Weekly Roundup 7.25.14

We sit on the cusp of August – the month when America goes on vacation.  Everything will slow down, rush hour will be less rushed, lawns will need less cutting and in our sights is Labor Day which brings the laziness of the season to an abrupt end.

But before that happens, let’s examine a few things from the week that might be of interest:

  • Link to Webinar on FDA and Social Media – On July 17 I gave a Webinar entitled “In More Than 140 Characters:  FDA’s Social Media Guidance Past, Present and Future” to which there was a large turnout, but also some folks who had signed up and could not make it.  For those, and for others who may have wanted to sign up but had a conflict, here is a link to a playback of the Webinar. To those of you who came, thanks for joining me!
  • FDA Approves Oxycodone with Abuse Deterrent – In a long-standing effort to create circumstances that make needed pain medication available that does not feed abuse as well, FDA this week announced approval of an oxycodone product that has abuse deterrent properties.  The product is an extended release/long-acting opioid analgesic called Targiniq ER and works by including naloxone so that when the tablet is crushed in any way for use, the naloxone blocs the euphoric effects being sought.  This does not preclude its abuse when taken orally.  The product is indicated to treat pain that requires daily, around-the-clock, long-term opioid treatment for which alternatives are inadequate and is not indicated for as-needed pain relief.  It is the second approval for extended release/long acting product approved since the agency’s 2013 draft guidance on Abuse-Deterent Opioids.
  • US and Mexico Sign Statement of Intent on Produce Safety – For those who remember the 2008 Tomato scare when tons of tomatoes from Mexico were destroyed in the belief that they were connected to an outbreak of salmonella – well there was a lot of criticism to go around.  This week FDA announced that FDA Commissioner Hamburg met this week with Mexican counterparts to discuss ways to strengthen cooperation in support of produce safety.  The news release outlines several areas of cooperation meant to put into place preventive practices which appeared more to be aims and goals than actual policies and procedures – an observation seemingly affirmed by the posting on FDA’s blog about the two-page statement of intent between the two countries.

It is a beautiful day here in Washington, D.C. and I hope that it is for you wherever you are as well.  Have a wonderful weekend.

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