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	<title>Senate Democrats &#187; FDA</title>
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	<link>http://democrats.senate.gov</link>
	<description>Official news and legislative information from Democrats in the U.S. Senate.</description>
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		<title>Reid: Republicans Deny War On Women, Then Oppose Legislation To Help Women Achieve Equal Pay For Equal Work</title>
		<link>http://democrats.senate.gov/2012/05/24/reid-republicans-deny-war-on-women-then-oppose-legislation-to-help-women-achieve-equal-pay-for-equal-work/</link>
		<comments>http://democrats.senate.gov/2012/05/24/reid-republicans-deny-war-on-women-then-oppose-legislation-to-help-women-achieve-equal-pay-for-equal-work/#comments</comments>
		<pubDate>Thu, 24 May 2012 14:12:03 +0000</pubDate>
		<dc:creator>aaron</dc:creator>
				<category><![CDATA[News]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[gender equality]]></category>
		<category><![CDATA[Republicans]]></category>

		<guid isPermaLink="false">http://democrats.senate.gov/?p=109188</guid>
		<description><![CDATA[Washington, D.C. – Nevada Senator Harry Reid spoke on the Senate floor today regarding the bipartisan efforts to pass the Food and Drug Administration Safety and Innovation Act and a temporary renewal of the flood insurance program. Below are his remarks as prepared for delivery: I was pleased yesterday to reach an agreement with the&#8230;]]></description>
				<content:encoded><![CDATA[<p><strong>Washington, D.C. –</strong> <em>Nevada Senator Harry Reid spoke on the Senate floor today regarding the bipartisan efforts to pass the Food and Drug Administration Safety and Innovation Act and a temporary renewal of the flood insurance program. Below are his remarks as prepared for delivery:</em></p>
<p>I was pleased yesterday to reach an agreement with the Republican Leader to move forward with passage of the Food and Drug Administration Safety and Innovation Act.</p>
<p>This legislation will ease shortages of life-saving medicines by establishing effective lines of communication between drug makers and the FDA.</p>
<p>And it will ensure the FDA has the resources to approve new drugs and medical devices quickly and efficiently.</p>
<p>We will consider a reasonable number of relevant amendments from both sides. And I am optimistic that this crucial legislation will be passed on a strong, bipartisan vote.</p>
<p>This week has been a productive one. Democrats weren’t forced to break even one Republican filibuster.</p>
<p>I hope this trend continues, and we see a return to the time when reasonable lawmakers from each party could work together to advance important legislation.</p>
<p>I am also hopeful this week the Senate will be able to find a path ahead to temporarily renew the flood insurance program.</p>
<p>I am committed to bringing a long-term solution with limited amendment votes to the floor next work period. The 6 million Americans affected by this program deserve the certainty long-term legislation will provide.</p>
<p>The collaborative work on this measure and on the FDA bill renew my hope that Congress will also reach a bipartisan agreement to prevent student loan interest rates from doubling for 7 million young men and women.</p>
<p>We will vote this afternoon on two proposals to freeze students’ interest rates at their current levels.</p>
<p>The Republican proposal is paid for by stripping Americans of life-saving preventive healthcare.</p>
<p>The Democratic proposal is paid for by closing a loophole that allows wealthy Americans to dodge their taxes.</p>
<p>It’s easy to see these two proposals were not created equal.</p>
<p>I hope a few reasonable Republicans will join Democrats in voting for a student loan bill that doesn’t put Americans’ health at risk. But it seems possible Republicans will block our reasonable proposal for a second time.</p>
<p>If that’s the case, American students should know Democrats will not relent until Congress has taken action against the skyrocketing price of higher education.</p>
<p>I hope to resolve that issue and many others next work period, when the Senate once again faces a hefty list of must-do tasks.</p>
<p>In addition to a farm bill, flood insurance legislation, small business tax relief and a cyber security measure, the Senate will vote on the Paycheck Fairness Act.</p>
<p>Last Congress, we passed the Lilly Ledbetter Fair Pay Act. It was the single greatest legislative step to ensure women have every chance to be full, equal participants in the workforce since the Equal Pay Act of 1963.</p>
