(cid:44)(cid:81)(cid:73)(cid:82)(cid:85)(cid:80)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:38)(cid:82)(cid:81)(cid:86)(cid:88)(cid:80)(cid:72)(cid:85)(cid:86)(cid:3)(cid:11)(cid:39)(cid:85)(cid:88)(cid:74)(cid:86)(cid:12)(cid:3)(cid:33)(cid:3)(cid:50)(cid:85)(cid:83)(cid:75)(cid:68)(cid:81)(cid:3)(cid:51)(cid:85)(cid:82)(cid:71)(cid:88)(cid:70)(cid:87)(cid:86)(cid:29)(cid:3)(cid:43)(cid:82)(cid:83)(cid:72)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:51)(cid:72)(cid:82)(cid:83)(cid:79)(cid:72)(cid:3)(cid:58)(cid:76)(cid:87)(cid:75)(cid:3)(cid:53)(cid:68)(cid:85)(cid:72)(cid:3)(cid:39)(cid:76)(cid:86)(cid:72)(cid:68)(cid:17)(cid:17)(cid:17)
`
`(cid:51)(cid:68)(cid:74)(cid:72)(cid:3)(cid:20) (cid:82)(cid:73)(cid:3)(cid:23)
`
`Home Drugs Resources for You Information for Consumers (Drugs)
`(cid:39)(cid:85)(cid:88)(cid:74)(cid:86)
`(cid:50)(cid:85)(cid:83)(cid:75)(cid:68)(cid:81)(cid:3)(cid:51)(cid:85)(cid:82)(cid:71)(cid:88)(cid:70)(cid:87)(cid:86)(cid:29)(cid:3)(cid:43)(cid:82)(cid:83)(cid:72)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:51)(cid:72)(cid:82)(cid:83)(cid:79)(cid:72)(cid:3)(cid:58)(cid:76)(cid:87)(cid:75)(cid:3)(cid:53)(cid:68)(cid:85)(cid:72)(cid:3)(cid:39)(cid:76)(cid:86)(cid:72)(cid:68)(cid:86)(cid:72)(cid:86)
`
`Jumping Frenchmen of Maine sounds like an uproarious, modern-
`day stage show or even a new wave rock group. But it's neither.
`It's the name of an unusual disorder that causes an extreme startle
`reaction to unexpected noises or sights. Though little is known
`about Jumping Frenchmen of Maine, the disorder and more than
`6,000 other rare or "orphan" diseases are receiving increasing
`attention from the government, patient groups, and the
`pharmaceutical industry.
`An orphan disease is defined as a condition that affects fewer than
`200,000 people nationwide. This includes diseases as familiar as
`cystic fibrosis, Lou Gehrig's disease, and Tourette's syndrome, and
`as unfamiliar as Hamburger disease, Job syndrome, and
`FDA Rare Disease Patient
`acromegaly, or "gigantism." Some diseases have patient
`Advocacy Day, 20121
`populations of fewer than a hundred. Collectively, however, they
`affect as many as 25 million Americans, according to the National Institutes of Health (NIH), and
`that makes the diseases--and finding treatments for them--a serious public health concern.
`
`Most Inherit Orphan Diseases
`New rare diseases are discovered every year. Most are inherited and caused by alterations or
`defects in genes (mutations). Others can be acquired as a result of environmental and toxic
`conditions. Genes are pieces of DNA, part of the code that determines the traits and individual
`characteristics of all living things. Each human cell contains around 30,000 genes. Besides
`influencing features such as eye and hair color, genes also can play a role in the development of
`diseases and in their transmission from parent to child.
`As disparate as rare diseases are, patients share many common frustrations. For example, for one-
`third of people with a rare disease, getting an accurate diagnosis can take one to five years. And
`people often are so isolated that they may never know anyone else with the same disease. Patients
`often must travel long distances to visit the few doctors knowledgeable about their illnesses, and
`the costs involved with diagnosis, treatment, and other related expenses can be exorbitant.
`
`Managing Rare Diseases
`Many rare diseases or conditions can be difficult to diagnose and manage because in their early
`stages, symptoms may be absent or masked, misunderstood, or confused with other diseases.
`For example, adrenomyeloneuropathy (AMN), one of a group of genetically determined progressive
`disorders known as leukodystrophies that affect the brain, spinal cord, and peripheral nerves, is
`often misdiagnosed as multiple sclerosis (MS), according to the United Leukodystrophy Foundation.
