Washington, D.C. - House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) sent a letter today to Food and Drug Administration (FDA) Commissioner Robert Califf requesting information related to drug shortages.
KEY EXCERPT:
“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.7 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, section 3112(e) of the Coronarvirus Aid, Relief, and Economic Security Act […] required, for the first time, companies to report on an annual basis 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. It is not clear to this 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."
The Chairs have request answers by April 13, 2023, to their questions, including the following:
1 The total aggregated amount of each listed drug reported for each of calendar years 2020 through 2022 and identify:
* the country of origin engaged in the manufacturing and processing of the drug;
* whether the drug is approved under section 505(a) or 505(j) of the Federal Food Drug and Cosmetic Act;
* whether the drug is listed under the FDA Drug Shortages online database as required under section 506E of the Federal Food, Drug, and Cosmetic Act; and
* whether the drug is listed on the Food and Drug Administration’s list of Essential Medicines, Medical Countermeasures, and Critical Inputs list as described in section 3(c) of the Executive Order 13944.
2 How information received under Section 510(j)(3) is being used to inform foreign inspection priorities and mitigate potential drug shortages.
3 The number of registrants required to comply with section 510(j)(3) of the Federal Food Drug and Cosmetic Act who have failed to report information on the amount of a drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, if any.
The Chairs also requested information regarding the shortages of:
* Albuterol (asthma)
* Pluvicto (cancer)
* Cisplatin (cancer)
* Fluorouracil (cancer)
* Methotrexate (cancer)
* Dacillus Calmette-Guerin (BCG) (tuberculosis)
* Amoxicillin (bacterial infection)
* Acetaminophen (headache, pain, fever)
* IIbuprofen (headache, pain, fever)