Alison C. Abreu, MD

• Assistant Professor of Family Medicine and Psychiatry
• Roy J. and Lucille A. Carver College of Medicine
• University of Iowa
• Iowa City, Iowa

However metabolic disease associates in erie pa order 10mg dapagliflozin, collection of fines for labor violations diabetes diet bananas order dapagliflozin 5mg online, including child labor diabetes type 1 low carb diet generic dapagliflozin 10 mg, continues to be a challenge managing diabetes guy purchase 10 mg dapagliflozin overnight delivery. The United States and Peru held technical level consultations and a senior level Environmental Affairs Council meeting in an effort to resolve the matter. In July 2019, the United States took action to block future timber imports from a Peruvian exporter, based on illegally harvested timber found in its supply chain. This action was taken on behalf of the Interagency Committee on Trade in Timber Products from Peru (Timber Committee) following a 2018 verification exercise that revealed illegality in an earlier timber shipment from Peru to the United States. The United States continues to work closely with Singapore to deepen the bilateral trade relationship and coordinate on issues of regional and international importance. The United States and Ecuador have signed a Trade and Investment Council Agreement. In 2019, the United States and Argentina held the fifth meeting of the Forum, in Buenos Aires. With Brazil undertaking important economic initiatives to cut the cost of doing business, there are important opportunities to promote bilateral trade. The Council subsequently established six working groups: (1) intellectual property; (2) agriculture; (3) market access, customs, and trade facilitation; (4) labor; (5) environment; and, (6) investment, services, and digital trade. The working groups held videoconferences throughout 2019 and in December of 2019, the agriculture, labor, environment, and investment working groups met in Quito. However, in 2019, Paraguay was returned to the Special 301 Watch List for failing to meet key commitments. In December 2019, during the visit to the White House, Paraguayan President Benitez reaffirmed his willingness to continue strengthening intellectual property protections in Paraguay. The next meeting of the Trade and Investment Council is expected to be held in Montevideo in 2020. Transatlantic trade flows (goods and services trade plus earnings and payments on investment) averaged an estimated $6. On July 25, 2018, President Trump and European Commission President Juncker announced the formation of an Executive Working Group to work on a new and wide-ranging approach to eliminate tariff and nontariff barriers and increase trade. President Trump and President Juncker also instructed the Executive Working Group to focus on non-tariff barriers to transatlantic trade, with particular attention to technical barriers to trade. Each side developed a text proposal for an agreement on conformity assessment that would enable U. The two sides also discussed the use of standards in their respective regulatory systems, with a view to reducing barriers to exports and costs to manufacturers and to increasing trade. The region has seen uneven progress on economic and trade reforms, and many of the underlying economic drivers of political and social instability have yet to be addressed. In 2019, the United States continued to monitor, implement, and enforce existing U. Key issues of focus with Turkey remain the openness of the digital economy, intellectual property protection and enforcement, and the reduction of various market access barriers for both goods and services. Government officials held a number of meetings with their Ukrainian counterparts, culminating in the ninth meeting of the United States-Ukraine Trade and Investment Council. The delegations discussed a range of issues, including steps to remove regulatory barriers to U. Government economic delegation ever to visit Moldova attended the fourth meeting of the United States-Moldova Joint Commercial Commission, at which the delegations identified concrete steps to enhance bilateral trade and foster increased investment. The United States also maintained expert-level discussions with government officials of Georgia and Armenia on removing market access barriers in those respective countries. Nevertheless, as Russia continued to pursue industrial policies based on import substitution and local content requirements, the United States continued to identify and oppose those policies. The United States worked closely with Japan in various fora during 2019 to address trade issues of common interest, including those in third-country markets. In 2019, the United States raised and addressed a number of outstanding issues with Korea, including certain issues related to automobile greenhouse gas emission standards, fishing activities, agriculture, pharmaceuticals, chemicals, and information technology services. This included the establishment of the Building Blocks for Facilitating Digital Trade Pathfinder, championed by the United