FDA Releases A Report On Driving Biomedical Innovation

FDA released “Driving Biomedical Innovation: Initiatives for Improving Products for Patients.”a new report today, The report outlines “immediate steps that can be taken to drive biomedical innovation, while improving the health of Americans."

The blueprint focuses on implementing the following major actions:

• rebuilding FDA’s small business outreach services
• building the infrastructure to drive and support personalized medicine
• creating a rapid drug development pathway for important targeted therapies
• harnessing the potential of data mining and information sharing while protecting patient privacy
• improving consistency and clarity in the medical device review process
• training the next generation of innovators
• streamlining and reforming FDA regulations.

It is very timely and we are in need of it.

FDA released a report containing immediate steps that can be taken to drive biomedical innovation, while improving the health of Americans. The report addresses concerns about the medical product development pipeline, one of the most pressing challenges facing the biomedical industries.
Release of the report, kicks off a new FDA-wide Innovation Initiative, which promises to redouble the agency’s efforts to encourage innovations that will promote public health as well as strengthen the American economy.
We are committed to continuing our dialogue with companies, innovators, patients, and other stakeholders to identify barriers to progress and better define what steps need to be taken to overcome any obstacles to innovation.
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Press Release: FDA commissioner outlines steps to spur biomedical innovation, improve health of Americans
Fact Sheet

Despite Recalls Drug Companies Stand By China.

As we informed today that FDA itself is seeking to establish FDA offices in China, Boston Globe has an article that despite worldwide recalls of Chinese made drugs, more and more drug companies are flocking to China to reduce production costs, and of course larger profits.
Of course when questioned the companies say problems such as the recent heparin related deaths in the USA and the subsequent all heparin recall in USA and Germany, Panama's antifreeze lazed medicine and the tainted leukemia drugs found in China itself are isolated incidents. They say they have the same quality-control standards in China. But I wonder if they are following these standards.
The article mentions the FDA itself thinks that there are many companies that follow the rules while there many who are in the other end of the spectrum. ""While some Chinese [drug] companies are state-of-the art in technology and manufacturing expertise, many are at the opposite end of the spectrum," FDA deputy commissioner Murray Lumpkin told Congress last year."
What ever the reasons, it is hard to believe the damage these drug companies are causing to general populace. So I invite you to read this article by Boston Globe, which tries to look at the issue from many fronts, including Massachusetts's own companies that manufacture drugs in China.
tag: Drug Companies, Drug Manufacture, FDA in China, heparin recall, Chinese made drugs,