Eye on FDA

Spring is not waiting for the Vernal Equinox.  Spring didn’t even wait for winter – it feels like it has been here for a while.  Daffodils are already in full bloom around town, tulips up.  If you were planning on coming to town to see the cherry blossoms, you may want to note the fact that it is looking increasingly as if they will pop early.   And one gets the sense that summer may start in late March and given the election year, it is bound to be a long, hot summer.

It certainly heated up this week around here.  And these are a few things that were interesting from my vantage point, which admittedly was limited due to another hectic week:

• Graphic Cigarette Packs – Not So Much – A not so surprising development this week when the U.S. District Court in Washington struck down the proposed graphic packaging for the marketing of cigarettes in the U.S.  The court had already put the packs on hold last Fall and struck down the effort saying that it violated the First Amendment of the Constitution, essentially because the images weren’t designed to convey information but to evoke an emotional response.  Mum was the word from FDA in the wake of the ruling but HHS issued a rather vague statement expressing determination to “warn young people about the dangers of smoking” and confidence that efforts to stop the packaging will “ultimately fail.”
• NIH Launches Genetic Testing Registry – Change happens.  Only a few years ago, the need for a registry to track genetic testing might have seemed very futuristic but today is reality.  This week NIH announced such a registry.  According to the release there are now genetic tests available for approximately 2500 diseases (who knew?) representing a field with a rapid growth rate.  Information included will be the “purpose of each genetic test and its limitations; the name and location of the test provider; whether it is a clinical or research test; what methods are used; and what is measured.”  You can find the registry here.
• Statins Get a New Label Warning But I Forget Why – Just kidding – on the latter part anyway.  FDA announced this week safety changes in labeling for statins used to lower cholesterol.  The changes to the labels involve a revision to remove the need for routine periodic monitoring of liver enzymes.  That is interesting in and of itself.  In addition, the label will add information about some patients experiencing some memory loss and confusion, though the reports were termed as having “not been serious” – which raises a question.  Also included is information about increases in blood sugar levels.  More on some of this next week.

Wherever you are and whatever you are doing, I hope you have a wonderful weekend.  That’s all for me this week.  (Photo taken by friend Anne Hainsworth and used with permission)

I have been super-busy, as you may have discerned from my recent lack of correspondence here.  But I am not alone!  Things have been hopping from the FDA perspective, and here are a few things that occurred this week that I thought I would pass along:

• FDA Advisory Committee Overwhelmingly Recommends Approval of New Weight Loss Medication – To the surprise of many, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) at a meeting this week voted 20-2 in favor of recommending approval of Qnexa sponsored by Vivus.  There had not been a weight loss medication approved since 1999 in a category that has proven to be a tough one along many fronts.  In a previous go at approval, the sponsor received a Complete Response Letter in 2010, which was the fate of two other candidates in the category that year.  This is evidence of just how dicey predicting advisory committee outcomes can really be.
• FDA Takes Action on Drug Shortage Issue – FDA announced this week steps that it was taking to address the on-going and well-publicized drug shortage issue as it respected two medications.  The first was Doxil, used in multiple treatment regiments, including the treatment of ovarian cancer after failure of platinum-based chemotherapy, Kaposi’s sarcoma and multiple myeloma. FDA will be allowing the temporary importation of a replacement drug called Lipodox.  In addition, FDA approved a new manufacturer of preservative-free formulation of methotrexate to help supply.  In addition to a release on the action, FDA Commissioner Margaret Hamburg wrote a blog post on the new FDA blog FDA Voice. In addition, FDA published a draft guidance on drug shortages.
• Draft Guidance on AE Reporting – Less in the news, but interesting nonetheless, was a draft guidance issued today by FDA that is entitled “”Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic“.  Not as catch of a title as “Love in the Time of Cholera” it is nevertheless interesting precisely because it is so peculiar.  Six years ago, there as a lot of discussion and preparation around the potential for a serious flu pandemic and while it has receded from headlines for the most part, it is still poses a serious threat.  According to FDA, the guidance outlines the agency’s enforcement of AE reporting during an epidemic when there may be a high level of disruption to systems and high employee absenteeism.

That’s it for me this week.  Have a wonderful weekend everyone.  We are edging ever close to Daylight Savings Time on March 11!