This bill requires the Department of Health and Human Services (HHS) to review brand-name drugs annually for excessive pricing and, if a drug is found to be priced excessively, to void any exclusivity granted to its sponsor.
Specifically, HHS must review all brand-name drug prices at least annually and upon petition. If any such drugs are found to be excessively priced, HHS must (1) void any government-granted exclusivity; (2) issue open, nonexclusive licenses for the drugs; and (3) expedite the review of corresponding applications for generic drugs and biosimilar biological products. HHS must also create a public database with its determinations for each drug.
An entity accepting an open, nonexclusive license under these provisions must pay a reasonable royalty to the holder of the relevant patent or approved new drug application, and must price the generic drug or biosimilar below the excessive rate.
Under the bill, a price is considered excessive if the domestic average manufacturing price exceeds the median price for the drug in Canada, the United Kingdom, Germany, France, and Japan. If a price does not meet this criteria, or if pricing information is unavailable in at least three of these countries, the price is still considered excessive if it is higher than reasonable in light of specified factors, including development cost, revenue, and the size of the affected patient population.
The bill also requires drug manufacturers to report specified financial information for brand-name drugs, including research and advertising expenditures.