A last ditch effort to bring safety to the medical device provisions of 21st Century Cures Act was stymied in the U.S. House Tuesday night.
Rep. Louise Slaughter (D-NY), a senior member of the House Rules Committee, proposed amending the Cures Act with Rep. Mike Fitzpatrick’s Medical Device Guardians Act (H.R. 5404).
You can watch the proceedings of this meeting here – at 8:30-11:30 minutes.
Slaughter and Fitzpatrick proposed this amendment and H.R. 5404 because they recognized that the power morcellator disaster in women’s health was a result of “self-reporting” failure on the part of expert physicians.
It is striking, however, to witness that in response to Slaughter’s concern about American women, Rules Chairman Pete Sessions (R-Tex.) seems more interested in talking about the weather in Texas and Washington.
Then comes Rep. Fred Upton (R-MI), who appears not to understand the amendment, stating, “FDA has the authority to withdraw the device from market”. FDA already has put a black-box on the power morcellator because of its oncological risk.
What Upton doesn't appear to grasp is that this device was harming women for over 20 years without having been reported to the FDA – and that the Fitzpatrick/Slaughter amendment sought to rectify that by encouraging expert physicians to self-report problems to public health officials.
When powerful politicians are more interested in the weather and in budget allocation than in saving lives, unsuspecting Americans will remain in harm's way.
Read more from the Check Up blog »