Rx Drugs

While health care costs for a family of four dropped 4.2% in 2020, spending on retail prescriptions drugs remained strong as mail order drug delivery surged and drug prices increased, according to the Milliman Medical Index.

FDA is not close to letting states import Canadian drugs, according to the Biden HHS’ response to PhRMA’s lawsuit against the Trump-era rule, and even if FDA were to allow imports, the Canadian government might not allow exports.

The National Institutes of Health on Tuesday (June 1) started a phase 1/2 clinical trial to test the safety and immunogenicity of giving a booster shot of Moderna’s COVID-19 vaccine to adults who have already been immunized with one of the three other COVID-19 vaccine regimens currently authorized by FDA.

In its fiscal 2022 budget justification released Friday (May 28), FDA identifies several legislative proposals it says could help with the agency’s COVID-19 pandemic response, including by giving FDA authority to require specific medical device supply chain information, request facility records in advance or in lieu of inspections, and share medical product information with state and local governments.

FDA on Wednesday (May 26) granted emergency use authorization to GlaxoSmithKline’s investigational monoclonal antibody, sotrovimab, for treatment of patients with mild-to-moderate COVID-19.

HHS and FDA officials announced Wednesday (May 26) that they are reversing a Trump-era directive to eliminate FDA’s Unapproved Drugs Initiative through which the agency has tried to remove from the market any unapproved drugs. The officials say the Trump administration’s November attempt to withdraw the unapproved drugs program was “legally and factually inaccurate.”

Moderna announced Tuesday (May 25) that it will soon ask FDA to clear the company’s COVID-19 vaccine for use in teens ages 12 to 17, coming as clinical trial data show the vaccine was 100% effective in teens.

Former FDA chief Scott Gottlieb and former HHS Assistant Secretary for Health Brett Giroir sparred over the safety of kratom and who’s to blame for the lack of strict scheduling, coming just minutes after FDA announced the seizure of $1.3 million worth of kratom-containing dietary supplements and bulk dietary ingredients.

An amendment introduced in the Senate would curtail the Office of the U.S. Trade Representative’s authority to move ahead with World Trade Organization talks on a proposed waiver of certain intellectual property obligations through added “deliberation, transparency, and reinforced congressional oversight” provisions, according to Senate Finance Committee ranking member Mike Crapo (R-ID).