For full functionality of this page it is necessary to enable JavaScript. Here are the instructions how to enable JavaScript in your web browser 21st Century Cures Act Calls for 21st Century Recall Preparation

21st Century Cures Act Calls for 21st Century Recall Preparation

The 21st Century Cures Act has cleared a major Senate hurdle and is expected to be signed into law by President Obama. Among other provisions, the bill will fast-track the approval process for certain drugs and medical devices. The $6.3 billion package includes “nearly $5 billion for the National Institutes of Health to accelerate research into major diseases, including $1.8 billion for Vice President Joseph R. Biden’s “moonshot” project on cancer, and $500 million for the Food and Drug Administration to make its approval process more efficient.”

The act gives hope to many patients who don’t have time to wait for lengthy testing and approvals. At the same time, many observers have pointed out the potential that these innovative new drugs and devices could come with more complications than those that have undergone extensive testing, which could lead to more recalls.

Now is a good time for pharmaceutical and medical device companies to revisit recall preparation, including:

  • Internal teams. Too often, an employee charged with managing recalls moves on from the company and the role is not assigned to someone else. That leaves a significant void when another recall occurs. Companies should ensure team members have a clear understanding of their responsibilities.
  • Consignee data. In the event of a drug or device recall, hospitals and other medical offices will typically need to be notified directly. If facilities have changed locations, that data may be out of date. It is important to cross check contact information across systems or employ a recall partner to update the data.
  • Recall plans. In many cases, existing recall plans are not as robust as necessary. The best way to ensure recall plans are up-to-date is to test it with a mock recall. Many companies find they are able to execute one or more steps of the recall life cycle effectively, but discover gaps in other areas. In those cases, it is crucial to fix those gaps and retest regularly.

Many in the industry are optimistic about the promise of the 21st Century Cures Act. But it also means companies will be entering into uncharted waters. To successfully navigate those potentially choppy seas, they must ensure lifeboats are adequate – and that means testing and updating recall plans.

Get Recall Updates and More

Stay on top of the latest in Recalls with Expert Solutions! Our Quarterly Recall Index insights keep you up-to-date with recall trends, while our blogs and Expert Spotlight provide timely information from industry specialists.

Subscribe Now
Stericycle ExpertSOLUTIONS

Stericycle Expert Solutions focuses on helping customers by providing proven, customer-centric, scalable services that protect people and brands, promote health and safeguard the environment.

Find Out More

Get In Touch

If you're ready to get started with our extensive suite of services then contact us today. We have a team of experts ready to assist you!

Contact Us today