My first reply to a StripSafely letter from Congress was a long piece that included the history of the FDA and nothing about the subject to which the good Senator was replying, meter accuracy. I shared it with some friends who were a little disappointed.
Yesterday I received a letter from my Congresswoman. (Yes, woman. Cool right?) She (or her staffer more accurately) wrote specifically about FDA post market oversight. Citing exactly the three points FDA wants me to hear; inspections, MDRs and recalls. That is glorious. That can only mean the Congresswoman’s office reached out to FDA. The FDA had some explaining to do to the Hill.
Each episodes of the “A-Team” ended with Hannibal saying, “I love it when a plan comes together.” The joke being that things may not go as planned but the A – Team gets results, typically with a lot of action.
I know the FDA has action hero-ish special abilities. On September 5th the Agency published a story of how twenty one individual, potentially contaminated, candy bars from New Zealand were tracked down by FDA to keep American consumers safe. FDA should just as actively use its powers for good to Americans safe from test strips that fail to deliver the accuracy on our fingers that those test systems had to demonstrate to be approved for sale.
If anything is clear from the Diabetes Technology Society meetings on May 21 and September 9, it is that we know there is a problem. We know firms fail to comply with MDRs and other parts of FDAs existing regulatory controls. Committees, commissions and post market studies to know more, without enforcing more, is unacceptable.
We need acton for plan to come together.
People with Diabetes are starting to get the FDA’s attention. StripSafely is still in the opening of the third act. Regular viewers know what is needed, action, lots of it.
If you get a reply from you Congresswoman (or man) that mentions three parts of a post market program, write back. Tell congress we need more action, independent inspection. We have a letter for that. Face and BA are in shed beating the Strip Safely Twitter page into shape too.
The third act is always the most fun.
(My lodging to attend the September 9 meeting was paid for by the Diabetes Hands Foundation.)