Drug shortages have increasingly made headlines in recent weeks. While motivation and awareness are increasing, we are falling far short of taking actions that can alleviate the shortages, remedy the root causes, and assure near-zero comparable risk in the future.
The White House formed a task force earlier this year to review this situation, but no formal recommendations have emerged. The task force met again on July 28th, but there were no reports of actions or progress formally stemming from that session. At present, there are multiple emerging bills and approaches in discussion, but not convergence.
The most significant, recent action on this was a bicameral request for information (RFI) to inform policymaking that was led by House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Senate Finance Committee Ranking Member Mike Crapo (R-ID). The scope of this was intentionally broad, including a fundamental look at generic drug pricing and margins.
It is important to place this into a frame that emphasizes the lives at stake, first, above all other considerations. Drug supplies have become broadly more vulnerable to natural events, wars, and administrative processes. The recent news that a Pfizer facility that manufactured common acute, infused medicines was struck by a tornado is but another recent example of the vulnerability of our supply chain to events that may become more frequent. But the shortages of cancer medicines are different, more acute, and deeply troubling for patients and providers.
On July 27, 2023, the American Society of Clinical Oncology (ASCO), noted the creation of a Drug Shortages Advisory Group to suggest a range of new practices that can assure those patients that need drugs most have that access. The ASCO guidance emerging from this body is unprecedented, recommending re-prioritization of non-essential use of antineoplastic agents that may be in limited supply, encouraging use of alternative agendas. It further suggests opportunities for increasing the time interval between administration cycles, reducing treatment doses, omitting certain agents from regimens, establishing a range of waste reduction approaches, and creating institutional policy bodies to determine utilization and access. Finally, there are recommendations for providing counseling services, where available, for shortage-related patient stress experience by patients and clinicians.
Those dedicated to the field of oncology research and care are relentless in assuring that research moves forward as rapidly as possible and that all patients have access to care and clinical trials. More than 80% of breakthrough designations granted by the U.S. FDA are for oncology and hematology therapeutics. Academic centers, healthcare providers, regulatory agencies, and biopharma companies do this because of the incredible burden and suffering that cancer can cause to patients and their families. At stake are precious lives, families, and communities. To now have common therapeutics – mainstays of treatment – in short supply and adding to the worry, distress, and burden of a devastating disease is unthinkable. To further see those responsible for care feeling torment from an inability to deliver their best care is unbelievable.
We want to encourage a ‘motivated intolerance’ of this situation. There are strategies for enterprises called ‘business continuity,’ plans intended to ensure essential activities and services are sustained through a range of destructive to catastrophic events, that need to be deployed. Hospitals, telecom companies, financial services firms, pharmaceutical companies, and others prepare these as routine parts of their business planning and operational enablement. The factors driving the shortages are multiple. Many of the elements of these drugs are made abroad and the final finished drugs are also made and shipped from those locations. During the pandemic, several of the source countries restricted exports to assure their own country and patients had adequate supplies. Exacerbating these issues was a shutdown of a major, foreign manufacturing facility for quality problems.
Here, too, the situation has its own “unbelievable” elements. One the of the facilities implicated in this shortage is Intas Pharma. On August 1st, it was reported that an Intas employee destroyed records at the plant shut down after FDA identified quality issues. A reading of the report and letter to Intas outlines the scope of issues and their exceptionally troubling nature. On top of this, as a response to the legislative inquiries into drug shortages, the FDA indicated that much of their oversight and enforcement depended on voluntary information on production and quality issues. With 40%+ of the facilities being outside of the US, oversight and information access was slow and challenging.
We are intentionally not noting the specific countries so as to not make this about them – rather, it is about the failures and the remedies required now. In Europe, there are moves to remedy these same issues that have advanced faster than the US’ responses. These EU initiatives to assure their supply may have unwittingly complicated US access issues. The fact that we have inadequate supplies of life saving drugs that are decades old in 2023, post-pandemic, is unbelievable and inexcusable. The US maintains stockpiles of petroleum, monkeypox vaccine, antibiotics, etc. for catastrophic events, yet, we have not made specific provisions and requirements for cancer medicines. The European community also saw this situation as analogous to critical semiconductor components, and are requiring within the community manufacturing in assurance of supplies. These are our sickest citizenry and those we should be most committed to protect.
We would encourage immediate consideration of the following:
- In consultation with the ASCO, American Society of Hematology, and comparable organizations, the Executive Branch and HHS FDA should use its emergency powers to commission additional volumes of critical cancer and acute therapeutics to be produced. This should include rapid designation of manufacturing facilities within ‘highly trusted’ jurisdictions and locations not subject to constraints under a range of scenarios. At the outset, there should be specific quantities designated from each.
- HHS FDA should further require 70%+ of cancer drug production to be made in facilities in the continental US with geographic redundancy (e.g., mid-Atlantic, Midwest, West, etc.). This should be in place within 9 months.
- HHS FDA should commission a procurement surveillance initiative, such as was done with vaccines at the beginning of the pandemic, to import medicines from multiple geographies in assurance of supply for patients today. On an ongoing basis, HHS FDA should review all oncology and acute therapeutics for their status, supply, and as to whether they should be treated within the same assured supply program.
- The unattractiveness of the generics market for companies is now well documented and understood. This is penalizing US companies and forcing unattractive decisions as to whether they sustain their production and marketing of these medicines to the detriment of US patients. There should be immediate consultations with the Biotechnology Innovation Organization (BIO) and PhRMA about approaches that can meet industry, HHS, FDA, and of course, patient obligations.
- This can all be done under an Executive Order but, to assure it is seen by patients and physicians as a commitment, it should be endorsed and funded for five years in a standalone legislation in the coming 90 days by the Senate and House.