House Oversight Panel Probes Drug Shortages

House Committee on Oversight and Accountability chairman James Comer (R-KY) and Subcommittee on Health Care and Financial Services chairwoman Lisa McClain (R-MI) are calling on FDA to provide extensive information on its response to a growing number of what they say are critical drug shortages delaying and prohibiting patients from receiving lifesaving medical treatment. In an 11/2 letter to commissioner Robert Califf, the lawmakers request documents and a staff-level briefing on the issue. 

“At the time of this letter, the FDA lists 128 drugs currently in shortage on its drug shortage database,” the letter says. “Current shortages include important drugs commonly used to treat infections, respiratory illnesses, heart failure, psychiatric conditions, and cancer, and include drugs such as amoxicillin, penicillin, albuterol, Adderall, and cisplatin/carboplatin. Earlier this year, there was a shortage of children’s acetaminophen and ibuprofen. The cancer drug shortage has gotten so severe that the FDA temporary (sic) authorized the importation of drugs produced by non-FDA approved Chinese manufacturers. The FDA is failing to ensure vitally important pharmaceuticals remain on pharmacy shelves.” 

The lawmakers note that the shortages pre-date the Covid-19 pandemic and have been “worsened by factors including an overreliance on manufacturing facilities located in foreign countries. Government price controls in Democrats’ Inflation Reduction (IRA) will further aggravate drug shortages by exacerbating supply chain insecurity and leading to less investment in new cures in the long-term.”

The letter requests that the agency provide the following information:

1. All documents and communications related to FDA’s work plan for investing in pharmaceutical data and supply chain analytics;
2. All documents and communications related to the agency’s work plan for incentivizing domestic pharmaceutical manufacturing;
3. All documents or communications related to medication shortages during the Covid emergency;
4. All documents on the agency’s plans for addressing compliance with Coronavirus Aid, Relief, and Economic Security Act requirements for mitigating drug shortages;
5. All documents and communications between FDA employees and White House staff regarding drug shortages; and
6. All documents and communications between FDA employees and HHS employees regarding drug shortages.