Affordable Prescription Drugs Act
This bill died when its Congress ended.
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Affordable Prescription Drugs Act - Amends Federal patent law to grant the Secretary of Health and Human Services the right to establish compulsory licensing (without authorization of the right holder) for nonexclusive, nonassignable use of certain patented medical inventions upon a determination that: (1) the patent holder, contractor, exclusive licensee, or assignee has not taken, or is not expected to take within a reasonable time, effective steps to achieve practical application of the subject invention in a field of use; (2) such compulsory license is necessary to alleviate health or safety needs which are not adequately satisfied by the patent holder, contractor, licensee, or assignee; or (3) the patented material is priced higher than may be reasonably expected based on criteria developed by the Secretary of Commerce. Requires any person engaged in the manufacture and sale of any new drug or new animal drug approved under the Federal Food, Drug, and Cosmetic Act, for which a patent is still in effect, to report annually to Congress an audit of all financial information relevant to that drug's pricing nationally and internationally, including research and development costs, sufficient to assess the reasonableness of that pricing. Requires disqualification from participation in Federal programs as a penalty for noncompliance with this reporting requirement.
Filed in the House
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