Hi, I'm Dr. Sarah Hohen. I am a pediatric intensivist. I'm also a palliative care physician and a pediatric bioethicist. I will be talking today about legislation around medication shortages, specifically, is there a light at the end of the tunnel? I don't have a conflict of interest or any financial disclosures. I did serve on the FDA Pediatric Advisory Committee from 2016 to 2022. This is the third session of three. The first two speakers were Colin Lee talking about why do we have medication shortages, supporting the supply chain. And the second one was mitigation for medication shortages by Gretchen Sasha. I just wanted to mention those because if it doesn't seem like this is the whole picture, it's because this is the third of three talks focused exclusively on legislation. What I'm going to do today is review the overall history of the FDA and regulation in our country. I will describe the number one shortage just because it's a good example of how different policies can be leveraged. I will talk about some common medication shortages, describe some post-pandemic legislation, and then try and frame our way forward towards a lens of advocacy. This is just a picture that goes through some examples of how the government has been able to leverage some of their resources. This was from February of 2022 in Wisconsin. This was specifically some National Guard members learning how to be nurse assistants so they could be used during the staff shortages related to Omicron. When we think about the history of regulation, the first thing that we think of actually goes back to 1202 where King John of England proclaimed the first English food law, the cease of bread, and he prohibited people from adding ground peas or beans to their bread and that's the first recorded case of regulation. Then in the United States around 1820, they first met and established U.S. Pharmacopoeia, which was followed about 25 years later by the Drug Importation Act. Then 20 years after that in the 1860s, President Abraham Lincoln appointed some chemists and then chief chemists within the Department of Agriculture to have passage of national food and drug laws. So then we know the FDA as we know it really came into its own in 1906 when they passed about 200 laws related to regulation. The first big specific medication act was the Shirley Amendment in 1912 and this was specifically to change the labeling of something they were selling for teething babies, Mrs. Winslow's Soothing Syrup for teething babies. It was actually laced with morphine, which is absolutely not something you should give your newborn baby. And so this was the first big regulatory change to remove morphine from the cough syrups for babies. Why this matters. So about 20 years after that in 1937, there was sulfolinamide, which killed 107 people, including many children. So this really highlighted why we need drug safety to protect our children. So we'll remember that was in 1937, yet there was a really long drought from 1937 until 2002. 2002 is when they passed the Best Pharmaceuticals for Children Act, which really improves the safety and efficacy of both patented and off patented medications under the FDA. This was a revision of the Modernization Act of 1997 and it incentivizes the pharmaceutical companies to ensure that they're studying the impact of their medication on children. And if they were to submit data about how their medications impacted children, they got another six months of exclusivity of their patent. So then we leap towards the next sort of crisis, which here was September 11th in 2001. In response to that, they did the Public Health Safety and Bioterrorism Preparedness and Response Act of 2002, which was really specifically to develop and coordinate a coordinated strategy around bioterrorism and other public health emergencies. So then we fast forward to 2013, the DQSA, which is the Drug Supply Chain Security Act, which really tried to crack down on different people selling generic medications and focused on national licensure standards to make sure that everybody who said they were selling a certain medication was actually selling that medication. So when we think about medication shortages, there's a lot of discussion about whether or not we can mitigate this by expired medications. And before we get into it too much, I just wanted you to take a minute and think about have you ever taken expired Motrin, seen a bottle of expired Tylenol, taken medications for a different indication, taken leftover antibiotics? I suspect if we were in person doing a Zoom poll that 60 to 70% of people would have at some point in their lives knowingly intentionally taking expired medication, which might not be such a bad thing. We first focused on the expiration dates not being as relevant when there was the EpiPen shortage. And one of the first things they did with the EpiPen shortage is evaluate whether or not the expiration dates on the EpiPens were really necessary. The second thing that they looked at in terms of other medications for drug stability are some of the liquid medications. And what they found is that many medications are potent years past their expiration dates. The US Air Force did a study because they had billions of dollars of medication that were close to or past their expiration dates. And they found that they were still very, very reliable and were equally active biochemically and pharmacokinetically and equally potent three years after their expiration date. The exception to this was liquid capsules. The liquid capsules might not be as reliable three years after their date, but certainly this is important information for us to think about. So then we fast forward to a more recent time. So what we do know is that more recent legislation really looks at drug marketing applications and how we can prepare for a shortage. So this MEDS Act was introduced October 19, 2019. It was introduced by Senator Collins from Maine. I will highlight a few of the people who have been most active in the public health legislation domain in the last five years, not to promote one political agenda or the other, but just to let you know whose name you should look out for and different people who are very active in this area. So what did this act that she proposed do? What they said was that we need an action plan to mitigate drug shortages and then provide incentives for the manufacturing to make sure that we really know what are the active pharmaceutical ingredients and make sure that we have incentives in place for companies to make enough PPE. This is expanded to the Drug Shortages Shelf Life Extension Act. And specifically, this updates FDA guidance regarding stability testing tied to shelf life expiration dates. And this requires the FDA to report to a higher level, which is to the U.S. Committee on Health, Education, Labor, and Pensions and to the House Energy Committee and look very specifically at labeling changes and product expiration dates. So this is what the