Congress Launches Investigation into FDA Drug Shortage Response

On Nov. 2, the House Committee on Oversight and Accountability sent a formal letter to the FDA, requesting documents and insights on how the agency is navigating complex supply chains and reductions in domestic manufacturing as a result of drug price controls included in the Inflation Reduction Act (IRA). With 128 drugs currently facing a shortage, the committee is also requesting a staff-level briefing on how to better understand the FDA’s response and mitigation strategies to improve and sustain the supply of high quality, life-supporting medications available to Americans.¹

In August, FDA Commissioner Robert Califf, MD, weighed in on the situation, explaining that he was “fired up” about it and has labeled it as a national security threat.²

“I did not come back to FDA to spend all my time on supply chain, but that’s what’s happened,” Califf stated in response to a question about shortages during a presentation of the Alliance for a Stronger FDA. “And I feel like I know a lot about it, and I’m pretty fired up to do something about it.”²

The letter also states that supply chain issues have been going on long before the start of the COVID-19 pandemic. Apart from pandemic supply chain delays, the committee cites over-reliance on offshore manufacturing facilities, surging demand for pharmaceuticals, and diminishing manufacturing of generics. They suggest that one way to mitigate these problems would be to increase domestic manufacturing capabilities. Despite this, most pharmaceutical manufacturing has moved offshore to maximize profits.¹

In an attempt to ease the shortages, the FDA temporarily authorized imports of cancer drugs produced by non-FDA approved Chinese manufacturers earlier this year.³ The letter argues that this could be dangerous for US citizens. They also mentioned that illegal pharmacies will capitalize on these shortages in a potentially deadly way.¹

“Furthermore, illegal pharmacies take advantage of prescription drug shortages by marketing illegal or counterfeit versions of out-of-stock medications such as amoxicillin or Adderall on the internet. Desperation may drive consumers to purchase illegal or counterfeit drugs distributed without the supervision of a licensed pharmacist. The Drug Enforcement Administration (DEA) warns that counterfeit pills are marketed and made to look like legitimate prescriptions and often contain deadly amounts of fentanyl,” the letter stated.

In October of 2019, the FDA published Drug Shortages: Root Causes and Potential Solutions in an attempt to examine the underlying factors responsible for drug shortages and recommends enduring solutions. The study suggested the following reasons for the shortages:⁴

• Lack of incentives for manufacturers to produce less profitable drugs;
• The market does not recognize and reward manufacturers for “mature quality systems” that focus on continuous improvement and early detection of supply chain issues; and
• Logistical and regulatory challenges make it difficult for the market to recover from a disruption.⁴

The report also recommends enduring solutions:

• Creating a shared understanding of the impact of drug shortages on patients and the contracting practices that may contribute to shortages;
• Developing a rating system to incentivize drug manufacturers to invest in quality management maturity for their facilities; and
• Promoting sustainable private sector contracts (e.g., with payers, purchasers, and group purchasing organizations) to make sure there is a reliable supply of medically important drugs.⁴

The FDA stated that they have received the letter and will respond to the inquiry directly, with a staff-level briefing expected by Nov. 9 and documents by Nov. 16.³

References

1. Comer J. McClain L. Letter (PDF) to FDA Commissioner Robert Califf. November 2, 2023.

2. A tale of 2 industries: FDA’s Robert Califf weighs in on ‘fundamental problem’ causing so many shortages. Fierce Pharma. August 22, 2023. Accessed November 7, 2023. https://www.fiercepharma.com/pharma/tale-two-industries-fdas-califf-rails-against-innovator-and-generic-drug-pricing

3. House GOP opens probe into FDA response to drug shortages. The Hill. November 3, 2023. Accessed November 7, 2023. https://thehill.com/policy/healthcare/4292104-house-gop-opens-probe-fda-response-drug-shortages/

4. Report | Drug Shortages: Root Causes and Potential Solutions. FDA. Accessed November 7, 2023. https://www.fda.gov/drugs/drug-shortages/report-drug-shortages-root-causes-and-potential-solutions