11/30/2021 | News release | Distributed by Public on 11/30/2021 09:52
The individual cases at issue are:
The cases address common questions concerning the interpretation and implementation of the 340B Statute:
Additionally, one case addresses the validity of the so-called "ADR rule" that HRSA was required to issue under the Affordable Care Act back in 2010, but did not promulgate until December 2020. The ADR Rule sought to create an administrative dispute resolution mechanism to resolve disputes between participating manufacturers and Covered Entities related to the 340B program.
Fundamentally, these cases highlight HRSA's piecemeal, and at times, conflicting interpretation of the 340B Statute. They also demonstrate the limitations the agency faces given the authority provided to it by Congress under the 340B Statute. Those familiar with the 340B Program and the 340B Statute know that fulsome implementing regulations are scant, in part because HRSA's statutory authority to promulgate regulations is limited to two distinct areas: (i) imposing civil monetary penalties on participating manufacturers for failing to offer the 340B Ceiling Price to Covered Entities, and (ii) creating an administrative dispute resolution process. Given these limitations, Covered Entities and participating manufacturers alike have been forced to rely upon guidance issued by HRSA in the form of notices in the Federal Register, letters to program participants, and other less formal means. At times - such as with respect to the use of contract pharmacies - the agency has altered its view and position, creating confusion and diverging interpretations of the 340B Statute by parties impacted by the statute.
We have summarized the key takeaways from the four cases in the chart below:
Case |
Order / Opinion Issued |
HRSA Authority |
ADR Rule |
OIG Advisory Opinion |
Enforcement Letter |
Case Status |
AstraZeneca |
(with link to Opinion) |
Does not directly address the bounds of HRSA authority, but notes that agency's interpretation of manufacturers' obligations has "evolved" over time |
Not addressed in action before the court |
Denied HHS' motion to dismiss and held that Advisory Opinion is "legally flawed" because it wrongly interprets "unambiguous" statutory language |
Not addressed in action before the court |
Cross motions for summary judgment before Judge Stark; joint status report filed Nov. 11, 2021 |
Eli Lilly |
Oct. 29, 2021(with link to Order) |
Court upheld HRSA's authority to interpret the statute in a manner that restricts drug manufacturers' ability to impose extra conditions on Covered Entities |
Not addressed in action before the court |
Vacated; not remanded since HHS Office of Inspector General (OIG) voluntarily withdrew Opinion; court held it was arbitrary & capricious and violated Administrative Procedures Act (APA) |
Vacated as arbitrary & capricious and violated APA, but not beyond HRSA authority; remanded to HRSA; HRSA can decide whether to re-issue/hand over to OIG to potentially impose CMPs |
Appealed to Seventh Circuit, Nov. 16, 2021 |
Sanofi-Aventis & Novo Nordisk |
Nov. 5, 2021(with link to Opinion) |
HRSA has statutory authority to require shipment to at least one contract pharmacy, regardless of manufacturer policy |
Did not violate the APA, or Articles II or III of the Constitution |
Motion for summary judgment denied as moot since OIG voluntarily withdrew Opinion |
Vacated and remanded both letters, but not held to exceed HRSA authority; HRSA can decide whether to re-issue/hand over to OIG to potentially impose CMPs |
Appealed to Third Circuit Nov. 19, 2021 |
Novartis & United Therapeutics |
Nov. 5, 2021(with link to Opinion) |
Conflicting holding from the court; found that HRSA's interpretation that manufacturers cannot impose any conditions as improper; yet would not hold that manufacturers' policies were expressly "permissible under Section 340B" |
Not addressed in action before the court |
Not addressed in action before the court |
Vacated both letters, but denied injunctive relief and did not hold that manufacturers' policies were expressly "permissible under Section 340B" |
No appeal filed as of Nov. 30, 2021 |
It is important for participating manufacturers to note that these cases are far from final. Eli Lilly and Sanofi have already appealed. There are other cases brought by other participating manufacturers pending. In addition, at least with respect to the Enforcement Letters, HRSA may reissue letters and ask OIG again to seek civil monetary penalties from manufacturers for failing to offer the ceiling price due to their non-recognition/restrictions on contract pharmacies. Currently, no CMPs have been imposed related to this issue, nor has OIG brought administrative action seeking CMPs yet.
Participating manufacturers contemplating changing current policies or procedures addressing 340B purchases should be sure to consult legal counsel before amending current practices. And stay tuned as the saga continues!