bill looks like. I thought it was useful to see the actual appearance of how the bills look in Congress. So this is S.2723, which is to otherwise known as Mitigating Emergency Drug Shortages Act. This is the same bill that Senator Collins introduced October 19, 2019, and it's one of the most expansive and specific bills that we have to address the emergency drug shortages. So what did Senator Cardin say about this? He said, the U.S. is the wealthiest nation in the world. No one in the country should fall victim to prescription drug shortages. The federal government must work to ensure that patients who rely on life-sustaining medications for the treatment of basic infections, cancer, autoimmune diseases, and basic medical procedures like saline and epinephrine will always have an adequate supply of prescription medication. No one should have to go without essential prescription drugs when usable supplies are available despite the date stamped on their expiration date. So you can see people are really getting around changing the expiration date as the biggest area of focus for legislation on medication shortages. So then the pandemic happened. So in March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security Act, which is called the CARES Act. And this looked very specifically at how we could minimize disruption of specific medications that are needed for the public health medication. So how can we ensure that we're not going to run out of remdesivir? How can we make sure that we're not going to be misguided by false expiration dates to make sure we have adequate access to medications? I mentioned earlier that I'm going to highlight some of the people who have been the most active in this process. Again, only so we know who to keep our eyes on and who to listen for the next few years. So on the left, it's Representative Earl Bud Carty, who's a Republican from Georgia. And on the right, you have Senator Cardin, who is the quote I read to you a few minutes ago. He is a senator who represents the state of Maryland. But you can see that when there's bipartisan support, everyone can agree on how important it is to not run out of a supply of medication. So this, again, goes through a more recent one. This was introduced by Representative Carter. And what I liked about this is it shows you the process. So first, a bill has to be introduced, and then it has to pass the House, and then it has to pass the Senate. Then once it passes the Senate, it goes to the President, and then it becomes law. So when I, as I was preparing for this talk, and I think about what do we have in the realm of legislation, what we have in the realm of pending legislation is very different than what we have in actual law. And I think it's important that we differentiate between those two. So what do we know? Overall, we know that the FDA has a long history of regulation for safety. But we know that we need to balance this with addressing shortages. So it is very important, obviously, that things are not mislabeled and people are not getting inappropriate medication, such as morphine and cough syrup. But it's also important that we make sure that we're not wasting things. And with everything going on in terms of the world, the global pandemic, and now global security concerns, there's going to be more disruption of the supply chain. And it's going to be really important that we don't waste what we have, and that we make sure that we take advantage of what resources we have. And our biggest resource, honestly, may be this unexpired medication. So what are the future directions? So as I've been talking about, I really think the biggest piece of this from a regulatory or legislative standpoint is really going to hinge upon extending the expiration dates and minimizing waste. So it could be that they do some studies similarly to the ones that were done in the military, and they say, okay, if your bottle of ibuprofen says it's good, you know, that it's going to expire in 2000, it's actually good till 2002. And we might be able to look at commonly used medications such as epinephrine, such as acetaminophen, and then see if by just adding some years to that, we can ensure that we have ready access to appropriate medications. So it's really important that you get to know your representatives. I was fortunate enough to be involved in the AAP, which is the American Academy of Pediatrics Advocacy Committee. And through that, we had the opportunity to meet with our representatives, meet with representative from Senator Durbin's office, because I'm in Illinois, and it was interesting. We were talking about very boring topics, childhood immunizations, but after just one days of meetings with the staff from his office, suddenly we had representative Bobby Rush and Senator Durbin tweeting about how important it is that children circle back with their pediatricians and get caught up on all their missed immunizations. I only use that because for me, it was a really eye-opening experience of the power of one conversation at one point in time. And so I think it's really important that each and every one of us really embrace the concept of being an advocate, whether we email our congressperson, if we tweet them, if we call them. It is really, truly amazing to me how these small acts can make a really big difference. And I think we need to continue to make sure that we're advocating for appropriate policies, that we're optimizing the medications that we have, the stockpile, and that we're not wasting what we have. The other reason it's really important is that one of the things we saw during the civil unrest of the last couple of years is that in certain neighborhoods, when there is civil unrest, there's tremendous disruption to the pharmacies. If the pharmacies are looted and it takes them six months to open up again, it's going to be really hard for people to have adequate access to Tylenol and Motrin and these really basic medications. And so one of the reasons each and every one of us needs to become an advocate is to ensure that it's not just the people in the higher socioeconomic statuses that have reliable access to medication, but those living in urban environments, those with a lot of housing insecurity and food insecurity. How are we sure that they also have ready access to acetaminophen and ibuprofen? These are pretty basic things. So the reason I encourage each and every one of us to be an advocate for change is to make sure that we're being mindful of diversity, equity, and inclusion, because those who have more resources will always have better access to medication. I want to thank you very much for this opportunity to present. This was certainly a little bit of a challenging topic for me, but I learned a lot along the way, and I thank you for your time. I look forward to our open session, and please reach out to me directly if you have any questions.

Dr. Sarah Hohen

pediatric intensivist

medication shortages

FDA regulations

drug safety