Achieving health equity – the opportunity for all patients to live a healthy life, irrespective of their circumstances – requires the collective effort of the entire medical product development ecosystem. An example of such a collaboration took place at the September 2022 RAPS Convergence in Phoenix, Arizona, with joint presentations by representatives from the US Food and Drug Administration (FDA), Health Canada, and industry (Pfizer) who discussed enhancing diversity in ...

In 2021, Pfizer global regulatory affairs colleagues piloted an advanced pharmacy practice experience program as part of a company-wide diversity, inclusion, and equity program in collaboration with Howard University College of Pharmacy (CoP), a US-based historically Black college/university (HBCU). 1 Following pilot success, the initiative was elevated to full program status and the prospective student pool was expanded to include all HBCU CoPs in the US, as well as one ...

The Pfizer Global Regulatory Affairs (GRA) – Howard University College of Pharmacy (HUCOP) Advanced Pharmacy Practice Experience (APPE) program fulfills a requirement of the Doctor of Pharmacy (PharmD) curriculum and helps students explore biopharmaceutical industry career options and prepare for their career after graduation, such as pursuing postgraduate training and seeking employment. The HUCOP Preceptorship Program at Pfizer was designed to broadly increase awareness ...

Abstract The recruitment, hiring, and training of regulatory professionals should evolve to attract and retain valuable candidates with diverse perspectives, experiences, and/or skills. Regulatory professionals may consider doing this as part of their diversity, equity, and inclusion (DEI) initiatives by hiring “hidden workers,” a term for multiple groups of people who are chronically unemployed or underemployed because of systemic problems with current workforce trainin...

Pediatric oncology patients continue to have significant unmet medical need. Although the Pediatric Research Equity Act (PREA) mandated evaluation of new drugs for pediatric patients, the rarity and uniquity of pediatric cancers allowed for waivers or exemptions from PREA requirements. The passing of FDA Reauthorization Act amendments in 2017 included the Research Acceleration for Cure and Equity Act, which expands the scope of oncology products subject to PREA. Sponsors d...

A newly minted collaborative of industry, government, and patient groups is seeking to develop a set of best practices that will help make digital health measurement technologies work for all users, regardless of gender, race, ethnicity, and other factors.   The Digital Health Measurement Collaborative Community ( DATAcc ), launched in May 2021, is hosted by the nonprofit Digital Medicine Society (DiMe) and brings together more than 30 organizations, including the US F...

Orphan drug provisions in the House-passed 21st Century Cures Act could increase US healthcare spending by billions of dollars over the next decade, consumer advocacy group Public Citizen warns, though the bill still remains in limbo in the Senate. The provisions in question would add an additional six months of marketing exclusivity for approved drugs that later go on to be approved to treat rare diseases. The extended period of exclusivity would apply to all indicati...

The US Department of Health and Human Services (HHS) has unveiled new regulations to establish a parallel system of organ donation intended to serve patients with the human immunodeficiency virus (HIV). Background The regulations come almost a year and a half after US President Barack Obama signed into law the HIV Organ Policy Equity (HOPE) Act of 2013 . The law, passed in November 2013, modified the National Organ Transplant Act (NOTA) of 1984 by permitting HIV-p...