• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

FDA’s Gottlieb: Drug shortages are an ‘inevitable consequence of an imperfect system’

June 1, 2018 By Sarah Faulkner

PillsWhen doctors and nurses are faced with a shortage of medically necessary drugs, they are forced to make challenging decisions about how to ration whatever they have left.

FDA commissioner Dr. Scott Gottlieb is looking to identify ways that the U.S. regulatory agency can help prevent and predict these shortages. In a statement this week, Gottlieb revealed that he’s even considering working with Congress to expand the FDA’s existing authority to require pharmaceutical manufacturers to conduct shortage risk assessments.

Most drug shortages are due to disruptions in the supply chain, the FDA chief noted, not product discontinuation. Beyond manufacturing and quality issues, a shortage of raw materials sourced from one supplier can affect production for multiple drugmakers if they all depend on the same supplier.

Gottlieb said drug shortages can also come about thanks to decisions relating to a company’s bottom line.

“Manufacturers often make production decisions based on business considerations, such as a product’s profitability, manufacturing costs, distribution quotas and patent life. We know that business decisions at any point along the drug supply chain can lead to shortages. Historically, many drugs in short supply have been low-profit generic medications, for which the investment needed to ensure continued production can be less than that for higher profit products,” he explained.

To help mitigate and prevent drug shortages, Gottlieb called on manufacturers to notify the FDA as soon as they experience any disruption that is likely to impact their supply of a given drug. While this is already required under the Food and Drug Administration Safety and Innovation Act of 2012, Gottlieb said that often manufacturers “abruptly discontinue, limit, or delay production under circumstances outside those for which they are specifically required to provide advance notice to the agency.”

“There are other times when companies notify the FDA of potential supply disruptions, but don’t provide enough details to allow us to make the fullest use of our resources to address the shortage. We need to know as much as possible about these shortages,” he added.

Gottlieb also said that the agency will accelerate inspections of production facilities if a new facility is needed to remedy a shortage. The FDA plans to speed up its review process for new or generic drug applications that are designed to serve as an alternative therapy for a product that is in short supply.

To curtail the potential impact of drug shortages, manufacturers need to be better prepared, according to Gottlieb.

“Shortages are an inevitable consequence of an imperfect system. With better planning, we can minimize shortages throughout the supply chain. But, in the near term, we won’t be able to fully eliminate the possibility that new shortages will arise. Meaningfully impacting the structures and market challenges that can give rise to shortages will require more coordination among public and private stakeholders,” he said.

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Filed Under: Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance Tagged With: FDA

IN CASE YOU MISSED IT

  • Elixir Medical reports sustained durability with bioadaptor compared to Medtronic stent
  • Senseonics closes public offering, private placement with Abbott
  • Embecta eyes shift from insulin delivery to broader medical supplies focus
  • Medtronic earns expanded CE mark for Prevail paclitaxel-coated balloon
  • Sequel Med Tech to pair automated insulin delivery system with Abbott’s future dual glucose-ketone sensor

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS