Drug Shortages - Part III (Transparency & End-to-End Visibility)

Note: This article is the third entry of a series of mind maps listing actions that can be taken in various areas, that if/when taken and implemented collectively can contribute to systematically improving the situation.

Framework Needed:

I - Development/Implementation of New Capacity and Capabilities

II - FDA Quality Program

III - Transparency & End-to-End Visibility

IV  Ongoing Oversight and Reaction

V - Overall Coordination of Efforts

VI - Putting It All Together

Drug Shortages - Part II (Quality Program)

Note: This article is the second entry of a series of mind maps listing actions that can be taken in various areas, that if/when taken and implemented collectively can contribute to systematically improving the situation.

Framework Needed:

I - Development/Implementation of New Capacity and Capabilities

II - FDA Quality Program

III - Transparency & End-to-End Visibility

IV - Ongoing Oversight and Reaction

V - Overall Coordination of Efforts

VI - Putting It All Together

Update: Interesting development: Valisure and DoD Signed a Cooperative Research & Development Agreement to Conduct a Pharmaceutical Quality Risk Assessment Pilot Study https://www.prnewswire.com/news-releases/valisure-signs-agreement-with-department-of-defense-to-independently-test--quality-score-drugs-301895301.html

Drug Shortages - Part I (New Capacity and Capability)

Background: Drug shortages are back in the news. This time it is a shortage of some essential cancer-fighting drugs such as cisplatin and carboplatin, see: FDA allows temporary import of unapproved Chinese cancer drug to ease U.S. shortage. Although there are multiple factors that can occur to cause drug shortages (see the list of possible causes I put together in 2002 with contemporaneous examples, republished on my blog in 2011 and on LinkedIn in 2015.), in this case the issue was caused by an Indian manufacturer (Intas) halting production at one manufacturing site following the discovery of quality deficiencies during an FDA inspection. This then snowballed, threatening lives, and leading to the FDA's emergency approval of the import of 'unapproved' versions of the drugs from China. 

According to the New York Times - Drug Shortages Near an All-Time High, Leading to Rationing - "The shortages are so acute that they are commanding the attention of the White House and Congress, which are examining the underlying causes of the faltering generic drug market, which accounts for about 90 percent of domestic prescriptions. The Biden administration has assembled a team to find long-term solutions for shoring up the pharmaceutical supply chain..." Unfortunately, we have heard this many times before. For example in 2018, the FDA (once again) put together a drug shortages task force to produce solutions. I expressed skepticism at the time!

It's long been clear to me that there has been a market failure and that a root cause for many of our drug shortage problems is that the segment of our drugs ("old," long-available, off-patent and generic sterile injectable drugs) that are disproportionately responsible for drug shortages are priced too low. As such, the usual 'article of faith' that is so often served up as a supposed solution to the issue (example from the NYT, 2017) i.e. "Increasing the number of competitors for a given drug in the marketplace will also help prevent and mitigate future shortages" is nonsensical!

The below, from January 2018, is exactly why we just have had the availability issues for cisplatin and carboplatin!

Unfortunately, as I observed, a solution that requires higher prices is not very palatable. The fact is that many (most) people think of drug manufacturers as a monolith, instead of recognizing that there are distinct segments that operate under very divergent conditions. In February 2019 I asked the question: "Drug pricing- is there a topic more fraught with simplism in this day and age?" Unfortunately, the answer was and continues to be "no!"

The bottom line? We will need to eschew simplistic thinking if we are to make any lasting progress in this area. Additionally, looking to the FDA to come up with a solution is flat out wrong. The solution to decreasing the frequency of drug shortages and mitigating their effects is multifactorial and will require a 'Whole of Government' approach that also includes collaboration and partnerships with industry, scientific organizations, public-private partnerships, academic organizations, and non-profits.

Note: This article is the first entry of a series of mind maps listing actions that can be taken in various areas, that if/when taken and implemented collectively can contribute to systematically improving the situation. First up, we need to improve pharmaceutical manufacturing capacity and capability!

Framework Needed:

I - New Capacity & Capability - the development and implementation of needed new capacity (e.g. plant, inventory) and new capabilities (e.g. advanced manufacturing technology) for drug manufacturing:

II - FDA Quality Program

III - Transparency & End-to-End Visibility

IV - Ongoing Oversight and Reaction

V - Overall Coordination of Efforts

VI - Putting It All Together