Jill Wechsler, Pharm Exec’s Washington Correspondent

Medical device user-fees agreement, Aduhelm approval and access among issues in crosshairs.

Dual efforts focused on more inclusive research and more diverse enrollment in pre- and post-approval studies.

Transition likely with looming end to emergency use authorizations tied to COVID-19 pandemic.

Program looks to establish framework for agency and purchasers to “objectively rate” manufacturing sites.

Congressional bills put focus on comparator-drug access, more accurate trial and R&D cost determinations.

Several legislative initiatives on table that would extend agency’s reach.

IP claims under microscope amid arguments over R&D policy and investment.

Measures being mulled to reform the AA process and address public concerns around its risk-benefit payoff.

Quality metrics, more domestic production aim to avoid supply disruptions and drug shortages.

The US Congress approved a federal spending package that increases funding for a range of programs to advance health and medicine.

From supply-chain and clinical-trial disruptions in Ukraine and Russia, to decisions to halt investment or maintain operations, global implications for industry and pharmaceutical production are immense.

Agency clarifies stance on applications for ‘me-too’ drugs not supported by multiregional trials.

Pressurized political, COVID climates greet his return to top spot.

Agency restarts more routine site visits amid slowdown of new COVID infections.

Political issues delay Senate confirmation of Califf.

New package to clarify responsibilities for federal health agencies.

Uncertainty over experimental medicines calls for review of AA process.

International collaboration needed to address distribution hurdles.

In a highly unusual decision for a therapy approved by FDA, CMS has taken action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm.

Progress in 2022 will require nimble action across several fronts.

Despite major challenges and demands created by the coronovirus pandemic, FDA maintained a steady pace in 2021 in approving important new therapies for market.

On December 22, 2021, FDA authorized emergency use of Pfizer’s oral antiviral drug Paxlovid on December 22, 2021, skipping the advisory committee review to make the drug available as quickly as possible. The following day, FDA provided similar authorization for Merck’s Molnupiravir.

FDA has become embroiled in the debate over access to “chemical” or “medication” abortions through the prescribing and distribution of the abortifacient, mifepristone.

The Biden administration’s choice to lead FDA successfully navigated a Senate confirmation hearing on Dec. 14, setting the stage for full Senate approval early next year.

As Congress struggles to reach agreement on funding for leading social and spending initiatives and to avoid default on government borrowing, the White House is emphasizing that reduced spending on prescription drugs can help offset some of the steep costs.

New gene therapies for debilitating rare conditions stand to advance from an FDA collaboration with the National Institutes of Health and a cadre of pharma companies, small biotechs and patient groups.

Leading legislators have launched the campaign to enact a second version of the 21st Century Cures Act.

The White House nominates Robert Califf to once again take the reins of FDA, but acting commissioner Janet Woodcock will remain in place during the Senate confirmation process.

The Democratic proposal to authorize price negotiations on costly medicines covered by Medicare and to penalize firms that raise prices faster than inflation has drawn opposition pharma and biotech companies. More surprisingly, generic companies also are objecting to the changes on the table.

Democratic leaders in the House and Senate appear to have reached a compromise on a relatively modest plan for controlling prices on certain prescription drugs.