States. These projects are designed to improve efficiencies and reduce costs and delays that hinder U. Greater use of risk-based, scientific principles for food export certificates and adoption of the model wine certificate, where appropriate, could reduce administrative burdens on producers and traders. While Hong Kong generally provides robust protection and enforcement of intellectual property, the copyright system has not been updated since 2010, leaving the market vulnerable to digital copyright piracy. Final implementing regulations establishing such a mechanism entered into force in August 2019. The United States will continue to work to address and resolve the broad range of trade and investment issues important to U. The agreement applies to matters relating to international trade and investment and includes joint commitments to provide opportunities for public comment on proposed laws and regulations and to publish final laws and regulations. This publication commitment includes the obligation to publish final laws and regulations in English, which should make it easier for U. The transparency agreement also commits the two parties to ensure that administrative agencies apply fair, impartial, and reasonable procedures and that persons affected by the decisions of administrative agencies have a right to appeal those decisions. Additional commitments address the application of disciplines on bribery and corruption. The two sides discussed a range of bilateral trade and investment issues, including transparency, the investment climate, intellectual property protection, trade in cashmere, the U. In support of these objectives, the United States met throughout 2019 with countries in Southeast Asia and the Pacific to pursue trade outcomes that will increase U. Total two-way goods trade with Sub-Saharan Africa was $37 billion in 2019, exports were $15. Government officials, representatives from Congress, and private sector and civil society representatives. United States Announces Intent to Initiate Trade Negotiations with Kenya On February 6, 2020, President Trump announced the United States intends to initiate trade agreement negotiations with Kenya following a meeting at the White House with Kenyan President Uhuru Kenyatta. The Working Group, established by President Trump and President Kenyatta in August 2018, is exploring ways to deepen the trade and investment ties between the two countries and lay the groundwork for a stronger future trade relationship. From October 31 through November 4, 2019, Kenya hosted the second meeting of the Working Group in Nairobi, Kenya. Government tools that facilitate private sector activity and foster transparent and conducive business-enabling environments in Africa. More than 2,000 senior business and government leaders participated in the Summit. Government officials took part in the opening session, which also included five different African heads of state. The Summit also featured a final investment decision for the largest single investment in African history, a $20 billion natural gas development project in northern Mozambique led by a U. Agency for International Development maintains three Trade and Investment Hubs in sub-Saharan Africa that provide extensive support to the U. In addition, issues related to digital trade assumed increasing prominence in 2019, and are expected to remain an important focus of U. A Trade Policy Forum exists to facilitate trade and investment dialogue between the United States and India. Recent Developments in United States-India Trade Relations During 2019, the United States engaged extensively with India to try to resolve longstanding market access impediments affecting U. Recent Indian emphasis on import substitution through a "Make in India" campaign has epitomized the challenges facing the bilateral trade relationship. Despite sustained efforts in this area, there has not been significant progress in the areas of freedom of association and worker rights laws. Along with the five Central Asian countries (Kazakhstan, Kyrgyz Republic, Tajikistan, Turkmenistan, and Uzbekistan), two observer countries ­Afghanistan and Pakistan ­ also participated. Government monitoring of foreign government compliance with trade agreements to which the United States is a party and pursues enforcement actions using dispute settlement procedures and applying the full range of U. Departments of Agriculture, Commerce, Justice, Labor, and State, help ensure that these agreements yield the maximum benefits in terms of ensuring market access for Americans, advancing the rule of law internationally, and creating a fair, open, and predictable trading environment. Favorable Resolutions or Settlements By filing disputes, the United States aims to secure benefits for U. Therefore, whenever possible, the United States has sought to reach favorable resolutions or settlements that eliminate the foreign breach without having to resort to panel proceedings. Section 301 Section 301 of the Trade Act of 1974 (Trade Act) is designed to address foreign unfair practices affecting U.

