The AAMC sent an April 16 letter (PDF) to Rep. Doris Matsui (D-Calif.) endorsing the 340B Pharmaceutical Access to Invest in Essential, Needed Treatments and Support Act (340B PATIENTS, H.R. 7635). The bill, which is also supported by the American Hospital Association, 340B Health, and others, would address pharmaceutical manufacturers’ restrictions on 340B covered entities’ use of community-based “contract pharmacies” to distribute covered outpatient drugs.
In 2020, six manufacturers announced their decision to restrict access to 340B discounts for 340B-eligible drugs dispensed at contract pharmacy locations, prompting the Health Resources and Services Administration to issue letters informing them that they are in “direct violation of the 340B statute” [refer to Washington Highlights, May 21, 2021]. In response to these letters, several manufacturers sued the federal government, contending that the 340B statute is silent with respect to covered entities’ ability to use contract pharmacy arrangements. Litigation related to this matter is ongoing.
The 340B PATIENTS Act would amend the statute to codify covered entities’ ability to use contract pharmacies to distribute 340B-acquired drugs, prohibiting manufacturers from imposing limits or conditions on these arrangements. In its letter, the association applauded these protections, noting, “The 340B PATIENTS Act would safeguard the 340B program, ensuring that it can continue to benefit safety-net providers, patients, and communities long into the future.”