Jill Wechsler

FDA and industry face unprecedented political and policy challenges.

The agency will be reorganizing field force and compliance functions.

Manufacturer lawsuits prompt CMS to [slightly] modify pricing plan.

Pandemic, PBM, and other policies on hold during the summer recess.

FDA's approval of Leqembi paves the way for wider coverage of the drug by Medicare and establishes a process for further clinical testing and evaluation of treatments for this widespread, debilitating condition

Problems continue despite actions by regulators to better prevent and address drug shortages.

There is concern that debates will delay the five-year reauthorization of PEPFAR under review by Congress.

Reimbursement for Alzheimer's medicines still will occur only with the completion of studies to support full FDA approval.

FDA has published a new system for providing basic and essential information on patient use of drugs and certain biologic products.

An increase in applications for gene therapies is putting stress on FDA’s resources.

Challenges to approval decisions have prompted FDA officials to reexamine of the role and composition of the agency’s many advisory committees and to explore options for change.

Congress have initiated a range of legislative proposals to further manage PBMs and the pharma market.

FDA is encouraging sponsors to conduct studies and file applications for full approval of products authorized by Emergency Use Authorizations.

The Supreme Court’s action leaves open the prospect of further rulings that could undermine FDA’s approval process.

Will court challenges to FDA’s oversight authority open the door for multiple lawsuits to block agency decisions on all sides?

The agency is dealing with high demand for staff because of a surge in the development of cell and gene therapies.

FDA aims to address mounting criticisms of its accelerated approval pathway.

FDA has spurred investment to create and develop 600 therapies.

A new Interagency Working Group for Bayh-Dole will review the government’s authority to revoke licenses for medical products.

Even after an FDA advisory panel voted 14–1 in October 2022 to remove the drug, Makena manufacturer Covis Pharma continued to press for some continued access to the therapy.

Congressional leaders are investigating how pharmacy benefit managers determine health plan coverage and charges for medicines.

Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.

GAO calls for more oversight of institutional review boards in clinical trials.

After years of FDA issuing guidance documents and launching programs to encourage sponsors to seek broader representation in clinical trials, policy makers have added a “stick” to the process.

Biden outlined a host of priorities for improving health care and building the economy during State of the Union address.

A realignment of the Office of Regulatory Affairs would create a focus on “critical activities” for ensuring the safety of foods and other regulated products, including drugs, biologics, and medical devices.

A Congressional probe of FDA’s approval of Alzheimer’s treatment targets the agency’s interactions with drug manufacturers.

FDA will restart in-person, face-to-face meetings with industry sponsors beginning Feb. 13, 2023, after a shift to all-virtual meetings during the pandemic.

FDA plans to authorize a common bivalent shot that targets both the original COVID-19 strain and Omicron subvariants.

The agency revised a regulation to enable pharmacies to dispense mifepristone directly to individuals with a prescription.