Focuses studies and requires guidance on physicians' and patients' understanding of the relative efficacy and effectiveness of drugs and biological products, particularly generic versions.
Amends the Federal Food, Drug, and Cosmetic Act to require the deposit into a Drug Reimbursement Fund of revenues earned by a patent holder during a period when a competitor was wrongfully enjoined from marketing a generic version.
Sets forth notice and publication requirements for agreements reached by a brand name drug company and a generic drug applicant concerning challenges to a patent certification.
Amends the title XVIII (Medicare) of the Social Security Act to include coverage for all oral anticancer drugs, regardless of the method of administration, under the Medicare current drug benefit. Requires the Medicaid Drug Use Review Program to provide for the distribution of generic drug samples of covered outpatient drugs to prescribers.
Addresses the relationship between prices charged for inpatient drugs at certain public hospitals and the best price exemptions established for the Medicaid Drug Rebate Program.
Requires that the national drug code for each drug be made available upon the publication of the upper payment limits for multiple source drugs under Medicaid.