FDA Forming Working Group on Imported Prescription Drugs to Address Price Spikes

The working group will examine importation of drugs that have seen significant price increases or significant access challenges for patients, and it will examine the potential to promote competition for drugs that are off-patent or off-exclusivity and produced by one manufacturer.

At the request of U.S. Health and Human Services Secretary Alex Azar, FDA Commissioner Scott Gottlieb is setting up a working group to examine how to safely import prescription drugs from other countries in the event of a dramatic price increase for a drug produced by one manufacturer and not protected by patents or exclusivities, the agency announced July 19.

"We look forward to working with Commissioner Gottlieb and the FDA to explore how importation could help address price hikes and supply disruptions that are harming American patients," said Azar. "We have seen a number of both branded and generic examples in recent years where a single manufacturer dramatically hikes the price for a drug unprotected by patent or exclusivities. In the 2015 case of the drug Daraprim, we saw the list price of a drug approved by the FDA in 1953 increase by more than 5,000 percent. Safe, select avenues for importation could be one of the answers to these challenges. When HHS released the President's Blueprint for putting American patients first, I said we are open to all potential solutions—assuming they are effective, safe for patients, and respect choice, innovation, and access.

"Importation may well fit that bill in some instances. We look forward to working with Commissioner Gottlieb on this issue and appreciate the voluminous work FDA has done to increase competition in America's drug markets," he added.

The working group will examine importation of drugs that have seen significant price increases or significant access challenges for patients, and it will examine the potential to promote competition for drugs that are off-patent or off-exclusivity and produced by one manufacturer.

Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • Easy to Use Safety Incident App

    Record incidents on the go with IndustrySafe’s mobile app. Collect data for multiple types of incidents including including near misses, vehicle and environmental incidents, and employee and non-employee injuries; at job sites and remote locations—with or without web access.

  • Safety Training 101

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. IndustrySafe is here to help. We put together a resource that’s easy to digest so you can get answers to your training questions and ensure you're complying with OSHA's standards.

  • Conduct EHS Inspections and Audits

    Record and manage your organization’s inspection data with IndustrySafe’s Inspections module. IndustrySafe’s pre-built forms and checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Track Key Safety Performance Indicators

    IndustrySafe’s Dashboard Module allows organizations to easily track safety KPIs and metrics. Gain increased visibility into your business’ operations and safety data.

  • Industry Safe
comments powered by Disqus