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A broad White House proposal to advance competition in major U.S. industries features several measures intended to make medicines more affordable for patients.

Drug Prices Targeted in Biden Competition Initiative

FDA acting commissioner Janet Woodcock has bowed to pressure and called on the HHS’s Office of the Inspector General to examine the review process for Biogen’s Alzheimer’s disease treatment, Aduhelm.

Woodcock Seeks Outside Investigation to Restore FDA Credibility

The Center for Biologics Evaluation and Research’s top priority is to approve biologics license applications (BLAs) to address vaccine hesitancy, according to CBER director Peter Marks.

Full Approval of COVID Vaccines Key to Addressing Hesitancy

The latest draft supports the creation of the Biden administration’s proposed Advanced Research Projects Agency for Health to accelerate research on cures for cancer, diabetes, Alzheimer’s and more. 

New “Cures” Bill Aims to Advance R&D, Drug Development

CDER launches an initiative to gain more efficient and transparent operations of its advisory panels. Jill Wechsler reports.

FDA Advisory Committees Under Scrutiny

FDA’s approval of Biogen’s treatment for Alzheimer’s disease has raised questions about the agency’s accelerated approval process.

New Alzheimer’s Drug Heightens Debate Over FDA Accelerated Approval Process

The Biden administration has rolled out a broad initiative to promote domestic production of critical materials, including medicines and their ingredients.

White House Promotes US Drug Manufacturing to Secure Access to Vital Medicines

The Biden administration supports a notable increase in funding for public health and research as a lead priority for the coming year.

Biden Budget “Wish List” Maps FDA and Health Care Priorities

Biopharma companies’ efforts to promote “vaccine equity” and “dose sharing” also aim to limit challenges to international patent protections.

Vaccine Makers Ramp Up Production, Donations to Protect IP

FDA recently published a final guidance for making post-approval manufacturing changes to drugs and biologics, the culmination of a long-running effort to facilitate improvements in medical product quality through the product life cycle.