Amarin Corp Plc (AMRN)

[Chris2125]

FDA press on labeling/RWE

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm605539.htm


Few of the highlights below from link...Labeling and RWE...something Amarin has been speaking about for over a year...

“However, when brand reference drugs voluntarily withdraw their marketing applications and therefore stop updating their labeling, FDA loses a mechanism to update generic labels.

This framework can stymie the updating of generic drug labels.

Having out of date labels, in turn, can depress use of generic drugs. By one rough estimate, there are about 5,600 reference-listed drugs that correspond to generic medicines. And of these reference drugs, 1,170 are tagged as discontinued or withdrawn by their original, branded sponsors for reasons other than safety or effectiveness.

“Real-time surveillance is first and foremost about safety.

But having a real-time, post-market, real-world experience system will also give us additional ways to use real world evidence to expand what we know about the effectiveness of new products.

And new products are often safer because they can be designed to address safety issues identified through better surveillance.

For example, we can better utilize electronic healthcare data to broaden the indications for use of approved medical products, eventually perhaps conducting much of late stage development in the “real world” making our pre-market development process more efficient.

And, as always, we continue to learn about medical products after marketing approval.

No matter the design or size of clinical trials, we can never answer – or anticipate – all the questions we may have before we approve a new product.

Thus, we must rely on post-market data tools.

The better those tools are, the more confidence we can have in the ability for questions to be answered in a real-world setting.

The FY 2019 Budget includes $100 million to advance the use of real-world experience to inform patient care and provide efficient and potentially lower cost ways to develop clinical data to expedite medical product development.

The proposal would create the capability to conduct near-real-time evaluation down to the level of individual electronic health records for at least 10 million individuals from a broad range of healthcare settings.

This will enrich our tools for evaluating safety and can reduce the cost of medical product development.

To see how this new system can improve product review, consider the steps we’re taking to modernize our approach to the review of medical devices and assure their safety.

This Budget proposal builds upon our efforts as part of the NEST, which is a public private partnership under the Medical Device Innovation Consortium.

With the new investment, FDA will be able to link across data sources, including electronic health records to capitalize on the opportunity to evaluate broader sets of endpoints that are not easily accessible and utilized today. This will provide for a fundamental shift from passive to active device surveillance.

These are transformative initiatives that can modernize the foundation of FDA oversight and improve patient safety.

Your support, through appropriations, allows us to modernize how the FDA fulfills its vital consumer protection mission and provide meaningful benefits for patients.

I look forward to explaining our Budget request in more detail and answering any questions.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”