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Monthly Archives: October 2011
The number of prescription drug shortages tripled between 2005 and 2010. Besides having serious consequences for people's health and well-being, drug shortages drive vendors to charge outragous prices for drugs that are normally affordable when in stock. One report found that price-gouging vendors mark up prices on drugs in short supply by 650 percent, on average.
Another report about these “grey market vendors”—companies that inflate prices of drugs running in short supply—found that a leukemia drug whose typical contract price is about $12 per vial was being sold at $990 per vial. At the extreme, a drug used to treat high blood pressure that was normally priced at $25.90 was being sold at $1,200 due to a drug shortage.
Only a very small number of drugs are affected by such shortages, but for many patients, changing medications may be the difference between getting healthier and getting sicker. Drugs affected by shortages include cancer treatments, anesthesia drugs, and other medications that are critical to the treatment and prevention of serious diseases and life-threatening conditions.
Today, President Obama signed an Executive Order that will help prevent shortages that lead to this type of price gouging. The order directs the Food and Drug Administration to expand reporting about situations that might lead to drug shortages, and also to work with the Department of Justice to investigate illegal price gouging.
For Immediate Release
TO MODIFY THE HARMONIZED TARIFF SCHEDULE OF THE UNITED STATES
BY THE PRESIDENT OF THE UNITED STATES OF AMERICA
1. Section 1205(a) of the Omnibus Trade and Competitiveness Act of 1988 (the "1988 Act") (19 U.S.C. 3005(a)) directs the United States International Trade Commission (the "Commission") to keep the Harmonized Tariff Schedule of the United States (HTS) under continuous review and periodically to recommend to the President such modifications to the HTS as the Commission considers necessary or appropriate to accomplish the purposes set forth in that subsection. Among those purposes are to promote the uniform application of the International Convention on the Harmonized Commodity Description and Coding System (the "Convention") and to alleviate unnecessary administrative burdens.
2. The Commission conducted an investigation pursuant to section 1205 of the 1988 Act (Investigation No. 1205-8) in response to a request from the Department of the Treasury regarding certain footwear featuring outer soles of rubber or plastic to which a layer of textile material has been added. The request stated that changes to the HTS would promote the uniform application of the Convention as well as alleviate unnecessary administrative burdens.
3. On August 9, 2010, the Commission issued a report in Investigation No. 1205-8, recommending certain changes to the HTS. The report and layover requirements of section 1206(b) of the 1988 Act (19 U.S.C. 3006(b)) were satisfied as of March 30, 2011.
4. On November 8, 2010, the United States Trade Representative (the "USTR") requested that the Commission make further recommendations consistent with section 1205(d) of the 1988 Act concerning particular provisions of the HTS that the Commission had recommended in its August report be replaced by new tariff lines. The USTR also asked the Commission to consider whether, in response to requests made by interested parties in the course of the original investigation, additional tariff lines should be inserted in the HTS.
5. On February 18, 2011, the Commission issued an addendum to its report, recommending additional modifications to the HTS. The report and layover requirements of section 1206(b) were satisfied as of June 30, 2011.
6. Section 1206(a) of the 1988 Act (19 U.S.C. 3006(a)) authorizes the President to proclaim modifications to the HTS based on recommendations made by the Commission pursuant to section 1205 of the 1988 Act, if he determines that the modifications are in conformity with United States obligations under the Convention and do not run counter to the national economic interest of the United States. I have determined that the modifications to the HTS set forth in Annex I to this proclamation are in conformity with United States obligations under the Convention and do not run counter to the national economic interest of the United States.
7. On June 6, 2003, the United States and Chile entered into the United States-Chile Free Trade Agreement (USCFTA). The Congress approved the USCFTA in section 101(a) of the United States-Chile Free Trade Agreement Implementation Act (the "USCFTA Act") (19 U.S.C. 3805 note). Presidential Proclamation 7746 of December 30, 2003, implemented the USCFTA with respect to the United States, and incorporated in the HTS the tariff modifications and rules of origin necessary or appropriate to carry out the USCFTA.
