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FDA PUBLISHES ORPHAN DRUG REGULATIONS

 WASHINGTON, Jan. 4 /PRNewswire/ -- The Food and Drug Administration today announced final regulations to implement the Orphan Drug Act.
 "The orphan products program has been highly successful in helping people with rare diseases," said FDA Commissioner David A. Kessler, M.D. "The regulations will provide industry with guidance and further encourage development of treatments for these diseases."
 The regulations clarify FDA criteria for determining whether two similar drugs are different for purposes of the marketing exclusivity provisions of the act.
 Under the regulations, for example, a drug product composed of large molecules that contains the same principal "molecular structural features" as a previously approved orphan drug will be considered the same drug and not be approved for marketing for the same indication unless it can be demonstrated to show "clinical superiority."
 Clinical superiority may be demonstrated by greater effectiveness, safety, or in unusual cases, some other major contribution to patient care.
 The document reflects comments by patient groups, industry and health professionals on the proposals that were published on Jan. 29, 1991.
 Implemented under interim guidelines, the Orphan Drug Act has helped stimulate development of 65 products for 70 diseases; the final regulations will formalize these procedures.
 An orphan drug is defined in the law as a drug intended to treat a rare disease or condition that affects fewer than 200,000 people in the United States. Estimates are that as many as 20 million people in this county are affected by any of about 5,000 rare diseases, such as Tourette's syndrome, narcolepsy, muscular dystrophy and cystic fibrosis.
 The Orphan Drug Act was enacted in 1983 to promote the development and marketing of drugs, biologicals and other products to prevent or treat rare diseases. Products targeted at small patient populations often lack commercial appeal because the potential market is so small. The act provides various incentives, including seven years of exclusive marketing rights, to sponsors of orphan drugs who develop a product to the point of FDA marketing approval. The regulations were published on Dec. 29, 1992.
 FDA is one of the eight Public Health Service agencies within HHS.
 -0- 1/4/93
 /NOTE: TV broadcasters please use open caption for the hearing impaired./
 /CONTACT: Susan Cruzan of the Food and Drug Administration, 301-443-4177 or, after hours, 301-926-7081/


CO: Food and Drug Administration ST: District of Columbia IN: MTC SU:

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