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WASHINGTON, D.C. – Congressman Brett Guthrie, who is the Republican Leader of the Energy and Commerce Committee’s Health Subcommittee, introduced the Pre-approval Information Exchange Act, a bill to help patients gain access to treatments and medical devices more quickly.

“We should be doing all we can to get treatments to patients as quickly and as safely as possible. That’s why I’m proud to introduce the Pre-approval Information Exchange Act to help address what’s known as the ‘Valley of Death’, which is the time period a drug or a device is approved by the Food and Drug Administration and when it is covered by an insurer.  The goal of this legislation is to have drugs and medical devices covered by payors once the product is approved by the FDA by allowing drug and device companies to share key health care economic information with health insurers and other payors ahead of approval. As the Republican Leader of the Energy and Commerce Committee’s Health Subcommittee, I’m proud to introduce this commonsense and targeted solution to ensure patients can access safe and cutting-edge medical innovation more quickly,” said Guthrie.

The Pre-approval Information Exchange Act would allow drug and device sponsors to share key health care economic information, including pre-clinical trial results and other important economic information, with health insurers and other payors before a drug or device is approved by the Food and Drug Administration (FDA).

Permitting certain communications between a drug or medical device company and payors would help reduce the time period that a product is approved by the FDA but not yet covered by an insurer. The Pre-approval Information Exchange Act would also give drug or medical device companies the ability to share this critical information with payors on investigative uses of already approved FDA products.

Guthrie introduced the Pharmaceutical Information Exchange Act in 2017, which is a similar bill to permit certain communications between payors and a company with a soon-to-be FDA approved medical device or drug. The FDA released guidance in 2018 on permissible communications, and the Pre-approval Information Exchange Act would codify this guidance into law, ultimately providing needed predictability for both payors and sponsors to engage in these discussions and work to get treatments to patients more quickly.

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