<p>But while the wage gap has narrowed in the five decades since Congress declared women entitled to equal pay for equal work, gender discrimination remains a serious problem in the workplace.</p>
<p>Although women make up nearly half of today’s workforce, they still earn only 77 cents on the dollar compared to their male colleagues.</p>
<p>And with an increasing number of women heading American households, this is a problem that affects children and families across the country.</p>
<p>The Paycheck Fairness Act is a logical extension of protections under the Equal Pay Act. It will help close the pay gap by empowering women to negotiate for equal pay and creating strong incentives for employers to obey the laws already in place.</p>
<p>Republicans deny they’re waging a war on women, yet they’ve launched a series of attacks on women’s access to health care and contraception this year.</p>
<p>Now they have an opportunity to back up their excuses with action.</p>
<p>I hope they take that opportunity, and join Democrats as we send a clear message that America values the incredible contributions women make every day.</p>
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		<title>Reid: FDA Bill Will Help Prevent Drug Shortages, Save Lives</title>
		<link>http://democrats.senate.gov/2012/05/23/reid-fda-bill-will-help-prevent-drug-shortages-save-lives/</link>
		<comments>http://democrats.senate.gov/2012/05/23/reid-fda-bill-will-help-prevent-drug-shortages-save-lives/#comments</comments>
		<pubDate>Wed, 23 May 2012 14:21:08 +0000</pubDate>
		<dc:creator>aaron</dc:creator>
				<category><![CDATA[News]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[prescription drugs]]></category>

		<guid isPermaLink="false">http://democrats.senate.gov/?p=109145</guid>
		<description><![CDATA[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&#8230;]]></description>
				<content:encoded><![CDATA[<p><strong>Washington, D.C. </strong>–<em> 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:</em></p>
<p>When 67-year-old Pamela Gunter began treatment for breast cancer, her doctor knew it would be a grueling fight.</p>
<p>He also knew it was a fight Pamela could win.</p>
<p>Pamela’s doctor put her on Taxol, a common chemotherapy drug.</p>
<p>The results were excellent: her tumors shrank.</p>
<p>Her prognosis was good.</p>
<p>Then – one day last spring – the Taxol ran out.</p>
<p>One of the most popular and effective treatments for breast, lung and ovarian cancer had suddenly disappeared from the market.</p>
<p>Doctors couldn’t get it. And drug suppliers couldn’t say why.</p>
<p>So Pamela’s doctor was forced use a much more expensive and much less effective course of treatment.</p>
<p>Her cancer spread.</p>
<p>By the time Taxol was available again, it was too late.</p>
<p>Pamela died in November.</p>
<p>She left behind a loving husband. She left behind two grown sons. She left behind a one-year-old grandson.</p>
<p>But with the right treatment, Pamela would still be alive today.</p>
<p>Her Las Vegas doctor says a shortage of this common, generic medicine directly contributed to her death.</p>
<p>Pamela isn’t the only American affected by shortages of Taxol and other life-saving drugs.</p>
<p>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.</p>
<p>Today, Taxol is still scarce. And chemotherapy drugs aren’t the only ones in short supply.</p>
<p>Supplies of nausea medications and other drugs that reduce the side effects of cancer treatment are also limited.</p>
<p>On Monday, a Las Vegas oncologist said he ordered 10 drugs from his supplier. Only eight were available.</p>
<p>That’s typical. Doctors never know which drugs will be accessible and which won’t.</p>
<p>Last year, the FDA reported shortages of 231 drugs – including several chemotherapy medicines.</p>
<p>In the last six years, drug shortages have quadrupled.</p>
<p>Now, Congress can’t solve every problem in this country. But this is one problem we can solve, with cooperation from drug manufacturers.</p>
<p>The Food and Drug Administration Safety and Innovation Act will help establish effective lines of communication between drug makers, the FDA and doctors.</p>
<p>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.</p>
<p>Drug makers averted 200 shortages last year alone by voluntarily notifying the FDA of trouble on the horizon.</p>
<p>But many more shortages – perhaps all 231 last year – could have been prevented if every drug maker shared information with the FDA.</p>
<p>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.</p>
<p>Passing this legislation won’t bring Pamela back.</p>
<p>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.</p>