8. Section 202 of the USCFTA Act provides rules for determining whether goods imported into the United States originate in the territory of a USCFTA Party and thus are eligible for the tariff and other treatment contemplated under the USCFTA. Section 202(o)(2)(A) authorizes the President to proclaim, subject to the consultation and layover requirements of section 103(a) of the USCFTA Act, modifications to such previously proclaimed rules of origin.
9. The United States and Chile have agreed to modify certain rules of origin and to add certain other rules of origin in the USCFTA. I have determined that further modification of the USCFTA rules of origin set forth in Proclamation 7746, and subsequently modified, is therefore necessary.
10. The consultation and layover requirements of section 103(a) of the USCFTA Act were satisfied as of July 10, 2010.
11. On April 15, 1994, the United States entered into trade agreements resulting from the Uruguay Round of multilateral trade negotiations (the "Uruguay Round Agreements"). In section 101(a) of the Uruguay Round Agreements Act (the "URAA") (19 U.S.C. 3511(a)), the Congress approved the Uruguay Round Agreements listed in section 101(d) of that Act, including the Agreement on Agriculture in section 101(d)(2). To implement section 4.2 of the Agreement on Agriculture, section 401(b)(2) of the URAA amended section 103B of the Agricultural Act of 1949 (7 U.S.C. 1444-2) by converting the special import quotas on cotton provided for under section 103B to tariff-rate quotas.
12. Proclamation 6301 of June 7, 1991, and Proclamation 6948 of October 29, 1996, modified U.S. note 6 to subchapter III of chapter 99 of the HTS and created tariff lines in the HTS for reporting entries under a special import quota for upland cotton. Note 6 sets out the conditions under which a special import quota for upland cotton takes effect.
13. Section 1207(a)(2)(B) of the Food Conservation and Energy Act of 2008 (7 U.S.C. 8737(a)(2)(B)) changed the conditions under which a special import quota for upland cotton takes effect. U.S. note 6 to subchapter III of chapter 99 needs to be modified to reflect those changes.
14. Section 604 of the Trade Act of 1974, as amended (the "Trade Act") (19 U.S.C. 2483), authorizes the President to embody in the HTS the substance of the relevant provisions of that Act, and of other Acts, affecting import treatment, and actions thereunder, including the removal, modification, continuance, or imposition of any rate of duty or other import restriction.
NOW, THEREFORE, I, BARACK OBAMA, President of the United States of America, by virtue of the authority vested in me by the Constitution and the laws of the United States of America, including but not limited to section 1206 of the 1988 Act, section 202 of the USCFTA Act, and section 604 of the Trade Act, do proclaim that:
(1) In order to modify the HTS to promote the uniform application of the Convention and to alleviate unnecessary administrative burdens, the HTS is modified as set forth in Annex I to this proclamation.
(2) The modifications to the HTS set forth in Annex I to this proclamation shall be effective with respect to goods that are entered, or withdrawn from warehouse for consumption, on or after the later of September 1, 2011, or the thirtieth day after publication of this proclamation in the Federal Register.
(3) In order to modify the rules of origin under the USCFTA, general note 26 to the HTS is modified as provided in Annex II to this proclamation.
(4) The modifications made by Annex II to this proclamation shall be effective with respect to goods of Chile under the terms of general note 26 to the HTS that are entered, or withdrawn from warehouse for consumption, on or after November 1, 2011.
(5) In order to reflect the modified requirements under which a special import quota for upland cotton takes effect, the HTS is modified as set forth in Annex III to this proclamation.
(6) The modifications made by Annex III to this proclamation, shall be effective with respect to goods entered, or withdrawn from warehouse for consumption, on or after June 18, 2008.
(7) Any provisions of previous proclamations and Executive Orders that are inconsistent with the actions taken in this proclamation are superseded to the extent of such inconsistency.
IN WITNESS WHEREOF, I have hereunto set my hand this thirty-first day of October, in the year of our Lord two thousand eleven, and of the Independence of the United States of America the two hundred and thirty-sixth.
Sometimes the most important component of a patient’s treatment is the type of medication they receive and the consistency at which they receive it. For some Americans, a change in their treatment regimen or a substitution of a medication can seriously threaten their ability to get better.
