May 17, 2012
Washington, D.C. – Nevada Senator Harry Reid spoke on the Senate floor today regarding the Food and Drug Administration Safety and Innovation Act. Below are his remarks as prepared for delivery:
When someone we love gets sick the only thing on our minds is how to help them get them well – how to get them the care they need.
But before every miracle drug or innovative new device comes to market, there is a rigorous approval process to make sure that cure is safe.
To get life-saving drugs and devices to the patients who need them as quickly and efficiently as possible, Congress must give the Food and Drug Administration the tools it needs to review and approve those products.
Today the Senate will begin consideration of legislation that gives the FDA the resources to ensure medical devices, drugs and treatments are safe and effective.
I applaud the work of my colleagues, Senator Harkin and Senator Enzi, to bring this legislation to the floor.
I hope to see the strong, bipartisan effort these two senators began continue as the Senate considers this important measure.
The Food and Drug Administration Safety and Innovation Act authorizes the FDA to charge user fees of the manufacturers of new medical products. Those fees are used to ensure their products are reviewed quickly and thoroughly before they are and approved.
But this legislation does more than maintain the status quo. It also enacts crucial reforms that will prevent drug shortages and bring life-saving medicines to market more quickly.
It will save high-tech jobs in the medical field, make new treatments available to patients quickly and preserve America’s role as a global leader in biomedical innovation.
The legislation will expedite the process of approving new drugs and medical devices, including many designed for children, while ensuring those products are safe for consumers.
It will help spur the innovations that bring the next groundbreaking cancer or Parkinson’s drug to market.
The bill will hold foreign manufacturer who sell drugs in United States to the same high standards met by American companies.
And it will help prevent drug shortages by opening up the lines of communication between manufacturers and the FDA.
The Senior Senator from Minnesota, Senator Klobuchar, and the Junior Senator from Pennsylvania, Senator Casey, have been leaders on this drug shortage issue. I appreciate their efforts to safeguard Americans’ health.
Every day, hospitals across the country experience shortages of life-saving, FDA-approved drugs and treatments.
As most Senators know, my wife has been ill with cancer. She had 20 weeks of chemotherapy, and every week we worried the drug wouldn’t be there on Monday morning at noon, when she went for treatment.
Fortunately for us, it was always available. But that isn’t always the case.
These shortages threaten public health, and prevent patients from getting the care they need.
Shortages of one drug used to treat a rare form of childhood leukemia – a drug that is an effective cure in 90 percent of cases – have literally put young lives at risk.
No mother or father should have to watch a child suffers as he waits for life-saving medicine.
But as the number of drug shortages increases each year, more parents wait and worry.
In 2005, the FDA reported shortages of 55 medications.
Last year, the number jumped to 231 – including the leukemia drug I just mentioned and some chemotherapy medicines.
These shortages are caused by a variety of factors – problems at factories, limited manufacturing capacity or lack of raw materials.
Some are even caused by lack of financial incentive – profit motive – for companies to manufacture enough of certain medicines.
Public awareness and pressure have prompted drug makers to voluntarily notify the FDA of many impending shortages – preventing almost 200 more shortages last year alone.
But Congress can and must do more to improve communication between drug makers, the FDA and hospitals that provide crucial care.
Passing this legislation without delay will be a leap forward in that process.