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Silence Isn’t Golden: Two Executives Convicted in First Criminal Prosecution Under the Consumer Product Safety Act

FDA Law Blog

(the “Gree Companies”), an appliance manufacturer and two of its subsidiaries that were involved in the manufacturing, marketing, and sale of dehumidifiers. According to the government, these companies knew as early as 2012 that their dehumidifiers were defective, in that they could overheat and catch fire.

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Drug Pricing Reform Gathers Steam (Part 2)

FDA Law Blog

This bill, which addresses numerous areas of the economy, public health, and government regulation, includes Subtitle E, Drug Pricing. PART 1: MAXIMUM FAIR PRICE PAYMENT LIMITATION UNDER MEDICARE PARTS B AND D AND THE COMMERCIAL INSURANCE MARKET. Subtitle E is a slightly modified version of H.R. 3, the Elijah E. 8126 with a lower MFP.

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Court Strikes Down CMS’s Accumulator Adjustment Rule That Threatened Manufacturer Patient Savings Programs

FDA Law Blog

By Faraz Siddiqui — Last June, we blogged about a lawsuit brought by the Pharmaceutical Research and Manufacturers of America (PhRMA) challenging CMS’s ill-conceived Accumulator Adjustment Rule (“final rule”), which amended the Medicaid Rebate best price regulation. On Tuesday, May 17, 2022, the D.C. See 42 C.F.R. §§ 447.505(c)(8)-(12).