Information and Referral: Knowledge provided to a consumer diabete cause generic 5 mg dapagliflozin otc, family member diabetes symptoms male buy 5mg dapagliflozin with amex, provider diabetes type 2 case study buy dapagliflozin 10mg on-line, or other advocate to aid the consumer in finding the right technology diabetic urine whiskey order dapagliflozin 10 mg free shipping. Direction or otherwise linking someone to the correct professional program, service, or agency that will supply or play a major part in helping the consumer get assistive technology. Information Technology: Information technology includes any product used to acquire, store, manipulate, or transmit information, such as computers, multimedia, telecommunications, copy machines, and the Internet. Informational interview: An activity where students meet with people working in careers to ask questions about their jobs and companies, allowing students to gain personal perspectives on career interests. Insured Status: If you earned enough Social Security credits to meet the eligibility requirement for retirement or disability benefits or enable your dependents to establish eligibility for benefits due to your retirement, disability, or death, you have insured status. Intake: the phase of a workforce development program during which applicants are oriented to the program and discuss their eligibility to participate. Internet: Computer network connecting governmental, educational, commercial, other organizations, and individual computer systems. Internship: A time-limited, intensive learning experience outside of the typical classroom. Interpreter: Professional person who assists a person who is deaf in communicating with hearing people. Intervention: the act of intervening, interfering or interceding with the intent of modifying the outcome. In medicine, an intervention is usually undertaken to help treat or cure a condition. Job Club: A type of self-directed job search program in which clients meet regularly as a peer support group to learn job-search techniques and to telephone potential employers and arrange interviews. Job Search Assistance: A category of employer outreach that includes (1) training to help clients find their own jobs (self-directed job search), (2) job leads for clients, and (3) onthe-job training. Job shadowing: A short work-based learning experience where students visit businesses to observe one or more specific jobs to provide them with a realistic view of occupations in a variety of settings. Other joysticks plug into game ports and depend on software that is designed to accept joystick control. Keyboards Additions: A variety of accessories have been designed to make keyboards more accessible. Using a keyguard, someone with an unsteady finger or with a pointing device can avoid striking unwanted keys. Moisture guards are thin sheets of plastic that protect keyboards from spills and drooling. The clearly defined spaces between keys provided by the keyguards helps him more easily select the keys he wants. Keyboard emulation: Uses hardware and/or software in place of a standard keyboard. Labor Dispute: Any controversy concerning terms or conditions of employment, or concerning the association or representation of persons in negotiating, fixing, maintaining, changing, or seeking to arrange terms or conditions of employment, regardless of whether or not the disputants stand in the proximate relation of employer and employee. Labor Force: the sum of individuals who are 16 years old or older and either employed or counted as unemployed, including persons in the military. Large-print: Most ordinary print is six to ten points in height (about 1/16 to 1/8 of an inch). Largeprint type is fourteen to eighteen points (about 1/8 to 1/4 of an inch) and sometimes larger. The term does not include children who have learning problems which are mainly the result of visual, hearing, or motor handicaps, mental retardation, emotional disturbance, of environmental, cultural, or economic disadvantage. The box can also be used to assist with better viewing of certain types of photos, to highlight handwriting skills and increase visual memory. Life Skills Training: A form of pre-employment training that prepares job seekers who have few job skills or little workplace experience. It provides job seekers with information on what it takes to be hired and to keep a job. Typical components in this training include the importance of a strong work ethic, punctuality and reliability, a positive attitude, dressing for success, effective interview techniques, budgeting, conflict resolution and how to get along with supervisors and co-workers Lifetime Earnings: See Earnings Record. The key elements in the labor market are the workers (labor resources) and jobs (employment opportunities). Long-Term Unemployment: Persons who have been unemployed for 15 or more consecutive weeks. Low Vision Simulation Kit: (See Vision and Hearing Loss Simulation Kit) Lump Sum Death Payment: A one-time payment of $255 paid in addition to any monthly survivors insurance benefits that are due. Macro: A mini-program that, when run within an application, executes a series of predetermined keystrokes and commands to accomplish a specific task. Macros can automate tedious and often-repeated tasks or create special menus to speed data entry. Major Life Activity: the basic activities that the average person in the general population can perform with little or no difficulty. Examples include: caring for oneself, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, and working, etc. Maximum Earnings: the maximum earnings we can count for any calendar year when computing your Social Security benefit. The median is the point where half of the numbers lie above and half lie below this value Mediation: Negotiation that involves a third party who is