With a March 23 deadline approaching, Congress continues its work this week to finalize government funding levels that will be included in an omnibus appropriations bill that must be passed by next Friday.

As the legislative process moves forward, it is possible that a bipartisan bill in the House and Senate, known as the CREATES Act (S. 974/H.R. 2212) could be included. The act prohibits pharmaceutical companies from using restricted access programs as a way to avoid generic competition. Certain brand pharmaceutical companies prevent competition by blocking the ability of manufacturers to make more affordable generic and biosimilar alternatives. Click here for additional information.

A related bill, SB 75, passed during the recently completed South Dakota legislative session. The legislation established certain provisions regarding the dispensing of biological products.

In addition, the focus on 340B drug pricing program has increased on multiple fronts. The Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing March 15, while the House Energy & Commerce Committee has a hearing planned for later this spring. Sen. Charles Grassley (R-IA) introduced a bill intended to bring transparency to the 340B program by requiring participating hospitals to report the total acquisition costs for drugs, as well as revenues received from all third-party payers. While pharmaceutical companies are creating their offensive strategy against the program, we have joined together with the American Hospital Association (AHA) to emphasize the community benefit 340B hospitals provide. Lastly, oral arguments are scheduled for May 4 in the federal court of appeals on the 340B lawsuit.