<p>But this legislation will help prevent drug shortages like the one that took Pamela away from her family far too soon.</p>
]]></content:encoded>
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		<title>Reid: Bill To Enable Better Communication Between Manufacturers, FDA Will Prevent Drug Shortages And Save Lives</title>
		<link>http://democrats.senate.gov/2012/05/22/reid-bill-to-enable-better-communication-between-manufacturers-fda-will-prevent-drug-shortages-and-save-lives/</link>
		<comments>http://democrats.senate.gov/2012/05/22/reid-bill-to-enable-better-communication-between-manufacturers-fda-will-prevent-drug-shortages-and-save-lives/#comments</comments>
		<pubDate>Tue, 22 May 2012 16:25:51 +0000</pubDate>
		<dc:creator>aaron</dc:creator>
				<category><![CDATA[News]]></category>
		<category><![CDATA[FDA]]></category>

		<guid isPermaLink="false">http://democrats.senate.gov/?p=109103</guid>
		<description><![CDATA[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: Twelve million people in the United States today have faced a cancer diagnosis. Many have fought back against this terrible disease and won.&#8230;]]></description>
				<content:encoded><![CDATA[<p><strong>Washington, D.C.</strong> – <em>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:</em></p>
<p>Twelve million people in the United States today have faced a cancer diagnosis.</p>
<p>Many have fought back against this terrible disease and won. Others are still fighting today.</p>
<p>And each one of them knows just how difficult a cancer diagnosis can be.</p>
<p>But imagine coming to terms with your diagnosis only to find out the life-saving drug you need to survive is in short supply – or simply not available.</p>
<p>That’s the situation faced by many Americans battling cancer and other life-threatening illnesses.</p>
<p>Through 20 weeks of chemotherapy, my wife and I lived with the fear that the medicine she needed every Monday morning wouldn’t be available when we got to the doctor’s office.</p>
<p>We were fortunate – the drug was always accessible. But many Americans haven’t been so lucky.</p>
<p>One Nevadan fighting bladder cancer was near the end of treatment when the medicine he was taking suddenly ran short.</p>
<p>Only time will tell whether the treatment he received was enough to save his life.</p>
<p>Another Nevada woman with bowel cancer was forced to choose a less effective chemotherapy treatment because the best drug on the market – one that cures bowel cancer in 75 percent of cases – wasn’t available.</p>
<p>Only time will tell whether the second-choice medicine was effective enough.</p>
<p>Yet another Nevada man was relying on two cancer drugs to keep him alive longer and give him greater quality of life – but one drug was in short supply. Since the drugs only work when taken together, doctors have only been able to treat him intermittently.</p>
<p>Only time will tell how many days or weeks he lost because he couldn’t get the drug he needed.</p>
<p>Every day, these stories play out in hospitals across the country.</p>
<p>Every day, Americans experience shortages of life-saving, FDA-approved drugs and treatments.</p>
<p>These shortages literally put American lives at risk.</p>
<p>And as the number of shortages increases each year, more patients are forced to wait for treatment and worry.</p>
<p>In the last six years, drug shortages have quadrupled.</p>
<p>Last year, the FDA reported shortages of 231 drugs – including many chemotherapy medicines.</p>
<p>Public pressure has prompted some drug makers to voluntarily notify the FDA of impending shortages.</p>
<p>But Congress must step in to improve communication between drug makers, the FDA and doctors – doctors who have to break the terrible news that life-saving medicines aren’t available.</p>
<p>Voluntary cooperation between drug makers and the FDA prevented almost 200 drug shortages last year.</p>
<p>But establishing effective lines of communication could further reduce the number of shortages, and save patients’ lives.</p>
<p>So I am pleased the spirit of bipartisanship – begun by my colleagues, Senator Harkin and Senator Enzi – continued yesterday.</p>
<p>I look forward to an orderly amendment process. And I am optimistic that the Senate will move this legislation without unnecessary delays.</p>
<p>Each year, more than 1.5 million Americans are diagnosed with some form of cancer.</p>
<p>It is up to us to ensure not one of them waits and wonders if the medicine he needs to stay alive will be there when he needs it.</p>
]]></content:encoded>
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		<title>Reid: Republican Obstruction, Infighting Threaten More Bipartisan Legislation</title>
