IT Manufacturing Provider Referral 
FDA Law Blog
MAY 7, 2025
The Seventh Circuit took a more lenient approach than the Fourth Circuit, focusing its rationale on whether an independent contractor had improper influence over a healthcare providers independent healthcare decisions. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th
FDA Law Blog
NOVEMBER 6, 2022
Pfizer manufactures tafamidis (sold under brand names Vyndaqel and Vyndamax), a breakthrough treatment for a rare, progressive heart condition called transthyretin amyloid cardiomyopathy (ATTR-CM). If SCOTUS takes up this case, it could have significant and far-reaching implications across the healthcare fraud and abuse landscape. Background.
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FDA Law Blog
SEPTEMBER 29, 2021
The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.
FDA Law Blog
MARCH 31, 2025
C) REMEDIES IN ADDITION.Remedies provided in this paragraph are in addition to, and not in lieu of, any other remedy provided by Federal law. Under the Seventh Amendment and Jarkesy , a jury trial must be provided on liability before civil monetary penalties that are legal in nature can be assessed. 5) CIVIL PENALTY. (B)
FDA Law Blog
APRIL 2, 2025
C) REMEDIES IN ADDITION.Remedies provided in this paragraph are in addition to, and not in lieu of, any other remedy provided by Federal law. Under the Seventh Amendment and Jarkesy , a jury trial must be provided on liability before civil monetary penalties that are legal in nature can be assessed. 5) CIVIL PENALTY. (B)
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