Richie Davis and Michael French Quoted in 340B Report Article on HRSA’s Enforcement Threats for Unapproved 340B Rebate Model
Richie Davis and Michael French, attorneys in the Quarles & Brady Health & Life Sciences Practice Group, were quoted in a 340B Report article that discussed Health Resources and Services Administration’s (HRSA) enforcement threats against Johnson & Johnson for its unapproved 340B rebate model. Some people believe the HRSA has a strong cause again J&J, while others believe it could be more complicated for HRSA to impose any penalties.
An excerpt:
In addition, J&J may be able use the letter from HRSA and the Health and Human Services (HHS) to sue the government before any penalties are actually imposed, said Richard Davis and Michael French, attorneys at Quarles, which represents 340Bproviders and other program stakeholders. When HHS threatened enforcement against drugmakers for imposing contract pharmacy restrictions through letters in2020 and 2021, many manufacturers responded days later with lawsuits.
“Although the underlying facts differ, HHS’ letter sent to J&J is structured very similarly to the HHS warning letters sent to numerous manufacturers with restrictive contract pharmacy policies,” Davis and French said. “Thus, J&J may be able to use the letter in a similar manner to get the dispute in front of a judge, even before incurring penalties.”