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Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

FDA Law

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. Eligible patients would be responsible for only $35 per month, and Pfizer would cover the rest of the approximately $13,000 annual copay. Background. Pfizer appealed to the Second Circuit.

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Green Practice News: May 2025

My Green Doctor

This isn’t just about saving the planet—it’s also about saving money, protecting patients, and strengthening our healthcare systems from the inside out. Latest news & breaking headlines And, in many countries, governments offer financial incentives to install solar panels and even backup batteries.

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Biased research, aggressive sales, harmful drugs

The Health Policy Exchange

Food and Drug Administration to market a new drug is a critical waypoint along the path to profits for pharmaceutical manufacturers. Very quickly, the market included nearly all dialysis patients, not just the roughly 16 percent who required blood transfusions. Approval from the U.S. The size of average doses would more than triple.

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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.

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FDA Approves First State Drug Importation Program Under 20-Year-Old Statute, But High Hurdles Remain

FDA Law

This request must provide details about, among other things: The foreign seller that will purchase the prescription drug directly from its manufacturer, along with invoices, batch, and lot/control numbers to verify the sale and the units sold. The government would require at least another 30 days to examine the shipment at the U.S.