Photo Credit: Tinatin1

Congress Launches Probe into Certain Drug Shortages; Seeking Company Input

Certain members of the House Committee on Oversight and Accountability have initiated an investigation into three long-standing, separate drug shortages, respectively seeking input from Teva, Sandoz, and Pfizer on their responses to their shortages and related manufacturing issues.
Photo Credit: Tinatin1

Certain members of the House Committee on Oversight and Accountability have initiated an investigation into three long-standing separate drug shortages, seeking input from Teva, Sandoz, and Pfizer on their responses to the shortages and related manufacturing issues.

Drug shortages under focus
This week (February 21, 2024), Rep. Jamie Raskin (D-MD), Ranking Member of the Committee on Oversight and Accountability of the US House of Representatives, along with other Democratic members of the Committee, sent letters to Teva, Pfizer, and Sandoz requesting a briefing and information for ongoing shortages of certain drugs, including the anti-cancer drugs, carboplatin, cisplatin, and methotrexate, the antibiotic, amoxicillin, and Adderall (mixed amphetamine salts), a drug to treat attention-deficit hyperactivity disorder (ADHD). The Committee is requesting the drug manufacturers provide information related to the shortages no later than March 6, 2024, to help determine root causes and practical solutions needed to remedy the shortages.  

Pfizer and its subsidiaries (Hospira) are manufacturers of carboplatin, cisplatin, and methotrexate, three generic drugs commonly used to treat cancer. Sandoz is a manufacturer of powder amoxicillin, which has been in short supply since October 2022. In September 2023, Sandoz issued a public statement attributing the antibiotic’s shortage to the marketplace and stating that the low price point for amoxicillin was causing manufacturers to exit the market, further exacerbating the shortage. Teva Pharmaceuticals is a manufacturer of Adderall. The US Food and Drug Administration formally announced a shortage of Adderall and its generic equivalents in October 2022, and since then, the Committee members said supply has not been sufficient to meet US market demand.

Other Congressional action on drug shortages
The move by the House Committee on Oversight and Accountability to gain further information on drug shortages is the latest action taken by Congress as it continues to examine the root causes of drug shortages and evaluate policy moves to mitigate them. Earlier this month (February 2024), the Ways and Means Committee of the US House of Representatives held a hearing that focused on chronic drug shortages. Testifying at the hearing were public health experts as well as representatives from the industry: McKesson, a drug wholesaler, and Civica, a non-profit generic drug company created by US health systems and philanthropies to address drug shortages.

Jeromie Ballreich, Ph.D., M.H.S. Associate Research Professor, Johns Hopkins University, who testified at the hearing recommended that Congress consider four policy solution sets to address chronic drug shortages: (1) improving transparency of drug supply chains; (2) addressing generic market resilience through demand-oriented policies by encouraging long-term market commitment of generic manufacturers and incentivizing investment for supply-chain resilience through the use of financial incentives directed toward the generics market; (3) increasing supply-chain resilience through supply-oriented policies, including financial incentives for US drug and active ingredient manufacturing; and (4) ensuring continued patient access via the establishment of a supply safety net by establishing supply buffers or stockpiles to mitigate the impact of any sudden changes to the drug supply chain.

Last December (December 2023), the Senate Finance Committee held a hearing that focused on strategies to strengthen the supply chain for generic sterile injectable drugs, as well as related actions to incentivize hospitals and other providers in purchasing these drugs.

Last July (July 2023), the Chair of the Energy and Commerce Committee of the US House of Representatives, Cathy McMorris Rodgers (R-WA), released a discussion draft with policy proposals to address drug shortages in the US. Among the proposals under discussion was to give manufacturers of generic, sterile injectable drugs for serious diseases, such as cancer treatments, more flexibility to respond to market pressures, so they can invest in manufacturing and ramp up production when potential shortage situations arise. The discussion draft also included a proposal to increase disclosure requirements on group purchasing organizations that control bulk contracts between drug manufacturers and healthcare providers. It also called on the US Food and Drug Administration (FDA) to exercise the reporting requirement authorities it already possesses, including reporting on certain active pharmaceutical ingredient (API) metrics for generics, and called for establishing a pilot program for FDA to conduct preapproval inspections for new US domestic sterile manufacturing facilities.

Other action by the US government on drug shortages
Congress is not alone in seeking information to address drug shortages in the US. Earlier this month (February 2024), the US Federal Trade Commission (FTC) and the US Department of Health and Human Services (HHS) jointly issued a Request for Information to understand how the practices of two entities—group purchasing organizations (GPOs) and drug wholesalers—may be contributing to generic drug shortages to better understand the root causes and potential solutions to drug shortages. The FTC and HHS are seeking public comment regarding market concentration among large healthcare GPOs and drug wholesalers, as well as information detailing their contracting practices. The joint RFI seeks to understand how both GPOs and drug wholesalers impact the overall generic pharmaceutical market, including how both entities may influence the pricing and availability of pharmaceutical drugs.

