Reducing Prescription Drug Shortages, 68295-68296 [2011-28728]

Download as PDF Federal Register / Vol. 76, No. 213 / Thursday, November 3, 2011 / Presidential Documents 68295 Presidential Documents Executive Order 13588 of October 31, 2011 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. srobinson on DSK4SPTVN1PROD with MISCELLANEOUS 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 VerDate Mar<15>2010 17:06 Nov 02, 2011 Jkt 226001 PO 00000 Frm 00001 Fmt 4790 Sfmt 4790 E:\FR\FM\03NOE0.SGM 03NOE0 68296 Federal Register / Vol. 76, No. 213 / Thursday, November 3, 2011 / Presidential Documents 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. [FR Doc. 2011–28728 Filed 11–2–11; 11:15 am] Billing code 3295–F2–P VerDate Mar<15>2010 17:06 Nov 02, 2011 Jkt 226001 PO 00000 Frm 00002 Fmt 4790 Sfmt 4790 E:\FR\FM\03NOE0.SGM 03NOE0 OB#1.EPS</GPH> srobinson on DSK4SPTVN1PROD with MISCELLANEOUS THE WHITE HOUSE, October 31, 2011.

Agencies

[Federal Register Volume 76, Number 213 (Thursday, November 3, 2011)]
[Presidential Documents]
[Pages 68295-68296]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28728]




                        Presidential Documents 



Federal Register / Vol. 76 , No. 213 / Thursday, November 3, 2011 / 
Presidential Documents

[[Page 68295]]


                Executive Order 13588 of October 31, 2011

                
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

[[Page 68296]]

                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.
                
                
                    (Presidential Sig.)

                THE WHITE HOUSE,

                    October 31, 2011.

[FR Doc. 2011-28728
Filed 11-2-11; 11:15 am]
Billing code 3295-F2-P