U.S. Rep. Cathy McMorris Rodgers (R-WA), chair of the U.S. House Energy and Commerce Committee, is leading an investigation into the nation’s ongoing drug shortages and the Food and Drug Administration’s (FDA) response to the issue.
“In recent years, there have been shortages of critical medications such as antibiotics, flu therapeutics, saline, morphine, and cancer drugs,” wrote Rep. McMorris Rodgers in a March 27 letter sent to FDA Commissioner Dr. Robert Califf. “In fact, new drug shortages in the country saw a 30 percent increase from 2021 to 2022, posing a risk to public health and national security.”
Two Energy and Commerce Committee members, U.S. Reps. Brett Guthrie (R-KY) and Morgan Griffith (R-VA), joined Rep. McMorris Rodgers in signing the letter, which noted that the FDA Drug Shortage Database lists over 120 drugs that are currently in shortage, while a drug shortage list from the American Society of Health System Pharmacists includes more than 233 such entries.
“The FDA states that it monitors ongoing drug shortages and works closely with manufacturers and others in the supply chain to understand, mitigate and prevent or reduce any related impacts,” wrote the lawmakers. “The FDA has also requested additional legal authority from Congress to gain additional access to medical supply chain information. However, it is not clear to the committee that FDA is effectively using its existing authorities.”
For example, the committee members pointed to a section of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, which required companies to report annually on the amounts of each listed drug manufactured, prepared or processed for commercial distribution and information on where active pharmaceutical ingredients and finished dosage forms were made.
But the lawmakers wrote that it’s not clear to the committee what the FDA has done with the new data.
“To date, the FDA has not publicly released any summary of these reports in an aggregated way that may inform policy makers and provide the data Congress and others need as we examine ways to make sure the supply chain for drugs Americans need is secure,” they wrote.
Rep. McMorris Rodgers and her colleagues requested that Dr. Califf provide answers to numerous questions by April 13, including the total aggregated amount of each listed drug reported for each of calendar years 2020 through 2022, and to identify several details, including the country of origin engaged in the manufacturing and processing of the drug, and whether the drug is approved under section 505(a) or 505(j) of the Federal Food Drug and Cosmetic Act.
Among other questions, they also seek to know how information is being used to inform foreign inspection priorities and mitigate potential drug shortages, and requested information regarding the shortages of several drugs, including albuterol, amoxicillin, acetaminophen, and ibuprofen, according to their letter.