Between 2005 and 2010, the number of prescription drug shortages nearly tripled. While the FDA successfully prevented 137 drug shortages between January 1, 2010 and September 26, 2011, prescription drug shortages continue to threaten the health and safety of the American people. Today, too many people are waiting for their prescription to become available. Some are forced to switch from the medication they prefer, while others go without their medicine altogether. In some cases, drug shortages can even force people to stop a course of treatment before it finishes.
We cannot control the factors that cause these drug shortages. But we are committed to doing our part to counteract them. Which is why President Obama signed an Executive Order today that will lead to earlier FDA notification of any impending shortages for certain prescription drugs. Early notification can help prevent a shortage from becoming a crisis by allowing hospitals, doctors and manufacturers to take action to ensure medications remain available.
In addition, the President’s Executive Order will call on FDA to work with the Justice Department to examine whether “gray market” profiteers are responding to potential drug shortages either by hoarding medications or charging exorbitant prices. In recent months, we’ve heard reports of enormous markups such as a blood pressure medicine usually priced at $26 being sold for $1,200. And under this Executive Order, the Justice Department will watch the market closely to make sure companies are not exploiting drug shortages to raise their profits at the expense of patients.
For Immediate Release
REDUCING PRESCRIPTION DRUG SHORTAGES
By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:
Section 1. Policy. Shortages of pharmaceutical drugs pose a serious and growing threat to public health. While a very small number of drugs in the United States experience a shortage in any given year, the number of prescription drug shortages in the United States nearly tripled between 2005 and 2010, and shortages are becoming more severe as well as more frequent. The affected medicines include cancer treatments, anesthesia drugs, and other drugs that are critical to the treatment and prevention of serious diseases and life threatening conditions.
For example, over approximately the last 5 years, data indicates that the use of sterile injectable cancer treatments has increased by about 20 percent, without a corresponding increase in production capacity. While manufacturers are currently in the process of expanding capacity, it may be several years before production capacity has been significantly increased. Interruptions in the supplies of these drugs endanger patient safety and burden doctors, hospitals, pharmacists, and patients. They also increase health care costs, particularly because some participants in the market may use shortages as opportunities to hoard scarce drugs or charge exorbitant prices.
The Food and Drug Administration (FDA) in the Department of Health and Human Services has been working diligently to address this problem through its existing regulatory framework. While the root problems and many of their solutions are outside of the FDA's control, the agency has worked cooperatively with manufacturers to prevent or mitigate shortages by expediting review of certain regulatory submissions and adopting a flexible approach to drug manufacturing and importation regulations where appropriate. As a result, the FDA prevented 137 drug shortages in 2010 and 2011. Despite these successes, however, the problem of drug shortages has continued to grow.
Many different factors contribute to drug shortages, and solving this critical public health problem will require a multifaceted approach. An important factor in many of the recent shortages appears to be an increase in demand that exceeds current manufacturing capacity. While manufacturers are in the process of expanding capacity, one important step is ensuring that the FDA and the public receive adequate advance notice of shortages whenever possible. The FDA cannot begin to work with manufacturers or use the other tools at its disposal until it knows there is a potential problem. Similarly, early disclosure of a shortage can help hospitals, doctors, and patients make alternative arrangements before a shortage becomes a crisis. However, drug manufacturers have not consistently provided the FDA with adequate notice of potential shortages.
As part of my Administration's broader effort to work with manufacturers, health care providers, and other stakeholders to prevent drug shortages, this order directs the FDA to take steps that will help to prevent and reduce current and future disruptions in the supply of lifesaving medicines.
Sec. 2. Broader Reporting of Manufacturing Discontinuances. To the extent permitted by law, the FDA shall use all appropriate administrative tools, including its authority to interpret and administer the reporting requirements in 21 U.S.C. 356c, to require drug manufacturers to provide adequate advance notice of manufacturing discontinuances that could lead to shortages of drugs that are life supporting or life sustaining, or that prevent debilitating disease.
