Last week Sen Hawley (R,MO) introduced S 3343, the Medical
Supply Chain Security Act. The bill would add medical devices to the
requirements for reporting discontinuance or interruption in the production of
life-saving drugs.
Amendments
Section 2(a) of the bill would amend 21
USC 356c, Discontinuance or interruption in
the production of life-saving drugs. Essentially every place the current §356c
says ‘drug’ the bill would change it to say ‘drug and device’. It would also
add a new paragraph (j), Additional manufacturer reporting for essential drugs
and devices. This would add an annual reporting requirement for the following
details about drugs and devices under §356c {new §356c(j)(1)}:
• All locations of production;
• The sourcing of all component
parts;
• The sourcing of any active pharmaceutical
ingredients; and
• The use of any scarce raw
materials.
Section 2(b) of the bill would amend 21
USC 356c-1, Annual reporting on drug
shortages. These changes would substitute the words ‘drug or device shortages’
for the word ‘drug shortages’.
Moving Forward
Hawley is not a member of the Senate Health, Education,
Labor, and Pensions Committee so it is unlikely that this bill will be
considered in Committee. I see nothing in this bill that would engender any
specific opposition. If this bill were considered in Committee, I expect that
it would receive bipartisan support.
Commentary
This bill, as I suspected, has nothing to do with cybersecurity
issues (more on that later) and I would not normally cover this bill in my blog
for that reason. But it does provide me another chance to talk about a chemical
safety issue.
Hawley’s reason for crafting this bill almost certainly has to
do with discussions about the expected shortage of a class of medical devices known
as respirators. This discussion is related to the expected problems associated
with the CODIV19 virus that is starting to affect this country. In the most serious
cases of respiratory disease that are a result of a relatively small percentage
of cases of the disease associated with CODIV19 patients require the breathing
assistance provided by mechanical respirators.
As I have noted in a number of blog posts about responding
to many large-scale chemical releases, there are a relatively limited number of
respirators available at each hospital. They are expensive pieces of equipment to
buy and maintain and are not needed that often in the normal course of events.
Each hospital has enough of these devices on-hand to meet their normal needs.
When there is a radical increase in the number of cases of respiratory injuries
or disease that require the use of respirators, hospitals end up having to make
triage decisions about which cases will have access to those respirators.
When the number of patients requiring the use of respirators
to survive exceeds the number of available respirators, patients are going to
have an increasing number of complications and many will die. If CODIV19
reaches epidemic proportions in the United States, it is very likely that we
will see a large-number patients die because of the lack of respirators.
The reporting requirements of this bill will have very
little impact on this situation. We will not need an increased number of
respirators until there are enough severe COVID19 cases to exceed the number of
available respirators. Reporting at that point will identify the problem after
it is too late to do something about the issue. Respirators take time to
produce and there is only a limited amount of production capability.
So, this bill will help in the finger pointing after the COVID19
outbreak is over. There is another way that his bill could be improved and that
is adding a medical device cybersecurity component to the reporting
requirements. That will not have anything to do with the current projected
problem with the COVID19 virus, but it could help the FDA track cybersecurity
issues.
The new §366c(j) could be modified by rewording (j)(1)(B) to
read:
(B) the sourcing of all
component parts, including software;
I will not be covering this bill any further.
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