neutral on the conflict; "facilitated negotiation. Medicaid programs vary from state to state, but most health care costs are covered if you qualify for both Medicare and Medicaid. The brain engages in a remarkable reshuffling process in an attempt to extract what is general and what is particular about each passing moment. These limitations will cause a child to learn and develop more slowly than a typical child. Children with mental retardation may take longer to learn to speak, walk, and take care of their personal needs such as dressing or eating. In fact, 1 out of every 10 children who need special education has some form of mental retardation. Mentors: Mentoring is the deliberate pairing of a more skilled or experienced person with a lesser skilled or experienced one, with the agreed-upon goal of having the lesser skilled person grow and develop with specific life/work skills and competencies. Mentors may counsel new employees on any issue from managing time and stress to balancing work and home commitments or maintaining professional work habits and handling office relationships and conflicts appropriately. Length of commitment between mentor and mentee typically ranges from a few months to a year or more. The program has reports on mass layoff actions that result in workers being separated from their jobs. Mobility and Transportation Aids: Products that help mobility impaired persons move within their environment and give them independence in personal transportation. Includes standing/walking aids, transfer aids, stair lifts, walkers, scooters, wheelchairs and Photo of all-terrain wheelchair courtesy of Infintec three-wheeled chairs, adapted bikes and Trikes, car seats/bed, stretchers, patient chairs, ramps, recliners, strollers, travel chairs, wheelchair trays, driving controls, seat belts, vehicle conversions, patient and wheelchair lifts, wheelchair loaders/carriers, wheelchair restraint systems, etc. In certain situations, you can choose the month in which your benefits will start. There are many different factors that can affect when you want to begin receiving your payments. For example, a motor neuron is a nerve cell that conveys an impulse to a muscle causing it to contract. The term "motor" today is also applied to a nerve that signals a gland to secrete. Motor Planning: Ability to automatically start, perform, and complete a series of movements to achieve a desired outcome. These natural supports are particularly effective as they enhance the social integration of the employee with a disability with his or her co-workers and supervisor. In addition, natural supports are more permanent, part of the workplace and more readily available than paid job coaches, thereby facilitating long-term job retention. Nerve: A bundle of fibers that uses chemical and electrical signals to transmit sensory and motor information from one body part to another. Non-institutional: Persons not residing in penal or mental institutions, sanitariums, and homes for the aged, infirm, and needy. Not in the Labor Force: All persons in the civilian non-institutional population who are neither employed nor counted as unemployed are "not in the labor force. Department of Labor, Employment & Training Administration 260 Occupation: A set of activities or tasks that employees perform.

In order to make that case medications for diabetes order 10 mg dapagliflozin, she shows how changes in the structure of interaction diabetes mellitus polydipsia buy discount dapagliflozin 5mg on line, driven by the aims of the "pro-tactile" social movement diabetes in dogs urination order dapagliflozin 10 mg fast delivery, contributed to a redistribution of complexity across grammatical sub-systems blood sugar quinoa best 5 mg dapagliflozin. In doing so, she apprehends language emergence not as a "liberation" from context, but as a process of contextual integration. It focuses on social-haptic communication, a form of touch communication that augments verbal or signed language. A hapteme is received through a body channel, in which the whole body is transmitting touch information. This paper reports the results of a study of tactile Auslan conversations, paying particular attention to how experienced tactile signers resolve misunderstandings, often caused by the absence of non-manual signals in tactile sign. The authors provide examples of conversations analyzed to highlight important features of their findings. The third annual conference aimed at identifying what was happening in interpreting for deafblind people in Europe and to share ideas, information and materials on this subject. Additional technical papers that review recent research, developments and models of training are included in the proceedings as well. This paper addresses the need for a theoretical model of interpreting for people who are both deaf and blind, lays out a version of a process model based on the works of Colonomos, Cokely and Seleskovitch, and then expands this model, viewing it through the lens of Deaf-Blind interpreting. Many members of the Seattle Deaf-Blind community were born deaf and, due to a genetic condition, lose their vision slowly over the course of many years. This book chapter explores how visual perception and manual production interact at the level of phonology in sign language. Speculations regarding the development of visualmotor integration for sign language, implications of the direct perception of the sign articulators, and some unique problems that sign language raises for the perceptual loop hypothesis of language monitoring are presented. Includes a discussion of visual Page 32 Research and Theory in Deaf-Blind Interpreting monitoring of sign output for signers with Usher syndrome. The purpose of this study was to examine the ability of experienced deaf-blind subjects to receive fingerspelled materials, including