Rx Drugs

HHS Secretary Alex Azar on Thursday (July 9) said the United States wants to make sure any vaccines it has invested in will be manufactured and distributed domestically to avoid relying on other countries.

Big brand-drug executives announced Thursday (July 9) that they’ve created a $1 billion fund to help small- to mid-sized companies develop breakthrough antibiotics because, they said, the market is broken and resistance to existing antibiotics is growing.

Regulatory experts say drug and medical device makers want more clarification about FDA’s view on decentralized clinical trials and how new flexible trial policies, including options for remote visits and monitoring, will be applied beyond the COVID-19 pandemic.

Stakeholders are closely watching to see whether FDA will cave to pressure from the White House and doctors and reinstate emergency use authorization for the anti-malarial drug hydroxychloroquine.

As White House officials tease a buy-American executive order, Joe Biden this week issued his plan for bringing pharmaceutical manufacturing back to the United States, and some of the general principles of the two plans overlap.

The American Civil Liberties Union says the Supreme Court’s recent 5­-4 decision to strike down Louisiana abortion restrictions boosts abortion care providers’ calls for FDA to remove prescribing and dispensing restrictions on the abortion pill mifepristone and shuts down the agency’s arguments that clinicians have no standing to assert patients’ rights to access the drug.

Novavax will receive $1.6 billion from HHS to make its COVID-19 vaccine candidate, and Regeneron Pharmaceuticals will receive $450 million to scale up production of its antibody candidate, HHS announced on Tuesday (June 7).

FDA on Monday (July 6) announced its plans to launch a two-phase study assessing how consumer and health care provider perceptions of a prescription drug are affected by certain disclosures in promotional materials, including information about a product’s biosimilar status and whether a drug may have additional clinical benefit based on secondary endpoints.

HHS officials told senators on Thursday (July 2) that clinical trial data from diverse populations, including racial and ethnic minorities, pregnant and lactating women, and children, will help inform the government’s COVID-19 vaccine distribution plan and ensure the vaccine is appropriately distributed among those in need.