Orphan Drug Act

(House agreed to Senate amendment with an amendment)

Orphan Drug Act - Amends the Federal Food, Drug, and Cosmetic Act to allow sponsors of a drug for a rare disease or condition (orphan drug) to request the Secretary of Health and Human Services to provide written recommendations for the non-clinical and clinical investigations which must be conducted with the drug before: (1) it may be approved as a new drug under such Act; or (2) it may be licensed as a biological product under the Public Health Service Act. Authorizes the Secretary to provide such recommendations on the basis of available information on whether such drug is for a disease or condition which is rare in the United States.

Directs the Secretary to designate orphan drugs and notify the public of such designation if the sponsors of such drug conform to provisions of this Act.

Prohibits the Secretary from approving any other applications or issuing any other licenses for an orphan drug until seven years after the initial application or license approval date, unless: (1) the sponsors cannot assure the availability of sufficient quantities of such drug; or (2) the sponsors consent in writing to the approval of other applications or licenses.

Requires the Secretary, if a designated orphan drug is being used solely for research purposes, to encourage its sponsors to design protocols for human clinical investigation for individuals who require its treatment because there is no satisfactory available alternative.

Amends the Public Health Service Act to establish the Orphan Products Board (Board) in the Department of Health and Human Services to promote and coordinate the development of orphan drugs and devices. Requires the Board to submit an annual report to the appropriate congressional committees which identifies the designated orphan drugs, describes the Board's activities, and contains results of its evaluations. Requires the Director of the National Institutes of Health and the Administrator of the Alcohol, Drug Abuse, and Mental Health Administration to include in such report a report on their research activities respecting orphan drugs.

Amends the Internal Revenue Code of 1954 to allow a tax credit equal to 50 percent of the qualified experimental expenses paid or incurred by a taxpayer for certain drugs for rare diseases or conditions. Allows a deduction for the remaining 50 percent of such expenses.

Requires inclusion of a report on the use of such tax credit in the Board's annual report to Congress.

Authorizes appropriations for FY 1983 through FY 1985 for grants or contracts to assist eligible entities to defray costs of qualified experimental expenses.

Amends the Public Health Service Act to authorize the Secretary of Health and Human Services to make grants to public and nonprofit private entities and loans to proprietary entities to meet the initial costs of establishing and operating home health programs. Authorizes such grants and loans to include funds to provide training to professional and paraprofessional personnel to provide home health services.

Directs the Secretary, in making such grants and loans, to: (1) consider the relative need of a State for services; and (2) give preference to areas with a high percentage of elderly, indigent, or disabled individuals.

Requires a proprietary entity to assure that it: (1) is fiscally sound; (2) is unable to obtain the loan from non-Federal lenders at prevailing interest rates; and (3) will remain fiscally sound during the period of the loan.

Authorizes appropriations for FY 1983 and 1984 for such loans and grants.

Authorizes the Secretary to make grants to public and private entities to assist them in developing appropriate training programs for paraprofessional personnel to provide home health services.

Authorizes appropriations for FY 1983 and 1984 for such training grants.

Directs the Secretary to report to specified congressional committees on: (1) the impact of grants and loans made under this Act; (2) the need to continue such grants and loans; and (3) the extent to which standards have been applied to the training of personnel.

Requires the Secretary to report the results of studies currently evaluating home and community based health services, and recommendations for legislative action, prior to January 1, 1985.

Directs the Secretary to compile and analyze the results of significant studies carried out by public or private entities relating to methodologies for home health services. Requires the Secretary to make recommendations to Congress with respect to such methodologies.

Directs the Secretary to investigate and report to Congress on methods to stem fraud abuse.

Directs the Secretary to develop and carry out demonstration projects testing alternative reimbursement methodologies for home health services and methods for identifying patients at risk of institutionalization who could be better treated with home health services. Requires a report to Congress on such projects not later than January 1, 1985.

Directs the Secretary to conduct scientific research and prepare analyses necessary to develop valid assessments of the risks of thyroid cancer associated with thyroid doses of Iodine 131, especially as a product of nuclear fallout. Requires the Secretary to report to Congress within one year of enactment on the results of the study.

Requires the Secretary to develop radioepidemiological tables which will catalog for each radiogenic cancer the probability that a given dose of ionizing radiation caused the cancer of a victim who has received such a dose.

Makes technical and conforming amendments to the Omnibus Budget Reconciliation Act of 1981 and the Public Health Service Act.

Makes funds available under the Energy Security Act for a study of the water quality of the Quabbin Reservoir in Massachusetts.

Requires extension of the patent on any composition of matter or a process for using such composition which was reviewed by the Federal Food and Drug Administration but for which a stay of regulation of approval was imposed and in effect on January 1, 1981.