Pharmaceutical Technology, Pharmaceutical Technology, December 2023, Volume 47, Issue 12
Pages: 10
FDA and industry face unprecedented political and policy challenges.
In the 30 years that I have been writing about FDA policy and biopharmaceutical research and drug manufacturing, I have not encountered a time as troubling or uncertain as the present. The political battles over medications for abortion, vaccine safety, and shortages in vital medicines undermine long-held confidence and support for the nation’s regulatory system for food, drugs, and medical products. Add to that Congressional delays in reauthorizing national initiatives to prepare for future pandemics, incentives to develop much needed anti-infective medicines, and funding for the highly acclaimed PEPFAR (the US President’s Emergency Plan for AIDS Relief) program, which provides antiviral medicines to combat AIDS around the world.
End of an Era
In this December 2023 issue, Pharmaceutical Technology’s Washington reporter, Jill Wechsler, is ending her tenure as a contributing editor to the publication. In January of 1990, Jill’s column, titled “New Era for the Pharmaceutical Industry”, highlighted attacks on the US drug regulatory process that called for stricter regulations. Ironically, if you read Jill’s final column in this issue of PharmTech, it seems that as much as the industry has changed and evolved, some things remain the same.
Jill’s reporting on decades of regulatory and government topics has given her a unique perspective on the pharmaceutical industry that cannot be reproduced, and we here at PharmTech will greatly miss her. We thank Jill for her journalistic integrity, hours of coverage at conferences, countless blog posts, and numerous articles.
We wish her all the best for her future endeavors!
—Susan Haigney, managing editor
REGULATORY WATCH COLUMN
To read Jill’s extensive coverage of FDA and other regulatory news, Jill’s Regulatory Watch column can be accessed on our website at www.PharmTech.com/topic/regulatory-watch.
PHARMTECH TALK BLOG
Jill covered a variety of topics in her PharmTech Talk blog posts over the years. To read past PharmTech Talk posts, visit www.PharmTech.com/topic/pharmtech-talk.
Jill may be contacted at jillwechsler7@gmail.com.
Congressional infighting over federal spending furthermore threatens to limit funding and support for FDA as well as the National Institutes of Health (NIH) and vital national health programs. Such developments undermine the nation’s leadership in biomedical research and discovery of cutting-edge medical treatments. The situation could get worse, moreover, if the Supreme Court permits states to limit access to medical products approved as safe and effective by FDA, but with medical uses opposed by certain interest groups.
These and other contentious issues seem to ignore the remarkable success over the past three years of the public-private partnership that linked government funding to industry research to produce treatments able to arrest the spread of COVID-19. And even though FDA policies have long provided the “gold standard” around the world for conducting clinical research to assess the safety and efficacy of untried therapies, the political attacks on the United States regulatory process are exhausting its leaders and undermining agency morale.
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As Washington correspondent for Pharmaceutical Technology®, I have commented extensively on these and a wide range of political, legal, and regulatory developments that have shaped medical product R&D and production in the US and abroad. I became familiar with drug regulation soon after Congress enacted legislation creating the modern generic drug industry and as FDA revised clinical research and regulatory policies in response to the AIDS epidemic. And while it was clear in 2004 that a Medicare drug benefit would greatly expand access to medicines for elderly Americans, it also set the stage for increased government scrutiny of prescription drug prices, as demonstrated by recent events.
Similarly, the biotechnology revolution has opened the door to major advances in treatment of critical medical conditions, laying the groundwork for a whole new industry in the US and abroad. But the growing realization that many Americans struggle to afford those costly new medicines, as compared to citizens in other wealthy countries, has eroded public confidence in pharma and supported calls for patent and pricing reform. Manufacturers now are accepting Medicare price negotiations to avoid being shut out of program coverage, but participation may erode if such policies dry up private investment in the discovery of vital new therapies for patients, as industry predicts.
Although drug shortages will continue to draw more fire on the political front due to antiquated and often unreliable production processes, a main problem is that many of the products now in limited supply are low-cost generic drugs made by companies with limited resources to fund modern manufacturing operations. Innovation in this area may finally gain ground, though, as a way to expand availability of new gene and biotech therapies that are costly to produce and distribute.
The COVID-19 national emergency exposed the fragility of our public health system and public confusion about programs and policies needed for a thriving biomedical research enterprise equipped to further tackle cancer, dementia, and a host of debilitating conditions. I can only hope that policy makers will look for ways to encourage, and not derail, such efforts, and that the nation will support policies and programs that improve the health and well-being of society—and avoids imposing personal beliefs on others that can limit access to life-saving and life-enhancing treatments.
About the author
Jill Wechsler is Washington reporter for Pharmaceutical Technology®.
Article details
Pharmaceutical Technology Vol. 47, No. 12 December 2023 Page: 10
Citation
When referring to this article, please cite it as Wechsler, J. Signing Off from Washington. Pharmaceutical Technology 2023 47 (12).
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