Sec. 3. Expedited Regulatory Review. To the extent practicable, and consistent with its statutory responsibility to ensure the safety and effectiveness of the drug supply, the FDA shall take steps to expand its current efforts to expedite its regulatory reviews, including reviews of new drug suppliers, manufacturing sites, and manufacturing changes, whenever it determines that expedited review would help to avoid or mitigate existing or potential drug shortages. In prioritizing and allocating its limited resources, the FDA should consider both the severity of the shortage and the importance of the affected drug to public health.
Sec. 4. Review of Certain Behaviors by Market Participants. The FDA shall communicate to the Department of Justice (DOJ) any findings that shortages have led market participants to stockpile the affected drugs or sell them at exorbitant prices. The DOJ shall then determine whether these activities are consistent with applicable law. Based on its determination, DOJ, in coordination with other State and Federal regulatory agencies as appropriate, should undertake whatever enforcement actions, if any, it deems appropriate.
Sec. 5. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect:
(i) authority granted by law to an agency, or the head thereof; or
(ii) functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
THE WHITE HOUSE,
October 31, 2011.
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For Immediate Release
While the Food and Drug Administration has successfully prevented 137 drug shortages since the beginning of 2010, drug shortages have been increasing in frequency and severity in recent years and adversely affecting patient care. A small number of drugs in the U.S. experience a shortage in any given year, but the number of reported prescription drug shortages in the United States nearly tripled between 2005 and 2010, going from 61 to 178. There are many causes and potential solutions to this challenge and addressing this significant public health problem will require the urgent attention of industry, other stakeholders, and government.
Today, President Obama will issue an Executive Order directing the FDA and Department of Justice to take action to help further reduce and prevent drug shortages, protect consumers, and prevent price gouging. These additional steps for early notification will help achieve some of the goals of bipartisan legislation in Congress, which the President supports, that will strengthen the FDA’s ability to prevent prescription drug shortages in the future.
The Executive Order is one in a series of steps that will help address the shortage of prescription drugs and ensure patients have access to the lifesaving medicines they need. Today, the Obama Administration will also:
- Send a letter to drug manufacturers reminding them of their legal responsibility to report the discontinuation of certain drugs to the FDA. The letter also encourages companies to voluntarily notify FDA about potential prescription drug shortages in cases where notification is not currently required.
- Increase staffing resources for the FDA’s Drug Shortages Program to address the increased workload that will result from additional early notification of potential shortages by manufacturers.
- Release a report from the Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation (ASPE) that assesses the underlying factors that lead to drug shortages, and an FDA report on its role in monitoring, preventing, and responding to these shortages.
President Obama’s Executive Order
Early notification of potential drug shortages can help FDA work with drug manufacturers, hospitals, doctors, and patients to prevent or mitigate a shortage before it becomes a crisis. Currently, Federal law requires drug manufacturers to notify FDA when production of critical drugs provided by only one manufacturer is being discontinued. The President’s order directs FDA to broaden reporting of potential shortages of certain prescription drugs. Additionally, the Executive Order requires FDA to expand its current efforts to expedite review of new manufacturing sites, drug suppliers, and manufacturing changes to help prevent shortages.
While additional manufacturing capacity is necessary to fully address the drug shortage problem, early disclosure can have a significant, positive impact on the incidence and duration of drug shortages. This year alone, voluntary early notification by manufacturers allowed FDA to successfully prevent 99 drug shortages. Once FDA is notified of an existing shortage, the agency has multiple options to prevent or mitigate the drug shortage, and in many cases, takes more than one action. In the shortages studied, the agency’s three most common actions were:
- Asking other firms to increase production (31%),
- Working with manufacturers to identify ways to mitigate quality issues, i.e. flexibility through regulatory discretion (28%), and
- Expediting review of regulatory submissions (26%).
FDA has also exercised regulatory discretion regarding controlled importation of similar products approved abroad but not approved in the United States in 5 percent of cases.
Fighting Price Gouging
The President’s Executive Order also directs FDA to work with the Department of Justice to examine whether any secondary drug wholesalers or other market participants have responded to potential drug shortages by illegally hoarding medications or raising prices to gouge consumers. For example, the ranking member of the House Committee on Oversight and Government Reforms, when announcing his investigation into so-called gray markets, expressed concerns about a report that a leukemia drug whose typical contract price is about $12 per vial was being sold at $990 per vial – 80 times higher. A Premier healthcare alliance report released in August estimated that the typical gray market vendor marks up prices by an averaged 650 percent. At the extreme, a drug used to treat high blood pressure that was normally priced at $25.90 was being sold at $1,200 due to a shortage.
