Even as many in the U.S. are looking for the end of the COVID-19 public health emergency, Health and Human Services (HHS) Secretary Xavier Becerra reinforced expectations April 5 that he will continue the emergency declaration into the summer, if not beyond. When asked during a Senate Finance Committee budget hearing if he saw the emergency ending this summer, Becerra declined to give a date, but reiterated his commitment to give stakeholders at least 60 days’ notice.

The Biden administration has floated a budget proposal for fiscal year 2023, which includes $49 billion for the National Institutes of Health (NIH) and an additional FDA budget authority of $356 million over the current fiscal year. However, the budget also includes legislative proposals, such as a virtual inspection requirement for device manufacturing facilities and compulsory studies of drug shelf life to evaluate finished drug stability beyond the labeled expiration.

Disagreement over offsets for an additional $15.6 billion in COVID-19 funding forced the supplemental pandemic funds recently requested by the White House to be cut from the fiscal 2022 spending bill, so the U.S. House would have the votes to pass the $1.5 trillion omnibus spending package late March 9.

When the U.S. Congress resumes next week, its top priority will be the passage of a massive budget bill that once again includes long-promised – or threatened, depending on a person’s perspective – provisions intended to bring down prescription drug prices.

In an effort to advance a fiscal 2022 spending package through a divided Congress, U.S. President Joe Biden released the framework for his Build Back Better agenda Oct. 28 – minus provisions that would allow Medicare to directly negotiate at least some prescription drug prices.

As the U.S. House of Representatives resumes work Aug. 23 on a budget reconciliation proposal to get a $3.5 trillion fiscal 2022 budget across the finish line, many lawmakers are looking to provisions to reduce prescription drug prices as a way to pay for increased spending in other health care sectors.

The U.S. House Appropriations subcommittee passed an appropriations bill for the FDA that would add $257 million to the agency’s budget authority for fiscal year 2022, an increase of 8% over the currently enacted level. The Alliance for a Stronger FDA said in a June 25 statement that it will work to ensure the Senate comes up with similar numbers, characterizing the push to fully fund the agency as “a multi-year marathon, not a sprint.”

The Biden administration released its full budget proposal for fiscal year 2022, increasing the FDA’s budget authority to nearly $3.6 billion, up 10% over 2021. The Alliance for a Stronger FDA said that though analysis is needed to parse out the details, the proposal will be supported.

The May 25 appearance of Francis Collins, director of the U.S. National Institutes of Health, before a congressional committee revolved in large part around the Biden administration’s so-called ARPA-H proposal, but the administration’s proposal to waive intellectual property rights for vaccines was also on tap.