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

FDA Law

(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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MN Legislative Session 2025: Updates on Health Care Bills

Minnesota Academy of Family Physicians

Committees reviewed a range of legislation, including efforts to address workforce shortages, expand insurance coverage and improve school health services. The bill passed by a voice vote and was referred to the State and Local Government Committee. Read a summary of S.F. The bill supports a coordinated approach to services.

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4th Circuit En Banc Judgment Affirms District Court Decision in Best Price Stacking Case

FDA Law

The 4th Circuit three-judge panel decision relied heavily on the Supreme Court’s decision in Safeco Insurance Co. The controversy over the FCA’s intent standard where the applicable statute or regulation is ambiguous has special relevance when the FCA is used to target inaccurate government price calculations. of America v.

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Drug Pricing Reform Gathers Steam (Part 2)

FDA Law

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

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).

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Biden “Promoting Competition” Executive Order Falls In Behind Drug Importation

FDA Law

Two states have submitted importation plans to FDA for approval, but the rule and the certification were promptly challenged in federal court by the Pharmaceutical Research and Manufacturers of America (PhRMA) and other interest groups. Among the Order’s mandates for DHHS are several relating to prescription drugs.

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Even with Short-Term Health Insurance, his Colonoscopy Bill was $7,000

Physicians News Digest

By Julie Appleby Tim Winard knew he needed to buy health insurance when he left his management job in manufacturing to launch his own business. After speaking with an insurance agent, he decided against enrolling in an Affordable Care Act plan because he was concerned about the potential cost. Then the bill came.