`Since diagnosis of neurological conditions relies on subtle and circumstantial evidence, even the
`most experienced clinicians may have difficulty distinguishing between the two. For rare disease
`patients, there may be no cures, but treatments of the symptoms can help. Participating in a
`clinical trial may be a way to receive the most advanced care for some diseases. People who
`experience unexplained symptoms, recurrent infections, and pain that have gone undiagnosed for a
`long period of time might want to visit a referral center that is experienced in diagnosing patients
`with rare diseases. Some rare diseases do not have clearly defined treatment guidelines and
`require the specific skills of an expert physician. Be sure to go to a hospital that is familiar with
`treating people with multiple problems.
`
`CFAD Exhibit 1079
`CFAD v. NPS
`IPR2015-01093
`
`(cid:75)(cid:87)(cid:87)(cid:83)(cid:29)(cid:18)(cid:18)(cid:90)(cid:90)(cid:90)(cid:17)(cid:73)(cid:71)(cid:68)(cid:17)(cid:74)(cid:82)(cid:89)(cid:18)(cid:71)(cid:85)(cid:88)(cid:74)(cid:86)(cid:18)(cid:85)(cid:72)(cid:86)(cid:82)(cid:88)(cid:85)(cid:70)(cid:72)(cid:86)(cid:73)(cid:82)(cid:85)(cid:92)(cid:82)(cid:88)(cid:18)(cid:70)(cid:82)(cid:81)(cid:86)(cid:88)(cid:80)(cid:72)(cid:85)(cid:86)(cid:18)(cid:88)(cid:70)(cid:80)(cid:20)(cid:23)(cid:22)(cid:24)(cid:25)(cid:22)(cid:17)(cid:75)(cid:87)(cid:80)
`
`
`
`(cid:51)(cid:68)(cid:74)(cid:72)(cid:3)(cid:20) (cid:82)(cid:73)(cid:3)(cid:23)
`
`Home Drugs Resources for You Information for Consumers (Drugs)
`(cid:39)(cid:85)(cid:88)(cid:74)(cid:86)
`(cid:50)(cid:85)(cid:83)(cid:75)(cid:68)(cid:81)(cid:3)(cid:51)(cid:85)(cid:82)(cid:71)(cid:88)(cid:70)(cid:87)(cid:86)(cid:29)(cid:3)(cid:43)(cid:82)(cid:83)(cid:72)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:51)(cid:72)(cid:82)(cid:83)(cid:79)(cid:72)(cid:3)(cid:58)(cid:76)(cid:87)(cid:75)(cid:3)(cid:53)(cid:68)(cid:85)(cid:72)(cid:3)(cid:39)(cid:76)(cid:86)(cid:72)(cid:68)(cid:86)(cid:72)(cid:86)
`
`Jumping Frenchmen of Maine sounds like an uproarious, modern-
`day stage show or even a new wave rock group. But it's neither.
`It's the name of an unusual disorder that causes an extreme startle
`reaction to unexpected noises or sights. Though little is known
`about Jumping Frenchmen of Maine, the disorder and more than
`6,000 other rare or "orphan" diseases are receiving increasing
`attention from the government, patient groups, and the
`pharmaceutical industry.
`An orphan disease is defined as a condition that affects fewer than
`200,000 people nationwide. This includes diseases as familiar as
`cystic fibrosis, Lou Gehrig's disease, and Tourette's syndrome, and
`as unfamiliar as Hamburger disease, Job syndrome, and
`FDA Rare Disease Patient
`acromegaly, or "gigantism." Some diseases have patient
`Advocacy Day, 20121
`populations of fewer than a hundred. Collectively, however, they
`affect as many as 25 million Americans, according to the National Institutes of Health (NIH), and
`that makes the diseases--and finding treatments for them--a serious public health concern.
`
`Most Inherit Orphan Diseases
`New rare diseases are discovered every year. Most are inherited and caused by alterations or
`defects in genes (mutations). Others can be acquired as a result of environmental and toxic
`conditions. Genes are pieces of DNA, part of the code that determines the traits and individual
`characteristics of all living things. Each human cell contains around 30,000 genes. Besides
`influencing features such as eye and hair color, genes also can play a role in the development of
`diseases and in their transmission from parent to child.