These additional steps for early notification will help achieve some of the goals of bipartisan legislation sponsored by Senator Amy Klobuchar (S. 296) and Congresswoman Diana DeGette (D-CO) (H.R. 2245). Backed by the President, this legislation would require all prescription drug shortages to be disclosed and give the Food and Drug Administration new authority to enforce these requirements. In the meantime, to complement the broadened notification and consistent with the goals of this legislation, the FDA will establish a voluntary notification process that will encourage manufacturers to disclose more potential shortages.
Increased Staffing Resources for the FDA Drug Shortages Program
Over the coming weeks, the FDA will tap six to eight members of a surge team with critical skills from across the Department to work in the Drug Shortage Program to enhance the Agency’s ability to prevent and mitigate drug shortages as a result of increased early notification by manufacturers. When FDA becomes aware of a potential drug shortage, this Program works collaboratively with the affected firms to return the product to its usual market availability as quickly and as safely as possible while helping prevent any harm to patients. It also encourages other firms that make the drug to ramp up production if they are willing to do so, expedites the review of submissions from manufacturers which may include requests to extend the expiration date of products, increase capacity, use a new raw material source, license new manufacturers, and permit changes in product specifications. And, for manufacturing and quality problems, FDA works with the firm to address the issues.
New Analyses from the Department of Health and Human Services
The HHS Assistant Secretary for Planning and Evaluation conducted an assessment of the underlying economic factors that lead to prescription drug shortages, particularly market factors that have contributed to shortages of sterile injectable oncology drugs. The report finds that over the last several years, growth in demand has occurred while the capacity of manufacturing facilities has remained stable, unable to keep up with demand. Although sterile injectable drugs are a small percentage of the overall prescription drug market, they make up a disproportionate share of drugs in shortage and include critical drugs, such as oncology drugs. Their report concludes that over time, entry of additional manufacturing facilities, and expansions in capacity should reduce the frequency of shortages due to supply disruptions. The Administration plans on further outreach the industry, oncologists, and people with cancer to identify additional ideas on actions.
In addition, to better understand drug shortages, the FDA conducted a review of medical product shortage activities in its four medical product Centers, with an emphasis on reviewing what the agency has already done and is currently doing to address drug shortages. FDA also spoke with external stakeholders to understand their perspectives on the current drug shortage problem. Based on these conversations, a review of published and unpublished information on drug shortages, and analyses of databases either available or created for the report, the reports find that the shortage problem is complex and stems from economic, legal, regulatory, policy, and clinical decisions that are deeply interconnected. FDA continues to work with manufacturers to help prevent and mitigate these shortages, but many potential solutions to drug shortages will require collaborative efforts among all relevant stakeholders.
Key Facts about Drug Shortages
- The number of reported drug shortages annually has tripled from 61 in 2005 to 178 in 2010.
- Of the 127 studied shortages in 2010-11, 80 percent involved drugs delivered to patients by sterile injection, including oncology drugs, antibiotics, and electrolyte/nutrition drugs.
- The leading reasons for the reported shortages were problems at the manufacturing facility (43%), delays in manufacturing or shipping (15%), and active pharmaceutical ingredient shortages (10%).
- Manufacturing quality problems that have resulted in shortages can be serious, including findings of glass shards, metal filings, and fungal or other contamination in products meant for injection into patients.
Sterile injectable drugs have unique manufacturing and market features which make shortages of these products more likely to occur and harder to prevent or mitigate,including:
- Manufacturing them is complex and can more easily lead to problems that affect safety,
- Dedicated manufacturing lines are often required,
- The top three generic injectable manufacturers hold 71% of the market by volume,
- Most sterile injectables have one manufacturer that produces at least 90% of the drug, and
- “Just in time” manufacturing and inventorying practices leave little margin for error.
