Weekly Roundup – 5/25/12

This is it!  Memorial Day weekend!  BBQs, straw hats, white pants, white bucks, seersucker suits and shorts, flip flops, the beach, clam bakes, trashy novels, front porch rockers, fresh baked fruit pies, beefsteak tomatoes, corn on the cob!  Ah summer!

In the meantime, as we slip into summer like a pleasant warm bath, here are a few things of interest from this week:

• PDUFA Legislation Clears the Senate – The Senate passed PDUFA legislation known as S. 3187 – the FDA Safety and Innovation Act – yesterday by a 96-1 vote and expanding user fees until 2017.  Who would have guessed?  Bloomberg reports that the House may be voting on the legislation by next week.  The FDA Law Blog has carried an outstanding overview of the amendments that passed along with the Senate legislation.
• Drugmaker Offers App as Drug Goes Generic – When a drug is going to face generic competition, it is important to consider ways for the brand name to offer a premium that comes with the brand in order to set it apart from the generic.  Years ago that might have taken the form of some kind of support tool offered through a web site.  That might be outmoded today when instead it might mean offering support for brand users through the use of an app.  This week Pfizer announced a partnership to provide an app to provide support for people on Lipitor.
• FDA Holding Public Meeting on International Food Safety – On June 19, from 9:00-5:00 FDA will be holding a public meeting entitled “International Capaicty Building with Respect to Food Safety” at the L’Enfant Plaza Hotel in Washington, D.C.  FDA states that the purpose of the meeting is to provide interested parties the opportunity to discuss the agency’s plan to expand the capacity of foreign governments that export food to the U.S.  The closing date for registration is June 11, 2012 and the closing date to submit either electronic or written comments is set for July 20, 2012.

That’s it for me this week.  As we begin the summer, let’s also remember and honor the valor of the fallen.  Have a good weekend everyone.

Photo credit:  Anne Hainsworth.