sentences and connected text, through the tactual sense. The study concluded that tactual spelling is sent and received with excellent accuracy at 2-6 letters per second. Visual reception, on the other hand, with the use of variable speed videotape playback, could be shown to be much faster than the sender can form the letters. In the study reported here, 10 experienced deaf-blind users of either American Sign Language or Pidgin Sign English participated in experiments to determine their ability to receive signed materials including isolated signs and sentences. Page 33 Research and Theory in Deaf-Blind Interpreting this dissertation is primarily about turn-taking and questions as they are carried out in tactile conversation. Finally the book examines support questions and how conversational participants support one another by requesting feedback and clarification. Signers with tunnel vision produced a greater proportion of signs near the face than blind and normally sighted signers, who did not differ from each other. Both groups of visually impaired signers produced signs within a smaller signing space for conversations than for monologues. Signers with tunnel vision may align their signing space with that of their interlocutor. In contrast, blind signers may enhance proprioceptive feedback by producing signs within an enlarged signing space for monologues, which do not require switching between tactile and visual signing. Page 35 Preparing for an Interpreting Assignment the resources in this section cover information for both presenters and interpreters working with deaf-blind people. Topics include a discussion of the types of expertise that interpreters need (deaf-blind vs. These revised guidelines provide interpreters and interpreting agencies with an awareness of the unique needs of DeafBlind people and their individual interpreting needs. It is important to remember that support needs vary greatly among DeafBlind people. This article discusses the need for interpreters to be more aware of the possibility that the deaf client may also have low vision needs. The article includes additional guidelines for interpreting for deaf-blind people. Article discusses the difficulties an interpreter faces when trying to interpret for speakers at conferences. This brochure is an aid for those who are interpreting for persons who are deaf-blind. This brief article outlines six environmental adaptations that can be made to support a person who is deafblind in their independence and self-sufficiency. The adaptations are primarily intended for the home environment, but the concepts can be generalized to an awareness of environmental factors that can pose barriers. Tips on receiving tactile communication as well as tips on providing tactile communication are listed. Article includes specific techniques and guidelines for human guides working with travelers who are deaf-blind. This book was written to help service providers in working with persons who are deafblind. Sections on service needs, communication, orientation and mobility, sensory deprivation and a survey of dog guide schools. This video describes the Seattle Deaf-Blind Community and the Role of the Support Service Provider. The curriculum is available for a free download from the Seattle Deaf-Blind Service Center at: seattledbsc. The section on a good consumer includes attitude, skills and knowledge, and speaking up. Rhonda talked with Jamie and Aimee about deaf-blind culture, interactions with deaf-blind people, and how interpreters can integrate knowledge of deaf-blindness into their work. It describes the difficulties and adjustment associated with becoming blind while deaf. Four people are interviewed and tell (with the assistance of interpreters) what life is like for them. How do those who are living with a difference most effectively cross the cultural divide and Page 43 Culture and Community explain themselves to mainstream society? This is a central question raised by Yvonne Pitrois in her biography of Helen Keller, titled "Une nuit rayonnante: Helen Keller" [A Shining Night: Helen Keller]. This collection presents 95 poems by 35 Deaf American poets from the signing community over the past two centuries. It includes 4 poems by John Lee Clark, a deafblind poet and the editor of this collection. This 90-minute video offers two presentations of a 45-minute conversation with Pat Cave and Janice Adams, two Deaf-Blind individuals. Among topics discussed are a definition and description of the community, individual communicative differences and preferences, becoming involved in the community, and setting limits. This resource also makes use of video footage to illustrate guiding and communication preferences. This is an interview with two members of the deaf-blind community in which they share their perceptions of their lives and experiences working with interpreters. This one page article advocates for individuals who are deaf-blind to be included and not isolated. It takes note of individual accomplishments as well as the achievements of organizations for the deaf-blind. The article notes several characteristics unique to the deaf-blind culture: touch, group communication, dependence on interpreters, social mores imposed by deaf-blindness, games, class barriers, reduced general knowledge, economics, and language. He discusses medical advances and Page 45 Culture and Community the desire by some in the medical profession to eradicate deafness. The author celebrates his deafness as well as blindness and believes it is an important fabric of human life. This second edition of Guidelines includes expanded chapters on topics such as tactile sign language, interpreting, conversation and physical environment. This 7-minute video describes the Seattle Deaf-Blind Community and the Role of the Support Service Provider.