For Immediate Release
Washington Hilton and Towers
8:28 P.M. EDT
THE PRESIDENT: Hello, hello, hello! (Applause.) Thank you so much. (Applause.) Viva Italia! (Applause.) Thank you very much, everybody. Thank you. Thank you so much. (Applause.) Thank you, Nancy, for that generous introduction. I am biased, but I think Nancy was one of the best Speakers of the House this country ever had. (Applause.) She was no doubt the best Italian American Speaker of the House we ever had. (Applause.) And I believe that she will be the best Speaker of the House again in 2013. (Applause.)
Now, I was just out passing out Halloween candy — (laughter) — for the kids who were coming to the White House, but now that Malia and Sasha are with their friends, they do not notice that I’m gone. (Laughter.) They’re now getting to that age where they don’t care. (Laughter.) They’re pleased that I didn’t embarrass them too much during the brief time I was with them.
So I am honored to be here to celebrate National Italian American Heritage Month and to commemorate the 150th anniversary of Italian unification. (Applause.) And I want to congratulate the President, the Chairman, all of you who are doing so much work to keep that heritage alive for the next generation. And I’m grateful for your generous welcome. (Applause.)
Now, I want to make a confession right off the bat. I do not, in fact, have any Italian ancestry. (Laughter.) Not all of us are that lucky. (Laughter.) I can’t sing like Frankie Avalon. (Laughter.) Where’s Frankie? I can’t — he looks the same! Unbelievable. (Laughter and applause.) I can’t cook as well as any of your grandmothers. (Laughter.) Michelle won’t let me have seconds or thirds anymore. (Laughter.) So all I’ve got to offer is a last name that ends in a vowel. (Laughter and applause.) That’s all I’ve got. (Applause.)
Nevertheless, it is good to see so many amici. (Laughter.) I see many proud sons and daughters of the old country. I see a couple dozen proud Italian American members of Congress here tonight. Let me offer a special welcome to the guests who join us from Italy this evening, including Italy’s ambassador to the United States, Ambassador Terzi. Thank you so much for your outstanding work. (Applause.) His counterpart — here, as well, and he is doing an outstanding job representing us, our ambassador to Italy, David Thorne. (Applause.) Italy is one of our strongest allies, a fellow founding member of NATO. We look forward to our work together with them, and we’re going to be joining them next week at the G20 to make a series of decisions that are going to be very important for the world economy.
I’ve also made sure to keep close the advice of Italian Americans by asking some of them to serve in my Cabinet. And as Nancy mentioned, we could not be prouder of Janet Napolitano, who is keeping us safe every single day. (Applause.) And my outstanding Secretary of Defense, Leon Panetta. (Applause.) And, as was mentioned, even though she’s not here these evening, Jill Biden is proud to come from a long line of Giacoppas. And so she sends her regards. (Applause.)
Tonight, I think it’s also important for us to honor the proud service of the countless Italian Americans who have fought for this country since our founding, and who wear the uniform today — (applause) — from the Chief of Staff of the Army, General Ray Odierno, — (applause) — to a hero whom I was proud to bestow our nation’s highest military decoration, and was the first one in a very long time to personally receive the Medal of Honor, staff sergeant Salvatore Giunta. (Applause.)
So in a sense, every American joins us in celebrating this anniversary of Italian unification. What would America be without the contributions of Italy and Italian Americans? (Applause.) What would we be without the daring voyages of Columbus, and Verrazano, and Vespucci? What would our science and technology be without not just DaVinci and Galileo, but Fermi? What would movies and music be without the magic of Capra, or Sinatra, or Sophia Loren, my favorite. (Laughter.) I’m just saying. (Laughter.)
What would sports be without the guts and the grit of DiMaggio and Lombardi –- and LaRussa? (Applause.)
AUDIENCE MEMBER: Piazza!
THE PRESIDENT: Piazza! (Laughter and applause.) The White Sox could still use you. (Laughter.) What would this city be without the influence of Roman thought and architecture, the Piccirilli Brothers who — their work on the Lincoln Memorial; Brumidi’s magnificent touch on the Capitol?
Although, I must say, it might be nice to know what our politics would — like without the contribution of Machiavelli. (Laughter.) That’s been internalized a little too much here in Washington. (Laughter.)
