Reid: FDA Bill Will Help Prevent Drug Shortages, Save Lives
May 23, 2012
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Washington, D.C. – Nevada Senator Harry Reid spoke on the Senate floor today regarding legislation to help the FDA prevent shortages of life-saving medicines. Below are his remarks as prepared for delivery:
When 67-year-old Pamela Gunter began treatment for breast cancer, her doctor knew it would be a grueling fight.
He also knew it was a fight Pamela could win.
Pamela’s doctor put her on Taxol, a common chemotherapy drug.
The results were excellent: her tumors shrank.
Her prognosis was good.
Then – one day last spring – the Taxol ran out.
One of the most popular and effective treatments for breast, lung and ovarian cancer had suddenly disappeared from the market.
Doctors couldn’t get it. And drug suppliers couldn’t say why.
So Pamela’s doctor was forced use a much more expensive and much less effective course of treatment.
Her cancer spread.
By the time Taxol was available again, it was too late.
Pamela died in November.
She left behind a loving husband. She left behind two grown sons. She left behind a one-year-old grandson.
But with the right treatment, Pamela would still be alive today.
Her Las Vegas doctor says a shortage of this common, generic medicine directly contributed to her death.
Pamela isn’t the only American affected by shortages of Taxol and other life-saving drugs.
Every day, in hospitals across the country, Americans already dealing with devastating illnesses must also face shortages of FDA-approved medications that could keep them alive.
Today, Taxol is still scarce. And chemotherapy drugs aren’t the only ones in short supply.
Supplies of nausea medications and other drugs that reduce the side effects of cancer treatment are also limited.
On Monday, a Las Vegas oncologist said he ordered 10 drugs from his supplier. Only eight were available.
That’s typical. Doctors never know which drugs will be accessible and which won’t.
Last year, the FDA reported shortages of 231 drugs – including several chemotherapy medicines.
In the last six years, drug shortages have quadrupled.
Now, Congress can’t solve every problem in this country. But this is one problem we can solve, with cooperation from drug manufacturers.
The Food and Drug Administration Safety and Innovation Act will help establish effective lines of communication between drug makers, the FDA and doctors.
When the FDA gets early warning from manufacturers that shortages are coming, it can act quickly to find alternate sources of medication and ease supply problems.
Drug makers averted 200 shortages last year alone by voluntarily notifying the FDA of trouble on the horizon.
But many more shortages – perhaps all 231 last year – could have been prevented if every drug maker shared information with the FDA.
That’s why Congress must act quickly to pass this legislation, which will also ensure the FDA has the resources to approve new drugs and medical devices quickly and efficiently.
Passing this legislation won’t bring Pamela back.
It won’t give her another day to spend with her husband, another week to say goodbye to her sons or another year to get to know her grandchild.
But this legislation will help prevent drug shortages like the one that took Pamela away from her family far too soon.