Similarly diabetes type 1 icd 9 dapagliflozin 10mg sale, benefits may be excessive for those firms that anticipate a large volume of off label sales for a drug that comes to market as an orphan diabetes testing supplies dapagliflozin 5mg discount. That is particularly true given that the lower threshold for clinical trials for orphan products likely results in lower development costs for these products diabetes type 2 celebrities order 10 mg dapagliflozin with amex. On the other side of the ledger diabetes test devices buy generic dapagliflozin 10 mg on-line, firms receive fixed benefits whether or not a drug candidate is likely to face meaning ful generic competition. In this situa tion, market exclusivity cannot correct a perceived investment shortfall in orphan drugs. Both the concerns about rewarding inframarginal products and pro viding an inappropriate level of assistance to marginal products could be addressed if the fixed, numerical prevalence threshold were aban doned. Policymakers could then target incentives to novel drugs or to novel the Orphan Drug Act at 35 131 uses for existing drugs. As the Humira case study suggests, new in dications can sometimes create value in the form of increased use. In other cases, however, new indications appear to simply codify an exist ing off label use, which provides fewer welfare benefits. Depending on whether a new indication demonstrates a genuinely novel use for an existing drug, orphan drug approval will have different effects on welfare and will likely present a different value proposition for firms. An ideal policy would acknowledge those differences and adjust incen tives accordingly. At a minimum, identifying drug candidates that truly need additional R&D support would require providing regulators with new legal authority. In addition, regulators would require meaningful new resources and expertise to adequately shoulder these new responsi bilities. For example, understanding the potential value of a new use might require regulators to systematically monitor off label use of exist ing products. These potential costs highlight the appeal of a bright line rule to qualify for orphan drug status. The appeal of extending uniform benefits to all drugs with an orphan drug approval follows similar logic: it yields certainty for manufacturers and regulators alike. In both cases, simplic ity reduces decision costs and mitigates certain risks of gamesmanship and regulatory capture. It is not clear, however, that the benefits associated with a rule bound approach outweigh its costs-especially as the costs of that rule bound approach increase over time. It certainly is unlikely that any implicit calculations supporting the policy choices made in 1984 remain valid in the pharmaceutical market that has emerged over subsequent decades. While imple mentation difficulties should be considered, they should not stand as an insurmountable obstacle to more efficient policy. Setting aside which drugs should receive incentives, policymakers should also consider the nature of those incentives. Both are intended to increase the expected profits of an investment in drug development by both lowering the costs and increasing the revenues associated with the commercialization process. The funding sources of these two incentives are distinct, however, and their economic impacts differ meaningfully. The tax credit is funded from general tax revenue and therefore has a relatively broad base of financial support. Thus, inefficiency arises from the general deadweight loss of raising government funds and the op portunity cost of how those funds could be otherwise spent. In contrast, the period of market exclusivity results in a protracted period of higher drug prices. In a world with no cost sharing, those prices would spur higher insurance premiums across the entire risk pool. Higher premi ums would in turn distort the purchase decision for insurance; the re sulting welfare losses would fall most acutely on the privately insured. Those cost burdens are compounded to the extent that insurers employ differential cost sharing for orphan and other specialty products. In that case, the benefits of orphan products would be financed, in part, through an effective tax on individuals with orphan conditions. That tax partly unwinds the insurance product for those individuals, result ing in an inefficiently low consumption of drugs and an inadequate level of risk protection. These differential funding sources imply that in some cases tax cred its may be a superior incentive mechanism relative to extended market exclusivity. The case for tax credits becomes stronger because they can be clawed back by regulators in the event that the product is more suc cessful than expected at the time of its orphan drug application. Ter minating an exclusivity period, however, may