		<link>http://democrats.senate.gov/2012/05/21/reid-republican-obstruction-infighting-threaten-more-bipartisan-legislation/</link>
		<comments>http://democrats.senate.gov/2012/05/21/reid-republican-obstruction-infighting-threaten-more-bipartisan-legislation/#comments</comments>
		<pubDate>Mon, 21 May 2012 19:37:25 +0000</pubDate>
		<dc:creator>aaron</dc:creator>
				<category><![CDATA[News]]></category>
		<category><![CDATA[bipartisanship]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Iran]]></category>
		<category><![CDATA[Republicans]]></category>
		<category><![CDATA[VAWA]]></category>
		<category><![CDATA[Violence Against Women Act]]></category>

		<guid isPermaLink="false">http://democrats.senate.gov/?p=109004</guid>
		<description><![CDATA[Washington, D.C. – Nevada Senator Harry Reid spoke on the Senate floor today regarding Republican obstruction of Iran sanctions, a student loan bill, the Violence Against Women Act and a bill to reform the FDA. Below are his remarks as prepared for delivery: This week the Senate must complete work on legislation to enact crucial&#8230;]]></description>
				<content:encoded><![CDATA[<p><strong>Washington, D.C.</strong> – <em>Nevada Senator Harry Reid spoke on the Senate floor today regarding Republican obstruction of Iran sanctions, a student loan bill, the Violence Against Women Act and a bill to reform the FDA. Below are his remarks as prepared for delivery:</em></p>
<p>This week the Senate must complete work on legislation to enact crucial reforms that will prevent drug shortages and bring life-saving medicines to market more quickly.</p>
<p>Senator Harkin and Senator Enzi – a Democrat and a Republican – worked very hard to bring this legislation to the floor.</p>
<p>I am cautiously optimistic that spirit of bipartisan collaboration continues – because Democrats can&#8217;t pass this legislation without the cooperation of our Republican colleagues.</p>
<p>I certainly hope they will allow us to advance this bill this evening without the additional delay of another filibuster.</p>
<p>I would like Senators from both parties to be free to offer relevant amendments to improve a worthy bill.</p>
<p>But before we can get to work on this legislation in earnest, my Republican colleagues must stop their filibuster.</p>
<p>Americans living with cancer and other life-threatening illnesses are watching closely to see whether the Senate is capable of quick action to ease shortages of crucial medicines – or whether we will once more be paralyzed by Republican obstruction.</p>
<p><strong>Student Loans</strong></p>
<p>Americans have seen that obstruction time and again this Congress.</p>
<p>They are frustrated with the slow pace of Senate action to reauthorize the Violence Against Women Act, on Iran sanctions and on legislation to stop interest rates from doubling on federal student loans.</p>
<p>Earlier this month, Republicans blocked one attempt to keep higher education affordable for 7 million students.</p>
<p>But Democrats haven&#8217;t given up. I only hope our Republican colleagues will come to their senses and allow us to prevent this crisis before it&#8217;s too late.</p>
<p><strong>Iran Sanctions</strong></p>
<p>Republican obstruction and infighting have also stalled critical new sanctions against Iran.</p>
<p>For two months, Democrats have worked to resolve Republican objections to this bipartisan measure, which passed out of the Banking Committee unanimously.</p>
<p>The stakes couldn’t be higher. Sanctions are a key tool to stop Iran from obtaining a nuclear weapon, threatening Israel and jeopardizing U.S. national security.</p>
<p>We cannot afford any more delays to putting stronger sanctions in place.</p>
<p>I am hopeful my Republican colleagues will realize how important it is to advance these measures and prevent Iran from obtaining a nuclear weapon.</p>
<p><strong>Violence Against Women</strong></p>
<p>Republicans have also needlessly blocked progress on reauthorization of the Violence Against Women Act. This helps law enforcement effectively combat and prosecute domestic crimes against women.</p>
<p>Although both Chambers have passed a version of this legislation, House Republicans have refused to go to conference with the Senate.</p>
<p>Their excuse – a hyper-technical budget issue called a blue slip – isn’t much of a fig leaf to hide their blatant obstruction.</p>
<p>The truth is Republicans are looking for any excuse to stall or kill this worthy legislation. And American women aren&#8217;t fooled.</p>
<p>If Republicans really want to give police the tools they need to prosecute domestic abusers, they will drop the facade.</p>
