You may or may not remember how this one went down but HHS Secretary Sebelius decided to step in here and over rule the FDA but then a judge over ruled her. It was political and just a weird thing the way she played it out publicly I thought as the FDA works for HHS and that was in poor taste but the judge said it better than anyone else when he reversed that decision.
“Judge Korman also raised the issue of politics, saying that Ms. Sebelius’s decision was “politically motivated, scientifically unjustified, and contrary to agency precedent.” “
Judge Orders Morning After Pill to be Available for All Ages, Thus Nullifying HHS 2011 Recommendation to Restrict That Countered FDA Recommended Approval–Science Prevails
I had my comments too back in 2009 and probably more than me are getting a little more critical these days as that GOP thing seems to be spreading to the DOJ too with some of what I am reading in the news today too. The link below is one which many commented on who have tech backgrounds and found it odd, and again in my opinion showed a bit of lack of knowledge here with what technology can do, hospitals and doctors learned to bill better and then the following month we had the big announcement of the record amounts of money recouped with fraud efforts…folks that have no hands on with some area of technology themselves say silly things and run scared as data mechanics knowledge goes a long ways with more than just knowledge, you think more logically too. Did that to me.
HHS and DOJ Send Letters to Hospital Trade Associations Warning of Gaming Billing System Via Use of Electronic Medical Records–Hospitals Just Learned How to Bill Better & Hired Consultants–Case of Being Algo Duped With Numbers?
So Teva let their application stand as filed and who know what the next approval might be with age limits…the judge opened the door. BD
The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women’s Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years of age and older.
After the FDA did not approve Teva’s application to make Plan B One-Step available over-the-counter for all females of reproductive age in December 2011, the company submitted an amended application to make the product available for women 15 years of age and older without a prescription.
The product will now be labeled “not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified.” Plan B One-Step will be packaged with a product code prompting a cashier to request and verify the customer’s age. A customer who cannot provide age verification will not be able to purchase the product. In addition, Teva has arranged to have a security tag placed on all product cartons to prevent theft.