not immediately induce competition, even in rivalrous markets. Generic manufacturers may be uncertain about the date that the exclusivity period will lapse, increas ing the uncertainty associated with the development of a competitor product. Terminating tax credits, in contrast, would not have a similar ef fect on market dynamics. In addition, such a system has already been shown to be administrable: in Japan, for example, manufacturers must repay R&D subsidies for drugs with annual sales that exceed 100 million yen (Wellman Labadie and Zhou 2010). Tax credits are not panaceas: firms may be able to game such a tax credit by allocating fixed costs that were not truly related to the development of an orphan product. They do, however, have distinct advantages over fixed periods of market exclusivity. If eligibility for or phan drug status or the size of R&D incentives hinged on an ex ante as sessment of economic viability, firms would, at the margin, be tempted to game the system, either by overstating costs or understating poten tial revenues. Because regulators would have a difficult time preventing such gamesmanship, terminating incentives once a manufacturer has recouped its risk adjusted R&D investment might be a more construc tive approach. In an ideal world, affording greater flexibility to regulators could allay many of the economic con cerns associated with the current regime. In a non ideal world, how ever, it is an open question whether regulators have (or will be given) the capacity, legal authority, and resources to develop and fairly admin ister a better calibrated orphan drug policy. At a minimum, policy ap proaches that allow the government to direct incentives to the develop ment of orphan drugs that would otherwise not be economically viable hold substantial promise. A new chemical entity that is approved as an orphan product, however, also receives a seven year period of orphan drug exclusivity, which runs concurrently with (and thus extends two years beyond) the five years of exclu sivity for new chemical entities. A previously approved product can receive multiple orphan indications, with a separate seven years of regulatory exclusivity for each new indication. A manufacturer can also seek an orphan designation for conditions that target more than 200,000 patients, but only if it demonstrates that "no reasonable expectation that costs of research and development of the drug for the disease or condition can be recovered by sales of the drug in the U. The general equilibrium welfare implications of this are unclear, as the existence of market exclusivity increases the availability of products. This discussion may make it seem as if biomarkers increase the ability to price dis criminate only where a drug has both orphan and nonorphan uses. But even for drugs with solely orphan applications, a biomarker that better predicts benefit. The two categories overlap to some extent: for example, certain cystic fibrosis transmembrane conductance regulator mutations can be used as both diagnostic and predictive biomarkers to select patients for therapies or clinical trials. However, other costs associated with clinical research, such as patient recruitment, may go up in this setting. For completeness, it is important to note that this would also be consistent with a simple error by a firm that expected an increase in utilization from the new indication, but was wrong. It would also be consistent with limited or absent coverage by payers for a new orphan drug-even "on label. While we lack complete insight into the rebate structure, this is a smaller concern when examining the distribution of expenditures across indications within a product be cause rebates are not currently tied to particular indications. As noted above, this conclusion requires that the drug has broad coverage among patients. This source of inefficiency should not be confused with applying "orphan drug" prices to a broader population. To the extent that the manufacturer is a rational profit maximizing firm, it will set a price that would cause a payer to allow the broader population access to the product. This is particularly true given that a payer can relatively easily imple ment utilization management techniques to limit access to a product for off label indications. Orphan Drug Approvals and Designations Sky rocketed in 2017, While Orphan Drug Designation Requests Dipped Slightly. The addition o[bicarbonate in hypertonic solutions produces a greater elevation o[Pco~ and blood p H may actually [all. The acidosis associated with hypertonicity o[extraeelIular fluids results [rom the dilution o[extracellular buffers and the release o[protons [rom intracellular buffers, such as hemoglobin, in response to the increase in ionic strength.

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