The White House Initiative on Women's Health Research: A Presidential Boost.

Women's Health Research, barely 40-year-old in the United States has recently received an all-important boost from First Lady Jill Biden. The $100 million in question are bound to make a meaningful difference in this all-important arena. It was the view of the White House that "our nation must fundamentally change how we approach and fund women's health research." The White House expressed its hope that "congressional leaders, the private sector, research institutions, and philanthropy" will answer the call to "improve the health and lives of women throughout the nation."

The Impact of Serialisation on Operational Efficiency and Productivity in Irish Pharmaceutical Sites.

Technology enabling drug serialisation technology was introduced by regulators to enhance security in pharmaceutical supply chain and protect drugs from infiltration by falsified and substandard medicines. The introduction of systems for serialisation required huge financial outlays manufacturers of pharmaceuticals. This study investigated the impact of serialisation on the operational efficiency and productivity in Irish pharmaceutical sites. A qualitative study was conducted with 11 manufacturing sites in Ireland. The participating companies operated a total of 114 pack-lines, representing approximately 65% of the automated packing lines in the country. The study found that serialisation had a negative effect on packaging production line OEE and line availability and on the individuals cost per unit of packaged pharmaceuticals. The research results estimated that the capital costs of serialisation were four times greater than those estimated by the regulators. There was a 4.1 cents average cost per pack for serialisation with high volume sites reporting an annual cost of serialisation of up to €4.5 m per annum and a 2.7% increase in the average cost of goods sold. A pattern whereby where many pharmaceutical manufacturers are transitioning from smaller batch production and moving toward larger batch production sizes in order to increases efficiencies was identified. The research also proposed the use of a serialisation depreciation factor as a method to determine the impact of serialisation on the cost of goods sold. This is the first study of its kind into the cost of serialisation from a manufacturer's viewpoint and studying the effects of serialisation on productivity, line availability and operational efficiency.

The Pregnant Workers Fairness Act-a Bipartisan Step Forward.

This Viewpoint describes key provisions of the Pregnant Workers Fairness Act and discuss the proposed Equal Employment Opportunity Commission rule, as well as its application to health care employment in particular.

Pharmacy Benefit Managers in the Eye of the Storm: Growing Multipartite Scrutiny.

The high cost of prescription drugs in the U.S. remains an ongoing national challenge. A recurring focal point in discussions over this distressing steady state is the role(s) played by Pharmacy Benefit Managers (PBMs) who negotiate drug prices with pharmaceutical manufacturers, conduct drug utilization reviews, engage in disease management, and see to formulary creation. At their inception, the multiple newly established PBMs were arguably intent on constraining the rise of prescription drug prices. At the time of this writing, however, the lion share of a far less competitive PBM market is controlled by CVS Caremark, Express Scripts, and OptumRx. It is this evolving reality which could be interpreted to mean that the PBMs may have become part of the problem, rather than part of the solution. Expanded scrutiny of the PBMs by Federal and State authorities as well as by Professional Medical Associations must not be delayed with an eye toward affording the public with relief from the high cost of prescription drugs.

Medicare Advantage: Growth Amidst Mounting Scrutiny.

The Medicare Advantage Program, home to nearly half of the eligible Medicare population, has recently come under increased scrutiny. The Government Accountability Office called on the Centers for Medicare & Medicaid Services to monitor "disenrollment of MA beneficiaries in the last year of life, validate MA-provided encounter data, and strengthen audits used to identify and recover improper payments to MA plans." The House Subcommittee on Oversight and Investigations of the Committee on Energy & Commerce, dedicated a hearing to "Protecting America's Seniors: Oversight of Private Sector Medicare Advantage Plans." In addition, a recently conducted audit of the Office of the Inspector General of the Department of Health and Human Services raised concerns over "denials of prior authorization requests" and "beneficiary access to medically necessary care." In this article we consider the backdrop for the growing scrutiny of the MA program and the implications thereof to its future trajectory.

Maternal Mortality Crisis and Extension of Medicaid Postpartum Coverage.

This Viewpoint discusses the maternal mortality crisis in the US, the need for an extension of Medicaid postpartum coverage, and the residual challenges across the US related to maternal health.

Should the Administration for Strategic Preparedness and Response Lead the National Response to a Public Health Emergency?

This Viewpoint examines the future role of the Administration for Strategic Preparedness and Response in light of the COVID-19 pandemic.