Court sides with drug manufacturers in pending 340B dispute

Over the past year, covered companies participating in the 340B Drug Program (340B Program) have enthusiastically reviewed a number of lawsuits that could determine the grade of the 340B Program.

It was multiple pharmaceutical companies that filed a lawsuit against the related enforcement service which, as of 2020, stated that 340B of the discontinued funds would no longer be available for their drugs when the drugs were distributed through the provision of insurance agents. . And pharmaceutical companies or, in some cases, to reduce the companies covered by 340B in processing in a single pharmaceutical market.

Last week, a regional court upheld one of the pharmaceutical manufacturers and rejected a government motion to remove it, concluding that Law 340B does not support the use of 340B pharmaceutical hospitals. In response, the Government issued a statement stating that, although it did not agree with the court’s decision, it was rejecting the decision of its former counselor in favor of the use of drug trafficking, although coercive actions against those who develop drug development will continue.

Action Agency supports the acquisition of price 340B

The federal government opposes actions by pharmaceutical companies to reduce the 340B fee for the pharmaceutical market. The 340B Program Management, Health and Services Administration (HRSA) company guidance allows 340B companies to cover 340B medications from one or more pharmacies. On December 30, 2020, the Office of the General Counsel of the Department of Health and Human Services (HHS) issued Resolution 20-06 (Recommendation), in which it is concluded that the manufacturers of pharmaceutical products will deliver prescription drugs to cover more than 340B for rent for pharmacists. Call the hospitals that operate as insurance carriers.

Additionally, HRSA sent six letters (broken letter) to six pharmaceutical manufacturers on May 17, 2021, announcing that manufacturers’ plans to avoid acquiring a value of 340B to cover operating companies by delivering drug-covered treats. Pharmacists “have made them more expensive and in violation of rule 340B.” The damage letter asked the manufacturers to respond by June 1, 2021, on plans to fix those costs, pay off the debt and threaten the local financial penalty.

Additionally, in January 2021, HRSA announced a long-awaited final regulation to establish a Career Decision Regulation (ADR) system that would listen to price disputes between pharmaceutical manufacturers and covered companies.

Ongoing Litigation

Many drug companies, as well as drug groups, have accused the government of a Decision of Discrimination (APA) or a statement from a recent ADR law that violates the APA, and in some cases, pharmacists file accusations related to the Defense Statement and the final ADR. Politics. While any prosecution is similar, the practice has not been hampered by various federal courts.

In addition to the Agency’s work, 340B companies have filed a series of lawsuits against the HHS secretary demanding that a comprehensive mechanism be put in place that allows the company to cover and settle manufacturers’ invoices. These cases have been withdrawn following HRSA’s declaration of the latest ADR rule, which is currently being challenged.

District Court Decision

On June 16, 2021, a federal judge at the U.S. District Court for the District of Delaware issued an opinion rejecting a federal appeal to dismiss the case of one of the pharmaceutical companies and consider the details of each section on how Rule 340B applies to pharmaceutical contracts. In his opinion, the court focused on the fact that the law does not regulate “whether insurance must be available to the pharmacy for the purchase of profitable drugs from manufacturers, or if the company is covered it can buy outside other pharmacies And he concluded that, since the law is not clear, the Government’s clarifications are not the only acceptable ones.

Based on decision making

Following the court’s opinion, the Office of the General Counsel (OGC) submitted by HHS on Friday, June 18, 2021 (Note) that the majority of the pending pharmaceutical manufacturers are not involved in the case to withdraw the Advisory Opinion “due to a further confusion about the scope and impact of the Decision.”(See Disposal Description, shown above). “Finally, the OGC stated that continued compliance efforts by the HRSA under Rule 340B will have no effect on the Level “including the HRSA of May 17, 2021, regarding the limitation of application in the trade agreement of drugs. HRSA’s enforcement system operated independently of the externality of the Resolution, and it operated independently of the exclusion of the Resolution. “

The District Court’s opinion that exclusion from an attorney’s decision does not resolve the current dispute over 340B’s availability of company-covered and pharmacy-bought drugs.

Next steps

As stated in the Declaration, the decision of a regional court (which refuses to dismiss an appeal) will not resolve the current dispute over the acquisition of a price of 340B for the drugs covered by the pharmaceutical market company. Foley attorneys are reviewing ongoing developments to help covered companies understand their future impact, or recurrence, of acquiring the value of 340B.