Rx Drugs

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.

The House of Representatives passed 25 bills on Tuesday (June 12) that lawmakers say will help with the nationwide opioid crisis through a wide range of methods, from enhancing HHS and FDA’s seizure authority over imported drugs to amending the Public Health Service Act to provide for regional centers of excellence in substance-use disorder education.

The Senate Finance Committee unanimously approved a package of opioid-related legislation Tuesday (June 12) that would make modest tweaks to Medicare and Medicaid in hopes of reducing opioid abuse in those programs.

FDA finalized Tuesday (Jun 12) two guidances clarifying FDA’s rules for communicating health care economic information with payers and for promoting information that is consistent with, but absent from, a product’s label.

Rep. Doris Matsui (D-CA) on Tuesday (June 12) introduced a provider-friendly bill to reform the 340B drug discount program -- including explicitly laying out a purpose for the 340B program that says hospitals do not necessarily have to forward drug discounts to patients and reversing the CMS cut to hospitals' Medicare reimbursement for 340B drugs.

The Senate Finance Committee will mark up a legislative package Tuesday (June 12) intended to reduce opioid abuse in Medicare and Medicaid. The package released by committee Chair Orrin Hatch (R-UT) and ranking Democrat Ron Wyden (OR) includes measures to identify over-prescribing of opioids, increase awareness of alternative pain management, expand coverage of telehealth services for substance use disorders and bar lifetime limits on medication-assisted treatment in Medicaid.

Top House Energy & Commerce members from both parties raised concerns FDA is not following through on its plan to use $94 million from Congress to double down on efforts to keep illegal opioids from entering the United States through international mail facilities.