Drug manufacturer Sanofi yesterday asked a federal judge in New Jersey to stay 340B administrative dispute resolution (ADR) proceedings against it brought by health centers seeking to overturn Sanofi’s restrictions on 340B pricing when covered entities use contract pharmacies.
Sanofi filed the motion for an emergency stay yesterday, Oct. 7. 340B Report broke the news yesterday that ADR panels have been assigned for certain proceedings. Sanofi says the U.S. Health Resources and Services Administration notified it on Oct. 5 that the ADR petition that the National Association of Community Health Centers (NACHC) refiled against the company last month has been assigned to an ADR panel for review. It said it appears, under the ADR rule, that it must respond to NACHC’s petition by Nov. 4.
Absent emergency relief from ADR proceedings similar to that granted by a federal district judge to Lilly, “Sanofi will be compelled to participate in an unconstitutional administrative process, even though the ADR Rule establishing that process is currently being reviewed by this court.”
Sanofi said the judge also could grant its pending motion for a preliminary injunction against enforcement of the ADR rule against the company.
NACHC said in a statement this morning that it is “disappointed, but not surprised by Sanofi’s attempt to thwart the 340B Alternative Dispute Resolution process.”
“For over 16 months, 340B grantees, like health centers, have been denied access to affordable medications for patients and critical savings to fund the delivery of comprehensive health care during a pandemic,” said NACHC Director of Regulatory Affairs Vacheria Tutson. “Sanofi’s last minute effort to delay the ADR process is another example of pharmaceutical manufacturers refusing to make a good faith effort to comply with the 340B program. On behalf of health centers, NACHC will continue to support the government’s efforts to protect the integrity of the 340B program and ensure that 340B covered entities can continue to use contract pharmacies to increase access for patients.”
Update Friday, Oct. 8, 2021, 4:30 p.m. Eastern—A Sanofi spokesperson provided this statement late Friday afternoon:
“Sanofi supports the 340B Program and its core objective of increasing access to outpatient drugs for uninsured and vulnerable populations and we remain committed to strengthening this mission. We share the government’s concerns about the unlawful duplicate discounting that has accompanied the explosion in covered entities’ use of contract pharmacies. This is why Sanofi launched an integrity initiative on October 1, 2020, under which Sanofi collects limited, de-identified, claims data on 340B-priced drugs dispensed by contract pharmacies. If a covered entity provides these data necessary to identify and prevent waste and abuse, then nothing will change. If a covered entity chooses not to provide the limited data, it will remain able to purchase 340B-priced drugs for shipment to its own facilities, including all community health centers with in-house pharmacies. Where a 340B covered entity does not have an in-house pharmacy, it may designate one contract pharmacy to which 340B-priced drugs will be shipped, regardless of whether the covered entity provides the limited data requested. These data will allow Sanofi to identify 340B-priced claims and to pay Medicaid and other insurers’ rebate invoices accurately. We continue to believe this integrity initiative complies with the 340B statute.”