Lawsuits are piling up against an HHS advisory opinion that drugmakers must provide steep discounts to pharmacies in contract with low-income health providers.
The opinion, by Department of Health and Human Services General Counsel Robert Charrow, isn’t legally binding. But companies allege it’s unlawful and puts them on the hook for honoring a practice they say falls beyond the scope of the program. They also fear that a newly established alternative dispute resolution board for 340B spats will rely on the opinion when making its decisions.
Because the ADR panel will consist of HHS representatives, it “will treat the Advisory Opinion as binding in any ADR proceeding, almost certainly find that Sanofi’s integrity initiative violates Section 340B as interpreted by HHS, and potentially impose crippling sanctions,” Sanofi said in a lawsuit filed with the U.S. District Court for the District of New Jersey.
The legal challenges fit into a broader battle waged over the reach of the federal 340B program. Drug companies in recent months have reduced the number of pharmacies allowed access to drug discounts to narrow a program they call overgrown and fraught with abuse.
Drugmakers say their actions are meant, in part, to cut back on giving discounts for the same drug twice. But health centers say that if drugmakers continue to remove pharmacies from their discount list, the financial loss will be disastrous to the facilities and patients that depend on them.
Other major drug companies are considering bringing their own lawsuits against HHS over the advisory opinion, an individual familiar with the matter said.
An HHS spokesperson said the agency doesn’t comment on pending litigation.
Covered entities “had long expected drug manufacturers to take aggressive action to limit the scope of the 340B program,” said
“This is just another opportunity for them to voice their objection to the 340B program as a whole,” Cook said.
AstraZeneca argues “the widespread proliferation” of arrangements with contract pharmacies has “transformed the 340B program from one intended to assist vulnerable patients into a multi-billion-dollar arbitrage scheme that benefits national for-profit pharmacy chains and other for-profit intermediaries,”according to its complaint filed in the U.S. District Court for the District of Delaware.
Drug companies believe that the law is on their side.
Nothing in the 340B “statute allows, let alone mandates, the use of contract pharmacies or that manufacturers respect an unlimited number of covered entity—contract pharmacy relationships. In fact, the opposite is true,” Eli Lilly said in its own complaint filed in the U.S. District Court for the Southern District of Indiana.
The Charrow opinion forces the company “to forego billions of dollars in revenue generated by its participation in the 340B Program” in order to get coverage and reimbursement from the government, Eli Lilly added.
Meanwhile, health centers have taken action to stop drug companies from scaling back discounts.
A group of HIV-AIDS clinics sued the HHS to force Eli Lilly, AstraZeneca, and
The National Association of Community Health Centers, in a separate lawsuit in October, sued the HHS for failing to implement a mechanism to resolve discount disputes. The HHS released a final rule Dec. 10 to create such a mechanism, which was scheduled to take effect Wednesday.