<p>If Republicans really care about protecting women and families, they will abandon their hyper-technical objections and join us in conference. The differences between the House and Senate-passed bills could be worked out easily.</p>
<p>American women and families are counting on our action.</p>
<p><strong>Inaction</strong></p>
<p>But this Congress Republicans have been more interested in inaction than in getting things done.</p>
<p>They&#8217;re more interested in blocking worthy legislation for partisan gain than in working together.</p>
<p>Their infighting and partisan games have stopped reauthorization of the Violence Against Women Act, Iran sanctions and the student loan fix in their tracks.</p>
<p>The FDA bill – which will prevent drug shortages and making life-saving medicines available more quickly – must not become another victim of their partisanship.</p>
<p>I hope Republicans seize this opportunity to be cooperative rather than combative.</p>
]]></content:encoded>
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		<title>Reid: Bipartisan FDA Bill Will Ease Drug Shortages And Speed Life-Saving Medicines To Market</title>
		<link>http://democrats.senate.gov/2012/05/17/reid-bipartisan-fda-bill-will-ease-drug-shortages-and-speed-life-saving-medicines-to-market/</link>
		<comments>http://democrats.senate.gov/2012/05/17/reid-bipartisan-fda-bill-will-ease-drug-shortages-and-speed-life-saving-medicines-to-market/#comments</comments>
		<pubDate>Thu, 17 May 2012 15:22:40 +0000</pubDate>
		<dc:creator>aaron</dc:creator>
				<category><![CDATA[News]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[health care]]></category>
		<category><![CDATA[prescription drugs]]></category>

		<guid isPermaLink="false">http://democrats.senate.gov/?p=108966</guid>
		<description><![CDATA[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&#8230;]]></description>
				<content:encoded><![CDATA[<p><strong>Washington, D.C.</strong> – <em>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:</em></p>
<p>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.</p>
<p>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.</p>
<p>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.</p>
<p>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.</p>
<p>I applaud the work of my colleagues, Senator Harkin and Senator Enzi, to bring this legislation to the floor.</p>
<p>I hope to see the strong, bipartisan effort these two senators began continue as the Senate considers this important measure.</p>
<p>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.</p>
<p>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.</p>
<p>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.</p>
<p>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.</p>
<p>It will help spur the innovations that bring the next groundbreaking cancer or Parkinson’s drug to market.</p>
<p>The bill will hold foreign manufacturer who sell drugs in United States to the same high standards met by American companies.</p>
<p>And it will help prevent drug shortages by opening up the lines of communication between manufacturers and the FDA.</p>
<p>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.</p>
<p>Every day, hospitals across the country experience shortages of life-saving, FDA-approved drugs and treatments.</p>
<p>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.</p>
<p>Fortunately for us, it was always available. But that isn’t always the case.</p>
<p>These shortages threaten public health, and prevent patients from getting the care they need.</p>
<p>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.</p>
<p>No mother or father should have to watch a child suffers as he waits for life-saving medicine.</p>
<p>But as the number of drug shortages increases each year, more parents wait and worry.</p>
<p>In 2005, the FDA reported shortages of 55 medications.</p>
<p>Last year, the number jumped to 231 – including the leukemia drug I just mentioned and some chemotherapy medicines.</p>
<p>These shortages are caused by a variety of factors – problems at factories, limited manufacturing capacity or lack of raw materials.</p>
<p>Some are even caused by lack of financial incentive – profit motive – for companies to manufacture enough of certain medicines.</p>
<p>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.</p>
<p>But Congress can and must do more to improve communication between drug makers, the FDA and hospitals that provide crucial care.</p>
<p>Passing this legislation without delay will be a leap forward in that process.</p>
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