Weekly Roundup 10-15-10

Now we are really in the swing of autumn.  Leaves, having lost their access to long hours of sunlight, are now shedding and filling the back deck with reminders of summer.  Halloween candy in gargantuan bags appears in grocery stores even though there seem to be fewer and fewer trick or treaters every year by my estimate.  Gone are the days of popcorn balls that I used to get as a kid (and loved!). Squirrels are scampering on the front porch nibbling at the pumpkin I paid $5 for at the grocery store and I am looking up squirrel stew recipes.

But on more important matters….

  •  FDA Moves to Withdraw Marketing License for Knee Device – Perhaps one could would  be tempted to call it a "knee-jerk reaction" and I only mention it to make you smile and have trouble resisting puns, not to make a point.  But FDA this week took the unusual action of moving to reverse itself on an approval of a device for the knee that it had previously approved in 2008, which I don't recall ever seeing before.  The FDA said it was taking the action after a September 2009 report that "identified problems" in the review of the orthopedic device and called for a re-evaluation.  Moreover, the New York Times reported that the agency was taking the action due, at least in part, to the fact that the agency had faced pressure from members of Congress to approve the device.  The device has already been used in Europe for a decade.  Yet apparently some whistleblowers complained that there was political pressure and the FDA was pressured to re-consider.  It all begs further the question as to whether members of Congress, in any capacity, should be involving themselves in approval decisions or decisions to rescind, since there is probably much more transparency in the FDA process than there is with any member of Congress.  
  • FDA Issues Warnings to Companies Selling OTC "Chelation" Products – This week the agency sent 8, count 'em 8, warning letters to companies selling OTC chelation products for marketing unapproved drugs.  The products were addressed to people with a wide range of conditions and the agency stated in their release that chelation products are prescription only and have specific uses that differed from the marketing efforts made by the companies. This is yet another of an ever increasing example of the FDA taking action that is sweeping in nature to address a seemingly widespread industry practice.    
  • International Internet Week of Action – For those of us waiting for guidance on the use of the Internet and social media by medical product manufacturers, this may have signaled one thing, but it meant an entirely other (though equally important) thing.  The above action regarding "chelation" products was taken, at least in part,  because of the many products appearing on the Internet for sale making claims.  One only has to do a search for treatment of any kind of disease and one can see paid search ads for miracle cures and offers to treat "naturally".   So it is no coincidence to the above action, that the FDA announced this week that it had participated in an international effort to raise public awareness about the dangers involved in Internet purchases from purveyors who promise treatments that have not been examined with scientific rigor.  The scope of the activities undertaken by the agency, including through the FDA's Office of Criminal Investigations was quite impressive.  The action is quite commendable, but given the volume out there, one wonders if more than a "week" may be required, but rather an on-going campaign – food for thought.

That's it for me this week folks.  I hope everyone enjoys their weekend.  Send squirrel recipes if you got 'em!



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2 Responses to Weekly Roundup 10-15-10

  1. Ralston says:

    great interviews with Dr Kessler. as you note, things have really changed at FDA.
    do you have any insights on how FDA will adapt handle increasing production abroad of drugs for US market? how long will someone like Ranbaxy have to pay penance for very bad behavior in generics?
    this seems to be one of the few breaks US drug companies have had lately, if it slows the onslaught of drugs from China, India, etc. thanks for your insights.

  2. Mark Senak says:

    Hi and thanks. I’m glad you enjoyed the Kessler interviews.
    With respect to your question on how FDA will adapt to increasing production abroad, I don’t have specific information, but I would refer back to something Dr. Kessler stated.
    I think that it is impossible for FDA to be everywhere around the world. It is not even feasible. So what will happen is that FDA will have to make sure that standards are set into place that companies not only must follow, but that which companies must continually report through on their ability to self-review and assure standards.
    And when a company fails to do so under such circumstances, I would think that it will take time to repair the damage done. (not, by the way, speaking specifically to the case you mention)

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