Related: Meta &: 303

June 22, 2011 § Leave a comment

In from lawyer Senak @ fda watch( something like this) a welcome advisory..

Today, the FDA announced a new global initiative aimed at bolstering the safety of imported products. In the press release announcing the initiative, FDA Commissioner Hamburg notes that with the explosion of manufacturers and ingredients from around the globe all having a hand in the development of products – the distinction between domestic and imported products is “obsolete” and she calls for the implementation of a “dramatic change in strategy” to deal with the issues.

Unfortunately, there are limits to what the FDA can do and the steps outlined, while sensible and important, may not necessarily be described as dramatic. According to the release, there are four key elements needed to make the change:

1. The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality.

2. The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets.

3. The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology.

4. The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk.

These actions are a good start, but beg the question whether it is enough. Dr. Hamburg notes in her remarks that since 2000 imports have quadrupled and that FDA has increased the number of foreign drug manufacturing inspections by 27 percent between 2007 and 2009.

Risk recognition is how one makes a start: response is next and thru to the end game.

Collabs are good news, item 3 with its global meta promise potential could be excellent

Can’t say for folks in kiwi – I’d guess with medsafe on the way out and the new Aussie NZ therapeutics set up in the pipeline then there’d be a solid something there to look forward to. Assuming no compromise to its independence to and for its own constituency goes with the astroturf.


ps: omission blog 4: Meta & Material: 303 — * ad rem = to the point; aegrescit medondo = the remedy is worse than the disease!

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