Drug Pricing

The House Energy & Commerce Committee unveiled a number of draft 340B reform bills it will take up along with seven pending 340B bills at a health subcommittee hearing Wednesday (July 11), and while some of the draft legislation was expected, such as discussion drafts to change the definition of a patient and give the Health Resources and Services Administration more authority, one attorney said others appear to be messaging bills or focused on very narrow concerns.

The brand drug lobbies dropped Thursday (June 28) their lawsuit against Nevada’s insulin-price transparency law.

FDA announced Thursday (June 21) that the agency is withdrawing a draft guidance outlining the statistical approaches a biosimilar sponsor should use to demonstrate biosimilarity to a reference product.

The Health Resources and Services Administration's head of 340B, Captain Krista Pedley, told the Senate health committee on Tuesday (June 19) the agency could use additional authority to, among other things, track how providers currently use 340B savings and to define how those savings should be used.

The Senate Finance Committee will hold a hearing on President Donald Trump’s drug pricing plan June 26, the committee announced Tuesday (June 19). HHS Secretary Alex Azar is set to testify.

Congressional advisers for Medicare and Medicaid sent their June 2018 reports to Congress Friday (June 15) with expected recommendations on reducing Medicare payment rates for some emergency departments and strengthening the Medicaid Drug Rebate Program.

The Senate Judiciary Committee voted Thursday (June 14) 16-5 to advance the highly watched Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act without amendments to the Senate floor, but the path to a floor vote on the bill remains unclear.

American Medical Association delegates on Wednesday (June 13) asked the Justice Department and Federal Trade Commission to monitor insulin-pricing and -rebate practices of drug makers and pharmacy benefit managers, and the AMA plans to release a template for state legislators to reference as they write laws to lower insulin prices and ban so-called clawback fees and gag orders that pharmacy benefit managers impose on pharmacies.

FDA Commissioner Scott Gottlieb said he is discussing with CMS the possibility of a new license-based reimbursement model for antibiotics that would spare drug makers some of the disincentives that come with antibiotic development, such as the low volume of sales that occur when providers try to use antibiotics sparingly.