Rx Drugs

The White House released an executive order Sunday evening (Sept. 13) that extends the president’s controversial most-favored nation policy to include Medicare Part D in addition to Part B, a move that could eventually drastically lower seniors’ drug costs but that policy experts view as a Hail Mary before the election and expect to be challenged in court.

The president’s executive order aimed at making insulin affordable for low-income diabetics would do the opposite in some circumstances, and the order violates the law that governs community health centers, health center representatives told White House officials in a private meeting Wednesday (Sept. 9).

FDA will apply a so-called emergency use authorization-plus standard to COVID-19 vaccine review that leans closer to requirements for a full biologics license application, agency biologics center chief Peter Marks said Thursday (Sept. 10).

More than 1,100 hospitals across the country are stepping up pressure on HHS Secretary Alex Azar to stop drug makers from limiting 340B discounts via contract pharmacies or tying those discounts to claims data submissions, telling Azar in a letter Thursday (Sept. 10) that the manufacturers are taking away discounts on some of the costliest cancer and diabetes drugs.

The House Energy & Commerce Committee on Wednesday (Sept. 9) sent to the House floor a bipartisan bill that would require FDA and the National Institute on Drug Abuse to issue guidelines on the production of marijuana, as part of the legislation’s larger goal to make marijuana accessible to researchers for medical purposes.

Pharmacists will be allowed to administer COVID-19 vaccines to anyone three years or older without a prescription, according to guidance HHS issued Wednesday (Sept. 9).

The United States Pharmacopeia (USP) and FDA last week published guidances that address how drug makers and suppliers can check drug products for the presence of nitrosamines, and reduce or prevent the level of nitrosamines in finished products.

Community health centers are prepping legal action in a bid to avert drug manufacturers’ limitations on 340B discounts accessed via contract pharmacies, as two hospital groups also consider their legal options and the Health Resources and Services Administration weighs whether manufacturers’ policies violate the 340B statute and sanctions should apply.

Former FDA chief Margaret Hamburg expressed confidence that FDA and other global regulators will follow the science when deciding whether to approve a COVID-19 vaccine, and she joined other current and former public health officials in calling for increased reliance on international regulators to make sure coronavirus vaccines are distributed equally around the globe.