Orphan Drug Act

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 90 percent of the qualified experimental expenses paid or incurred by a taxpayer for certain drugs for rare diseases or conditions.

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