`As disparate as rare diseases are, patients share many common frustrations. For example, for one-
`third of people with a rare disease, getting an accurate diagnosis can take one to five years. And
`people often are so isolated that they may never know anyone else with the same disease. Patients
`often must travel long distances to visit the few doctors knowledgeable about their illnesses, and
`the costs involved with diagnosis, treatment, and other related expenses can be exorbitant.
`
`Managing Rare Diseases
`Many rare diseases or conditions can be difficult to diagnose and manage because in their early
`stages, symptoms may be absent or masked, misunderstood, or confused with other diseases.
`For example, adrenomyeloneuropathy (AMN), one of a group of genetically determined progressive
`disorders known as leukodystrophies that affect the brain, spinal cord, and peripheral nerves, is
`often misdiagnosed as multiple sclerosis (MS), according to the United Leukodystrophy Foundation.
`Since diagnosis of neurological conditions relies on subtle and circumstantial evidence, even the
`most experienced clinicians may have difficulty distinguishing between the two. For rare disease
`patients, there may be no cures, but treatments of the symptoms can help. Participating in a
`clinical trial may be a way to receive the most advanced care for some diseases. People who
`experience unexplained symptoms, recurrent infections, and pain that have gone undiagnosed for a
`long period of time might want to visit a referral center that is experienced in diagnosing patients
`with rare diseases. Some rare diseases do not have clearly defined treatment guidelines and
`require the specific skills of an expert physician. Be sure to go to a hospital that is familiar with
`treating people with multiple problems.
`
`CFAD Exhibit 1079
`CFAD v. NPS
`IPR2015-01093
`
`(cid:75)(cid:87)(cid:87)(cid:83)(cid:29)(cid:18)(cid:18)(cid:90)(cid:90)(cid:90)(cid:17)(cid:73)(cid:71)(cid:68)(cid:17)(cid:74)(cid:82)(cid:89)(cid:18)(cid:71)(cid:85)(cid:88)(cid:74)(cid:86)(cid:18)(cid:85)(cid:72)(cid:86)(cid:82)(cid:88)(cid:85)(cid:70)(cid:72)(cid:86)(cid:73)(cid:82)(cid:85)(cid:92)(cid:82)(cid:88)(cid:18)(cid:70)(cid:82)(cid:81)(cid:86)(cid:88)(cid:80)(cid:72)(cid:85)(cid:86)(cid:18)(cid:88)(cid:70)(cid:80)(cid:20)(cid:23)(cid:22)(cid:24)(cid:25)(cid:22)(cid:17)(cid:75)(cid:87)(cid:80)
`
`
`
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`
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`
`Adopting the 'Orphans'
`Before the passage of rare disease laws in the United States, patients diagnosed with a rare
`disease were denied access to effective medicines because prescription drug manufacturers rarely
`could make a profit from marketing drugs to such small groups. Consequently, the prescription
`drug industry did not adequately fund research for orphan product development. Other potential
`sources, such as research hospitals and universities, also lacked the capital and business expertise
`to develop treatments for small patient groups. Despite the urgent health need for these
`medicines, they came to be known as orphans because companies were not interested in adopting
`them.
`This changed in 1983 when Congress passed the Orphan Drug Act (ODA). The ODA created
`financial incentives for drug and biologics manufacturers, including tax credits for costs of clinical
`research, government grant funding, assistance for clinical research, and a seven-year period of
`exclusive marketing given to the first sponsor of an orphan-designated product who obtains market
`approval from the Food and Drug Administration for the same indication. At the same time, federal
`programs at the FDA and the NIH began encouraging product development, as well as clinical
`research for products targeting rare diseases.
`Since 1983, the ODA has resulted in the development of more than 250 orphan drugs, which now
`are available to treat a potential patient population of more than 13 million Americans. In contrast,
`the decade before 1983 saw fewer than 10 such products developed without government
`assistance. As a result of the ODA, treatments are available to people with rare diseases who once
`had no hope for survival.
`"A lot of people are affected," says Marlene E. Haffner, M.D., M.P.H., director of the FDA's Office of
`Orphan Products Development (OOPD). "That makes it a major public health impact, and in time,
`we're going to see even more rare diseases requiring treatment."
`Despite the success of the ODA, however, rare disease advocacy groups argue that the plight of
`people with orphan diseases deserves even more attention.
`
`Patient Support Groups
`Rare diseases affect so few people that information about them may be difficult to find, making the
`situation more traumatic and stressful. Before Congress enacted the ODA, families coping with a
`rare disease usually struggled alone. Support could only be found through telephone calls to other
`families suffering with similar diseases, and only if the names were provided by doctors.
