong investor meeting on Friday, while saying it is also look to double the amount of manufacturing outsourcing to 30 per cent.

The pharma giant has struggled in the past year and the high profile clinical trial failure of its cholesterol-lowering drug Torcetrapib has only matters worse.

Torcetrapib would have enabled Pfizer to defend the patents its cholesterol drug Lipitor (atorvastatin) that are due to expire in 2011, potentially creating a $13bn hole in the company's revenues.

In addition, Pfizer's pipeline has been criticised from many quarters, with even the company's new president of global R&D stating "I'm the first to admit [the drug pipeline] is not as rich as I'd like it to be."

To help combat this Pfizer will look to bolster its Asian R&D, targeting China, India, Japan and South Korea.

New sites in these areas would help the company bolster its share of the Asian pharmaceutical market which is predicted to grow to $200bn by 2017.

link to full article

FDA Considers Outsourcing 300 Jobs

I can't wait to see the action this one gets in the broader media market...

Lou Dobbs, for instance, is some one who should have a field day with this one...

WASHINGTON - The Food and Drug Administration may outsource hundreds of jobs to private companies, according to agency officials.

The government's chief health regulatory agency is reviewing more than 300 positions in more than 20 cities to determine whether they could be performed cheaper and better by the private sector. A decision is expected next month, according to FDA documents.

An initial list of positions under review included lab technicians and field office workers who work at FDA facilities where food and medical products are inspected for safety.

However, the FDA revised the list to include only administrative jobs that aren't directly involved in food safety inspections, Chris Kelly, an FDA spokesman said Wednesday.

The FDA's outsourcing effort comes amid increased public fears about the safety of imported food and other products. In July, the White House formed an Import Safety Working Group after a string of tainted products, including toothpaste, seafood and pet food, entered the U.S. from China.

link to full article

When India is having trouble finding qualified people, we're all in trouble...

Noted scientist Dr. K Muniyappa has regretted that though the number of colleges offering biotechnology degrees in the country has grown by leaps and bounds during the last some years, the quality of the education imparted in these colleges is a subject for deep concern.

"The Indian biotechnology sector is facing an acute shortage of trained manpower and there is a lack of initiative for development of competent human resources," he said. There is an urgent need for the Union government to earmark a portion of the budget towards quality training of manpower in biotechnology.

The observation by the research institutes and the industry is that the present knowledge among biotech graduates makes them unemployable. In the post-graduate sector, many of the candidates are even unfit for on-the-job training.

"With the growing popularity of biotechnology among the students, there has been a spurt in the number of colleges offering biotechnology degrees, but the quality of training offered is a question," Dr Muniyappa, professor and chairman, department of biochemistry, Indian Institute of Science told Pharmabiz. "

Graduate students contribute the most, if not all to our research output in many disciplines. In India, the emphasis is on training rather than research productivity. This has led pharma-biotech sector to insist for candidates who have either studied or worked abroad only because of the quality of personnel in India are just not employable," Dr Muniyappa, who is also the founding coordinator, National DBT Post-doctoral Programme in Biotechnology and Lifesciences, added.

link to full article

Pfizer plans to double drug production outsourcing

more on the pfizer situation...

25/01/2007 - Pfizer’s latest cutbacks will provide a new outsourcing opportunity for contract manufacturing organisations (CMOs) in low-cost destinations as the drug giant announces plans to double its amount of drug production outsourcing.

The plans were revealed during an analyst meeting on Monday, when the world's biggest drug maker also announced that it would shut down two US manufacturing plants - one in Brooklyn, New York and one in Omaha, Nebraska - and try to sell a third plant in Feucht, Germany, culminating in the loss of 10,000 jobs.
The closures will also affect research and development, with three R&D sites in the US being deemed surplus to requirements and possibly two more, in France and Japan, under threat.

Pfizer's restructure comes in the face of patent expiries for some of its biggest drugs and a corresponding sharp dive in revenues – profits dropped 43 per cent in the fourth-quarter of 2006 as generic products began to make their presence felt – as well as the recent failure of a late-stage pipeline project, torcetrapib, upon which the firm was pinning its new financial hopes.

link to full article