Contract Legal Manufacturing Statute 
FDA Law Blog
MARCH 24, 2024
By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. Code Ann. § 23-92-604(c)(1), (2) (Act 1103).
FDA Law Blog
NOVEMBER 7, 2021
Kirschenbaum — On September 30, we blogged about the ongoing dispute and litigation around the use of contract pharmacies under the 340B Drug Discount Program (click here ). A key issue before the court was whether, despite the relevant statute’s silence on the issue, Congress intended to allow the use of contract pharmacies.
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FDA Law Blog
FEBRUARY 5, 2023
By Faraz Siddiqui — In the Spring of 2021, the Health Resources and Services Administration (HRSA) threatened six drug companies with billions of dollars in penalties for not providing 340B discounts to covered entities that sell drugs through vast networks of contract pharmacies (more background on earlier posts ). A lot is at stake here.
SCOTUSBlog
MARCH 15, 2024
Share As a specific legal question, Tuesday’s bankruptcy case is simple, almost trivial: whether the Bankruptcy Code provisions that permit any “party in interest” to “be heard on any issue” in a Chapter 11 proceeding extend to an insurance company obligated on the claims against an asbestos company during the latter’s reorganization.
Patently O
FEBRUARY 10, 2022
2015) in finding that manufacture and delivery of a product in a foreign country can infringe a US patent if sufficient sales-activity occurred within the US. The recent Federal Circuit decision in Caltech v. Broadcom includes an important discussion of extraterritorial damages further extending Carnegie Mellon (Fed. Broadcom Ltd.
FDA Law Blog
OCTOBER 4, 2023
As such, that statute was unjust, confiscatory and violated their constitutional due process rights. Because Plaintiffs are not legally compelled to participate in the Program—or in Medicare generally—they have not shown a strong likelihood of success on the merits of their due process case.” Order at 24.
FDA Law Blog
JUNE 12, 2022
Walsh — Legal doctrines can be like parrots. Under the False Claims Act (FCA), if a company’s fraudulent conduct induces a governmental entity to enter into a contract with the company, then any claims for payments under that contract are false. established by statute and case law. By Jeffrey K. Shapiro & Anne K.
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