GPOs serve as intermediaries in the pharmaceutical industry by negotiating deals for generic drugs and other medical supplies between healthcare providers—including hospitals, physicians, nursing homes, and home health agencies—and manufacturers, distributors, and others who sell to healthcare providers. Drug wholesalers are another type of intermediary group that purchase drugs directly from manufacturers and deliver them to healthcare providers.

Drug shortages and the FDA
The US Food and Drug Administration (FDA) plays a major role in identifying and seeking ways to mitigate actual and potential drug shortages. It provides an annual report to Congress to summarize the major actions it has taken in a given calendar year to prevent or mitigate drug shortages in the US. The last such report, issued in June 2023, provided an analysis of drug shortages for calendar year (CY) 2022. During CY 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and FDA’s Center for Drug Evaluation and Research (CDER) worked with manufacturers to successfully prevent 222 drug shortages through the use of a range of available tools, including regulatory flexibility and discretion when appropriate.  During this same period, the number of new shortages tracked by CBER and CDER was 49, compared to a peak of 251 new shortages during CY 2011.

Requirements related to early notification of interruptions and discontinuances in manufacturing and FDA’s own actions are helping to reduce the impact of drug shortages, said FDA in its report. Although the number of new drug shortages has declined since 2011 as a result of work by many groups, including FDA, in its report, the FDA acknowledged that shortages continue to pose a challenge for certain drugs. For CY 2022, FDA was notified of 1,293 potential drug and biological product shortage situations by 150 different manufacturers. FDA said in its report that it continues to see a greater adherence to notification requirements, with an increasing number of manufacturers notifying FDA annually about potential shortage issues.

In its June 2023 report, FDA outlined the steps it is taking to mitigate drug shortages. Mitigation efforts begin once FDA confirms that a shortage exists or may occur. The actions FDA can take to prevent or mitigate a shortage include, as appropriate, the following:

• Identifying the extent of the shortfall and determine if other manufacturers are willing and able to increase production to make up the gap;

• Expediting FDA’s inspections and reviews of submissions submitted by affected manufacturers attempting to restore production;

• Expediting FDA’s inspections and reviews of submissions from competing entities who are interested in starting new production or increasing existing production of products in shortage;

• Expediting the release of lots of certain licensed biological products regulated by CBER or CDER;

• Reviewing requests for extensions of expiration dating;

• Exercising temporary regulatory flexibility for new sources of medically necessary drugs;

• Working with the affected manufacturers to ensure adequate investigations into the root cause of the shortage;

• Working with the Assistant Secretary for Preparedness and Response under the US Department of Health and Human Services on efforts under the Defense Production Act for the development of COVID-19 vaccines and therapeutics and supply-chain activities;

• Developing risk-mitigation measures to allow individual batches of a drug product to be released even when quality assurance requirements were not met; and

• Establishing communication channels with stakeholders and other interested parties.

Depending on the severity of the potential shortage and the surrounding circumstances, FDA can use one or more of these mitigation tools or seek to develop other options within its legal authority. When selecting specific tools, FDA said in its report it continues to work with manufacturers to tailor their responses to the specific situations. As a part of these actions, FDA also frequently communicates available information about a potential shortage or existing shortage to affected stakeholders and monitors the shortage until it has been resolved.

In its report, FDA identified two key priorities in its efforts to address drug shortages: the need to gain better insight into the drug supply chain and the need to increase the resilience of the supply chain. An obvious connection is that problems in the drug supply chain can create or worsen drug shortages. The Coronavirus Aid, Relief, and Economic Security (CARES) Act, signed into law in 2020,  includes authorities and requirements meant to enhance FDA’s ability to identify, prevent, and mitigate possible drug shortages by improving the agency’s visibility into the drug supply chain, but FDA says more is needed. While such provisions do include a requirement for manufacturers to notify FDA of API manufacturing discontinuances or interruptions and for drug manufacturers to report annually the amount of drugs they manufacture, manufacturers are not required to notify FDA of increases in demand that they are unlikely to be able to meet without meaningful shortfall or delay.

In addition, FDA pointed to the need to improve supply-chain resiliency. FDA said in its report that redundancy in the supply chain (as opposed to reliance on a single facility or geographic region) increases supply agility and potential solutions to alleviate shortages that occur due to regional or localized supply disruptions and that could ultimately create or exacerbate a drug shortage. The agency pointed to the importance of a provision under the CARES Act that requires certain manufacturers to develop a redundancy risk-management plan that identifies and evaluates the risks to the drug supply at establishments manufacturing a drug or its API.

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