S 3343 Introduced – Medical Supply Chain Security

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.