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WASHINGTON, D.C. - Congressman Brett Guthrie (KY-02) reintroduced the Pre-approval Information Exchange Act with U.S. Representatives Anna G. Eshoo (CA-18), Morgan Griffith (VA-09), Scott Peters (CA-52), Michael C. Burgess, M.D. (TX-26), and Doris Matsui (CA-06) to help patients more quickly access new drugs and medical devices approved by the Food and Drug Administration (FDA).

“The goal of the Pre-approval Information Exchange Act is to get newly FDA-approved treatments and devices to patients faster. Early communications between a payor and a drug or device manufacturer that this bill would permit under law can help reduce the time lag between FDA approval and a payor covering the drug or device so that patients can access cutting-edge medical innovation sooner. I thank my colleagues on both sides of the aisle for supporting this commonsense solution that will help improve patients’ lives,” said Guthrie.

“Patients often wait for their health insurer to cover a new FDA-approved treatment. The PIE Act will help shorten that wait by allowing drug and device manufacturers to share more information with health insurance companies before a treatment is approved by the FDA. I’m pleased to join Rep. Guthrie in introducing this commonsense, bipartisan legislation which will save patients money, time, and anxiety by helping them get new treatments sooner,” said Eshoo.

“The lag between when a drug or medical device is approved by the FDA and when a payor covers it can eat up precious time for treating a medical condition. Our bipartisan bill would help patients by streamlining the process for them to receive FDA-approved treatments. This reform would get safe drugs and devices to patients faster, and I am pleased to join my colleagues in introducing it,” said Griffith.

“Currently, producers of newly- or soon-to-be- FDA approved medicines and medical devices are prohibited from sharing vital health care economic datapoints with insurers as they establish their coverage policies,” said Peters. “This can prolong coverage decisions, cause lengthy treatment delays, and reduce access for patients seeking innovative medical care. Ensuring payors have more accurate health care economic information will help patients access treatments more quickly by speeding up coverage decisions on FDA-approved medicines.”

“The Pre-approval Information Exchange Act (PIE) helps patients get the medications they need by sharing information earlier in the FDA approval process,” said Burgess. “By reducing the time between FDA approval, this proactive release of information speeds up patient access to cutting edge, potentially lifesaving treatments. This Act promotes efficiency in the FDA approval process that will lead to better outcomes for American patients.”

“When it comes to getting the health care we need, there is no time to spare. From early detection and intervention, to access to the latest treatments and therapies, removing barriers to care improves health outcomes. Expediting health coverage of innovative medications can be life-saving, especially for Americans with rare diseases. That’s why I am pleased to join my colleagues in introducing the PIE Act, bipartisan legislation that will help strengthen the efficiency of the drug approval process and increase patient access to new and novel treatments,” said Matsui. 

After a drug or medical device is approved by the FDA, patients often have to wait for their payor to cover the new medical innovation. The goal of the Pre-approval Information Exchange Act is to reduce the amount of time between the FDA approving a drug or medical device and the FDA-approved medical innovation being covered by a payor. This bill would do this by permitting a drug or medical device company to share certain health care economic information with payors about investigative products before the products are approved by the FDA.

The Pre-approval Information Exchange Act passed in the House and passed unanimously in the Energy and Commerce Committee as part of the FDA Act of 2022.

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