FDA Seeks to Address Drug Shortages


Some of the oldest and most important drugs have suddenly been subject to very short supplies.

The ongoing drug shortage problem in this country has been a hot button issue as of late—and rightfully so. Because supply has not kept up with demand, many Americans are unable to access the medications they need to thrive.

As part of an ongoing effort to better understand the reasons for drug shortages and devise plans of action to rectify the situation, the US FDA FDA, in conjunction with the Duke Margolis Center for Health Policy, held a public meeting on November 27 that featured multiple panels of experts from the FDA, universities, pharmaceutical corporations, insurance agencies, and health-related associations.

FDA commissioner Scott Gottlieb, MD, served as the event’s keynote speaker and began the meeting by addressing the severity of the issue and the repercussions ongoing shortages have on public health.

“The question we constantly get is this one: Why are some of the oldest and most important medicines—drugs that used to be very cheap— suddenly subject to very short supplies, where the prices often get hiked sharply, if the medicines can be gotten at all? It’s question borne of a lot of appropriate frustration, from doctors, patients, and policymakers. Despite a lot of focus on these problems, we don’t have very good answers.”

Dr. Gottlieb went on to concede that no easy solutions exist, but that the FDA and the Interagency Drug Shortages Task Force it has established are committed to fixing things for good. “In my view, it’s a problem borne of failures of economics and policies that span many years,” he said. “And the extended failings of policy have left us with a sticky morass of protracted woes related to the way these products are manufactured and the way they’re reimbursed; which sometimes leaves very little margin for error.”

With so many facets to the mounting problems that cause and are caused by these drug shortages, Dr. Gottlieb called upon the day’s presenters to share their insights into why the system has repeatedly failed and offer any plausible suggestions they may have towards finding a solution.

As part of a panel discussion on Manufacturing & Supply Challenges, Daniel Motto of Hikma Pharmaceuticals PLC recommended considering how companies can be better incentivized to produce proven, life-saving medicines, especially those that are generic and commonly used.

Other solutions offered included making information about who manufacturers a drug available to stakeholders. “If you can’t measure it, you can’t monitor it, and you can’t manage it,” said Ernst Berndt a Professor of Applied Economics at the Massachusetts Institute of Technology.

“One promising option would be to consider how to stockpile critical medicines in a way that would allow manufacturers to be able to commit to price and volume levels in contracts with purchasers,” suggested Navin Katyal, General Manager, Pfizer Injectables.

Recommendations for how to address the issue have not been limited to the panel discussions. In advance of Tuesday’s meeting, The American Hospital Association (AHA), American Society of Anesthesiologists, the American Society of Clinical Oncology, American Society of Health-System Pharmacists (ASHP), and the Institute for Safe Medication Practices released a series of 19 recommendations that they believe will allow healthcare providers to prepare for an imminent shortage. Among their recommendations, the coalition called on the FDA to share information on the type of products that may be impacted during a public health emergency and the expected duration of the impact on the entire drug supply chain.

“Achieving lasting solutions that ensure life-saving drugs are always available to meet the needs of patients will require fundamental changes to the systems used by government and industry that currently allow drug shortages to persist,” said Paul W. Abramowitz, PharmD, ScD, FASHP, the CEO of ASHP. “These recommendations are an urgent call to action to take immediate steps to strengthen the drug supply chain so that patients have reliable access to the medications they need.”

If you are interested in learning more about the drug supply issues, watch Pharmacy Times' live coverage of the ASHP meeting, where this topic is expected to be discussed.

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