Key E&C Hearing Excerpts on Urgent Need to Address National Drug Shortage Crisis

Last month, the Energy and Commerce Committee's Health Subcommittee held a hearing on "Preparing for and Responding to Future Public Health Security Threats."

At the hearing, both Democratic and Republican Committee members asked Food and Drug Administration (FDA) Commissioner Robert M. Califf, M.D. about the ongoing national drug shortage crisis and the additional authorities requested by the agency to address the current shortages and prepare for future emergencies.

Committee Democrats continue to call on House Republican leaders to address the drug shortage crisis as Congress reauthorizes the Pandemic and All-Hazards Preparedness Act (PAHPA) this year. Democrats have put forward proposals in line with FDA's request for new authorities to improve our nation's ability to quickly identify and respond to supply chain shortages. Unfortunately, House Republican leaders continue to refuse to act on these policies to address the national drug shortage crisis as patients across the nation experience the devastating effects of the shortages.

Below are key exchanges from the transcript of last month's Health Subcommittee hearing between members and Commissioner Califf on the need to address the national drug shortage crisis:

FDA Commissioner Califf's opening remarks, "PAHPA recognizes the key role FDA plays in public health, emergency preparedness, and response. The FDA has effectively used the authority provided under PAHPA to support our nation's preparedness and response capabilities. However, there have been lessons learned about how these authorities could be modernized to ensure our actions can be even more effective.

"Providing greater transparency into supply chains, ensuring operational readiness and surge capacity within the FDA Inspectorate and its review staff, and improving laboratory testing regulation are priorities that will enhance national security and improve public health preparedness."

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Commissioner Califf continued, "Additionally, most drug shortages were historically due to manufacturing issues that disrupted supply for which manufacturers of drugs and active pharmaceutical ingredients are required to notify the FDA. The agency has relied on these notifications to help prevent supply disruptions -- approximately 220 over the last year -- by working closely with manufacturers, expediting review, and exercising temporary regulatory flexibility.

"However, we have recently seen an unprecedented demand for drugs that would benefit from similar notifications. The ability to require drug manufacturers and distributors to report surges in demand to FDA could help the agency prevent or mitigate shortages, including for some critical over-the-counter drugs like we saw this fall.

"Additional improvements should include reporting API sources and the extent of manufacturer reliance on certain suppliers in the drug supply chain, and ensuring FDA has an opportunity to inspect certain over-the-counter drug facilities before such products are distributed.

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Ranking Member Frank Pallone, Jr. (D-NJ), "The problem that our members have seen in just the last few months is the shortage of drugs that seem to be related to increases in demand. And currently, drug manufacturers are required to report to FDA when there is a discontinuance or interruption in the supply. However, when the shortage is driven by demand, rather than supply, manufacturers are not required to report to FDA.

"So can you explain how FDA can help address drug shortages when they have more information from drug manufacturers? Can FDA apply those tools if they know of an unanticipated spike in demand?

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Commissioner Califf, "All right, very quickly, every company keeps projections on what it needs to produce to meet the demand that it expects. When the demand goes up beyond what they can produce, they need to let us know, so that we can look across companies and see how we can make up for that problem. That is, essentially, the basic issue.

"Each company doesn't know what the other company is doing, because they are competing. When there is a shortage in one company we need to be able to coordinate across these people. Government should not be involved in private enterprise when things are working fine, but when there is a problem we have to have a mechanism for government to help out, as we have seen in many cases over the pandemic."

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Rep. Bob Latta (R-OH), "Dr. Califf, what steps should Congress take to further protect access to and further safety of pharmaceuticals while preventing supply chain shortages?

Commissioner Califf, "Well, as we have already discussed, better information for FDA to coordinate when there is an impending shortage, and basically using talk therapy with the industry to get cooperation and collaboration where it is needed -- because normally, they are competitors.

"But in the long run we have got to deal with the fact that many of these commodities and generic products are very low cost. There is a -- there is intense competition. And when the price gets below what can support -- you mentioned a highly-qualified workforce, investment in facilities -- then the pressure to offshore comes in, which we have also talked about. So we have got to deal with these adverse economics that are occurring.

"That is well beyond the FDA's remit, but it is a very important part of it. But we specify in our documents what -- in our requests what we need to fill in, those data parts where we can deal with it with the situation that we are currently in."

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Rep. Lisa Blunt Rochester (D-DE), "Dr. Califf, the FDA is requesting additional transparency authority to require manufacturers to tell you which suppliers provide them with the ingredients they use to manufacture their drugs. Can you describe the gaps FDA still has in its understanding of the drug supply chain, and how what you are requesting will benefit the American people?

Commissioner Califf, "Sure, thanks. This is a difficult problem that we are all struggling with, and very noticeable, as you point out.

"The primary gap we have is that what we need is the API, active pharmaceutical ingredient. Essentially, the raw material gets processed in one place, sent to another place, where the pill is made, and then sent through a distribution chain to where it eventually lands. We have in sight – line of sight into parts of that chain, but not all of it. And in particular, the API, which often is coming from India or China right now, we have very little insight into how that is working.

"How would we use the information if we had it? As long as things are fine, we have no interest in interfering with the private business of medical product distribution. But when there is a problem or an impending problem, we need to work across the manufacturers who otherwise don't share data -- it is confidential commercial information -- and we need to get them to coordinate to make up for if there is a deficit one place, to make up for it in another place. And there are four or five ways we do this that we can go into in detail.