Showing posts with label Andy's Take. Show all posts
Showing posts with label Andy's Take. Show all posts

Thursday, December 11, 2008

Communication is the key – How is the FDA extending communication on Threats to Public Safety?

To better reach the public on safety issues throughout the pharmaceutical supply chain, the Food and Drug Administration (FDA) is collaborating with WebMD. This will allow the FDA to expand its Consumer Health Information and give the consumers important information on product recalls and emerging public health safety issues in a timely manner.

FDA’s website currently gets 6 million viewers a month from the regulatory pharmaceutical industry while the WebMD site is geared to consumers and gets 49 million viewers a month.

This extends the FDA’s current efforts in consumer communications such as “Andy’s Take” which is a weekly online audio broadcast on the FDA initiatives in ensuring public safety.

Consumers can access the latest FDA information on WebMD’s “Protect Your Health” page. Information is provided for food safety, medication safety, cosmetic safety, product recalls and a guide to reporting problems to the FDA.

We, at XStream Systems applaud the FDA on their expansion of communication with the general public. This combined with patient’s ability to communicate problems back to the FDA completes the two-way communication needed between patients and the authority that regulates their medications.

Monday, July 14, 2008

The Challenges of Product Safety in a Global Market Place

Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs Administration recently spoke at the Import Safety Summit and posted his view of import safety in his newsletter Andy’s Take:

“You are aware that an increasing number of products – especially those affecting your health, like food and medical products – are being imported from beyond our borders. This has raised great concern recently about FDA’s ability to ensure the safety of those products. This week, I attended a summit with hundreds of industry leaders to collectively address the challenges of product safety in a global market place.

My take is that the challenge of imported product safety will increase because as American consumers, we have come to expect - and even demand – year round variety in the food we eat. And because the production of many of the drugs and medical devices we use is now a global enterprise. So if we are going to want safety in all these products, it will require a collective effort, through collaboration with industry and international regulatory counterparts. This is to build safety in to the production of food and medical products as well as to create systems that assure their safety through distribution and consumption.

That’s why the FDA is accelerating initiatives like our participation in a groundbreaking program with partners in the European Union and Australia. Through a new pilot program we will jointly plan, allocate, and conduct certain inspections of facilities in developing countries that manufacture the starting materials for many of the drugs you take. If this program is successful, it could be expanded to include other types of drug manufacturing facilities. By leveraging the resources of each agency and sharing vital information, the number of foreign facilities in our inspection data base expands while allowing FDA to target its resources on products that we believe present the highest risk to US consumers.”

We at XStream System agree with Commissioner vonEschenbach on the importance of safety throughout the distribution chain and believe that the molecular pharmaceutical authentication possible with the XT250™ Material Identification System will further the industry’s ability to ensure safety to the consumer.