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Food and Drug Administration Safety and Innovation Act

Floor Speech

Location: Washington, DC


Mr. MARKEY. I would like to thank Chairman Upton and Chairman Pitts and Ranking Member Waxman and Ranking Member Pallone and their staffs for their work in bringing the FDA Safety and Innovation Act to the floor today.

Passing this bill will allow the FDA to continue its critical mission of bringing safe and effective drugs and medical devices to the patients who need them. Reviewing drug and device applications has become increasingly challenging. Medical breakthroughs of today often target rare diseases or genetic subsets of those diseases. FDA reviewers must now assess a growing pipeline of very specialized treatments.

I'm pleased that this bill includes language I helped author to improve collaboration between FDA and external experts in rare diseases like cystic fibrosis and sickle cell disease.

The bill before us today also includes an important provision I helped author to ensure that the millions of Americans who are blind or visually impaired have safe and independent access to the information on prescription drug labels. No one should have to sacrifice their privacy or independence to access the vital information on these bottles, and I'm glad we're taking steps to address that here today.

Finally, this bill helps increase the availability of pediatric medical devices and ensures that medications are tested and labeled appropriately for children. I was proud to work on these provisions with my colleagues, Congresswoman Eshoo and Congressman Rogers.

I would have liked to have seen additional measures included in this bill to ensure the safety of medical devices based on defective models that have already been approved by the FDA, that unfortunately continue to be sold and jeopardize patients' health all across this country. I am going to continue to work on this critical issue. I believe it's a problem that we must solve. Once the FDA approves a device and then it turns out that there's a defect, there should be no excuse for allowing new companies to build their devices based upon the old approved defective model that the FDA had approved. Tens of thousands of Americans are put in jeopardy, and I would like to work to solve that problem.

Nonetheless, this is an excellent piece of legislation, and I hope that the House gives it its overwhelming approval.


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