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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. At the time, in 2016, the Gree Companies’ settlement for $15.45 It involved Gree Electric Appliances Inc. of Zhuhai, Hong Kong, Gree Electric Appliances Sales Co.

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Recent Developments in the Medicaid Drug Rebate Program

FDA Law Blog

One of these amendments was a poorly thought-out rule that, if implemented, will render virtually unusable the current best price exclusion for manufacturer patient savings programs in the form of coupons, patient rebates/refunds, copay assistance, vouchers, and free drug programs. The effective date of this amendment is January 1, 2023.

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CMS proposes to Withdraw Trump Era Most Favored Nation (MFN) Drug Pricing Rule

FDA Law Blog

The idea of basing Medicare drug reimbursement on prices in foreign countries was first proposed during the Obama Administration in 2016. Use of international reference pricing as a target for Medicare to negotiate prices with drug manufacturers appears in H.R. The Trump Administration rule had a troubled history. 3 , the “Elijah E.

Finance 52
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Drug Pricing Reform Gathers Steam (Part 2)

FDA Law Blog

PART 1: MAXIMUM FAIR PRICE PAYMENT LIMITATION UNDER MEDICARE PARTS B AND D AND THE COMMERCIAL INSURANCE MARKET. The MFP would be established through negotiations between HHS and the manufacturer and would incorporate foreign pricing benchmarks, as further described below. The four parts of Subtitle E are summarized in turn below.

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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).