`Support groups such as the National Organization for Rare Disorders (NORD) have worked
`aggressively in the last 20 years to draw attention to people with rare diseases, and especially to
`the lack of treatment options. Paramount in NORD's ongoing cause are efforts to promote
`legislation, such as the ODA, that encourages further research and continuing development of
`products that are necessary--and often life-saving--and to provide easier access to such
`treatments.
`The role of the support group is evolving. Recent trends at the FDA and the NIH in encouraging
`scientists to become involved with patient support groups has brought research even further.
`New Web-based support groups continue to proliferate. Not only are people receiving comfort from
`others with the same conditions, but they are learning from each other's experiences as well. By
`the late 1990s, most nonprofit organizations had Web sites where people could ask questions and
`get immediate responses.
`Nevertheless, people diagnosed with a rare disease often are vulnerable to misguided assistance.
`While Stephen C. Groft, Pharm.D., director of the NIH's Office of Rare Diseases, encourages people
`to use the Internet to find information, he also warns that it is dangerous to rely solely on the
`computer for medical advice.
`"Be cautious about unproven remedies and miracle cures being touted over the Internet," he says.
`Too often misleading or inaccurate information is given out that can do more harm than good. In
`addition, one person's experience may vary greatly from another's. The Internet, he adds, should
`
`(cid:75)(cid:87)(cid:87)(cid:83)(cid:29)(cid:18)(cid:18)(cid:90)(cid:90)(cid:90)(cid:17)(cid:73)(cid:71)(cid:68)(cid:17)(cid:74)(cid:82)(cid:89)(cid:18)(cid:71)(cid:85)(cid:88)(cid:74)(cid:86)(cid:18)(cid:85)(cid:72)(cid:86)(cid:82)(cid:88)(cid:85)(cid:70)(cid:72)(cid:86)(cid:73)(cid:82)(cid:85)(cid:92)(cid:82)(cid:88)(cid:18)(cid:70)(cid:82)(cid:81)(cid:86)(cid:88)(cid:80)(cid:72)(cid:85)(cid:86)(cid:18)(cid:88)(cid:70)(cid:80)(cid:20)(cid:23)(cid:22)(cid:24)(cid:25)(cid:22)(cid:17)(cid:75)(cid:87)(cid:80)
`
`
`
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`
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`
`complement the communication between patients and their doctors, not replace it.
`
`(cid:41)(cid:82)(cid:85)(cid:3)(cid:48)(cid:82)(cid:85)(cid:72)(cid:3)(cid:44)(cid:81)(cid:73)(cid:82)(cid:85)(cid:80)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)
`Food and Drug Administration
`Office of Orphan Products Development
`(301) 796-8660
`http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm2
`National Institutes of Health
`Office of Rare Diseases, 6100 Executive Blvd., Room 3B01, Bethesda, MD 20892-7518
`(301) 402-4336
`http://rarediseases.info.nih.gov/3 National Cancer Institute
`Cancer Information Service
`(800) 4-CANCER (422-6237)
`www.cancer.gov4
`National Organization for Rare Disorders
`55 Kenosia Ave., PO Box 1968, Danbury, CT 06813-1968
`(800) 999-6673
`www.rarediseases.org5
`The Genetic and Rare Diseases Information Center
`PO Box 8126, Gaithersburg, MD 20898-8126
`(888) 205-2311TTY: (888) 205-3223
`www.genome.gov/health/6
`
`Page Last Updated: 03/15/2012
`Note: If you need help accessing information in different file formats, see Instructions for
`Downloading Viewers and Players.
`Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Site Map Transparency
`Website Policies
`
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`Ph. 1-888-INFO-FDA (1-888-463-6332)
`Contact FDA
`
`For Government For Press
`Combination Products Advisory Committees Science & Research Regulatory Information Safety
`Emergency Preparedness International Programs News & Events Training and Continuing
`Education Inspections/Compliance State & Local Officials Consumers Industry Health
`Professionals FDA Archive
`
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`1. /Drugs/ResourcesForYou/Consumers/ucm294868.htm
`2. /ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm
`3. http://rarediseases.info.nih.gov/
`
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`
`
`
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`
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`
`4. http://www.cancer.gov/
`5. http://www.rarediseases.org
`6. http://www.genome.gov/health/
`
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