America would not be what it is today without the unique contributions and the uncommon pride of Italian Americans. (Applause.) And like so many other groups — as Nancy said, like so many other groups, the Italians came to America in search of opportunity. They came with little. Very few were wealthy. But they came with an unwavering faith in God, an unfailing commitment to family, and an unlikely hope in the possibilities of America –- the belief that in this country, you could be prosperous, you could be free, you could think and talk and worship as you pleased. It was a place where you could make it if you try.
And it wasn’t always easy. Italians weren’t always welcome. And when we think about today’s immigrants, we have to remind ourselves that those of us who now feel comfortable in our American identity, that that wasn’t always the case in the past. (Applause.) The opportunities our forbears hoped for wasn’t always within reach right away. But they did not wait for anybody to hand it to them. They built new lives for themselves, and at the same time they ended up building an entire nation. They enriched our heritage and our culture with their own. They helped forge the very promise of this country — that success is possible if you’re willing to work for it. And those efforts built a better America for all of us.
Everybody in this room just about, everybody, has an ancestor or lots of ancestors who fit that story of transplanted roots that somehow grew in American soil; of families that struggled and sacrificed so that our families might know something better. Of parents who said, maybe I can’t speak English, but I'll make sure my child can speak English; they might teach English someday. (Applause.) I might not have an education, but I’m going to make sure my child has an education. (Applause.) I might perform backbreaking labor today, but someday my child can be a Senator, or a Supreme Court Justice, or Speaker of the House, or a Secretary in the Cabinet, or President of the United States. (Applause.)
So that’s what binds us together. That is what has always made our country unique. We’ve always been and we will always be a nation of immigrants from all over the world. And out of many, somehow we’re able to forge ourselves into one people; and this is the place where the highest hopes can be reached, and the deepest and most sincere dreams can be made real.
And that’s the legacy our forebears left for us, and that’s what we now have to leave to our children. These are tough times right now, and millions of Americans are hurting. Millions are without work, and those who have work are still all too often struggling to get by. And for many, the dream that brought so many Italian Americans to these shores feels like it’s slipping away.
So we’ve got work to do. But while these times are hard, we have to remind ourselves they’re not as hard as those that earlier generations faced. And the legacy of their courage and their commitment and their determination and their generosity and their willingness to think about the next generation — we have to be just as passionate and just as selfless as they were to keep that dream alive, and make sure our children inherit futures that are big and bright, and that this country is as generous as it’s always been.
And that’s what we have to commit to ourselves tonight. So on behalf of all Americans, I want to thank you for everything that the Italian American community has done; everything that you’ve done to contribute to the chronicles and the character of the greatest nation on Earth.
Thank you, so much. God bless you. God bless the United States of America. Thank you. (Applause.)
8:40 P.M. EDT
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Last night, President Barack Obama and First Lady Michelle Obama welcome area students and the children of military families to the White House for trick-or-treating.
Check out the video of the President and First Lady handing out cookies, White House M&M's and dried fruit mix to trick-or-treaters at the North Portico of the White House.
The White House and the surrounding grounds are decorated in celebration of Halloween. As the trick-or-treaters made their way across the North Lawn to the North Portico they were entertained by the Marine Band playing Halloween music and spooked by in-costume actors from Washington-area theatres, brought together by theatreWashington.
Check out the White House Halloween recipes below.
The White House Sweet Dough Butter Cookie Recipe
1 lb Sugar 1 tsp Vanilla
2 lbs Butter 1 tsp Salt
3 Eggs 3 lbs All Purpose Flour
Mix the butter and sugar till soft and well beaten. Then add eggs, vanilla, salt and half the flour. Beat on slow speed till mixed, then add the rest of the flour and mix until incorporated.
Push flat onto a cookie sheet and refrigerate overnight. Roll out to one quarter inch thick and cut out cookie shapes with cookie cutter.
Bake at 350F for 14 minutes and then allow to cool.
Make Your Own Dried Fruit Mix
Dried Apples Dried Pineapple
Dried Apricots Dried Papayas
Dried Pears Dried Cherries
Dried Blueberries Banana Chips
Combine ingredients and serve.