Drug Supply Shortages

Janson Silvers  0:03  
Welcome to health care policy pop. I'm Janssen Silver's it's Thursday, September 21 2023. Today's pop topics drug supply shortages continue to plague the health care system as the country prepares for an aggressive respiratory illness season. Gavin Clingham is the public policy director at the Alliance for patient access, and says this is an issue that has gradually been getting worse. 

Gavin Clingham  0:26  
Certainly, we're having a large problem right now with drug supply chain and drug shortages. As you know, the FDA determines when a drug is in a shortage state. And so we're at the highest level that we've been in decades. However, this has been an ongoing problem, and it doesn't seem to be getting better on its own. 

Janson Silvers  0:42  
While shortages persist across the board, some areas are harder hit than others. 

Gavin Clingham  0:47  
We're seeing particular challenges in generic medications. Generics are most vulnerable to shortages because they have such high demand due to their affordability. But they're relatively cheap or inexpensive. So the profit margins are incredibly low and are decreasing over time, the market dynamics at the root of the shortages are increasingly unsustainable, and so we're going to continue to see more 

Janson Silvers  1:07  
certain diseases are also more affected by the shortage. 

Gavin Clingham  1:11  
oncology patients cancer patients are seeing a large impact right now with with a severe shortage of chemotherapy drugs, but we're seeing the more common medications such as Adderall, antibiotics, saline and lidocaine. So things that are used in everyday medical practice and patient care are also being impacted by these shortages. 

Janson Silvers  1:29  
The causes are multifaceted, but why we've been experiencing these shortages for so long and what is being done. 

Gavin Clingham  1:36  
There are very few solutions that have been implemented at the federal level to date that have helped with this. Fortunately, the administration and Congress seem laser focused on this issue. Recently, the House Energy and Commerce Committee introduced draft legislation and held a committee hearing on drug shortages. The Senate is equally focused on this. And so the hope is to take a comprehensive approach to trying to solve and address these challenges. 

Janson Silvers  2:00  
Specifically, clean them says there are a few options, 

Gavin Clingham  2:03  
the FDA can take a number of steps. So regulatory harmonization with other countries and other regulatory schemes would be one thing that would help alleviating some of the reporting requirements that don't have a clear impact on quality might help the industry some, but really, we need a holistic approach to try and resolve this and really a deep look at the market dynamics that can help make this profitable enough, yet we'll have better competition. 

Janson Silvers  2:27  
You can find more information on Klingons organization by using the link in the show notes.

Janson Silvers  2:37  
On Wednesday afternoon, patients rising now submitted questions to the ANC oversight and investigation subcommittee that looked at how the IRAs price setting is affecting medicine options for patients. We'll have more on this hearing and the impacts of the IRA on drug development next week. Finally, today, CMS will host listening sessions for the first 10 drugs named for price setting. However, CMS said patient input will be limited to the 20 people who will be selected to speak during each session. Patient Rising now says that's not enough. And CMS must not limit public input. That's all for today. We're back on Tuesday for another health care policy pop a resource of patient rising now. I'm Janssen Silver's, have a great day.