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.
FDA Law Blog
MAY 7, 2025
Seventh Circuit ruling in Sorensen In Sorensen , the government alleged, and the District Court agreed, that Sorensen paid illegal kickbacks to marketing firms based on the number of leads generated and a DME manufacturer based on the percentage of funds collected from Medicare. Medicare or Medicaid). Polin , 194 F.3d 3d 863 (7th Cir.
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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
The latest iteration of proposed Section 27 in S. But then come the newly revised penalties provisions: (4) CIVIL ACTION.In 5) CIVIL PENALTY. Those penalties are clearly legal in natureand therefore trigger the Seventh Amendment under Jarkesy because they are punitive treble penalties. Further, S. Second , S. Attorney General (USAG).
FDA Law Blog
APRIL 2, 2025
The latest iteration of proposed Section 27 in S. But then come the newly revised penalties provisions: (4) CIVIL ACTION.In 5) CIVIL PENALTY. Further, S. 1096 specifically permits the FTC to continue to use its administrative process to determine that a company has violated the new rules on settlements.
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