AMCP Urges Members to Support Pre-Approval Information Exchange Legislation

Members of the Academy of Managed Care Pharmacy (ACMP) were urged to support the Pre-approval Information Exchange (PIE) Act during a panel discussion that also focused on the upcoming midterm election.

“Volume matters to lawmakers. If you haven’t taken action yet, we really do urge you to do so,” said Jennifer L. Mathieu, vice president of policy and government relations at ACMP and the moderator of a session titled “Midterm Election Outlook and Its Health Care Implications,” during the AMCP Nexus conference at the Gaylord National Convention Center in National Harbor, Maryland, on October 12, 2022.¹

During the session, Mathieu asked audience members to send a text to the ACMP that brought up a link with a pre-written message of support for the bill that could be sent to specific members of Congress once a zip code was added.

Under the proposed legislation, which was introduced by Rep. Brett Guthrie (R-KY) in March 2022, economic, scientific, or other product support information exchanged between drug manufacturers and health care entities—such as pharmacy benefit managers—about drug products before regulatory approval is not considered misbranded or prohibited premarket promotion if it relates to the product’s investigational use and meets other specified criteria, according to the language in the bill.

The ACMP has called the PIE Act a top federal priority.

“The PIE Act of 2022 is an important bipartisan bill that will enhance patient access to emerging pharmaceuticals and devices by authorizing pharmaceutical manufacturers to proactively share certain health care economic and scientific information about products with health payers ahead of [FDA] approval,” according to the ACMP’s website.²

“Although the FDA finalized guidance in 2018 regarding PIE, confusion remains around the circumstances under which manufacturers can provide information prior to approval and the nature of the information that can be provided. AMCP worked closely with Rep. Guthrie to ensure that the PIE Act will clarify the scope of PIE and resolve inconsistencies between the guidance and relevant statutory law,” the ACMP said.

The House of Representatives passed the Food and Drug Amendments of 2022, which includes the PIE Act, on June 8, 2022, by a vote of 392-28, and is awaiting Senate approval.

Meanwhile, 2 political consultants on the panel provided insights into the upcoming midterm elections, saying that the key Senate races to watch are in Arizona, Georgia, Nevada, Ohio, Pennsylvania, and Wisconsin.¹

“At the end of the day, it’s the economy that dictates the outcomes of elections,” said Andrew McKechnie, consultant at Tiber Creek Group, a government relations and lobbying firm in Washington, D.C., noting that polls show the Democrats will take the Senate, while the Republicans will likely gain control of the House.

This year’s election season is challenging to predict because of additional factors, including the US Supreme Court’s decision in June 2022 to overturn Roe v Wade and former President Donald J. Trump’s continued presence on the political scene.

“There’s so many factors swirling out there right now,” McKechnie said.

“Donald Trump is still the most popular person in the Republican Party. He’s certainly impacting races, and he raises a huge amount of money,” McKechnie said.

“[Trump] can make or break a race, and some of the people he supported in the primaries are struggling in the general election,” the consultant said.

McKechnie’s colleague, Alix Burns, president of Tiber Creek Group’s Bay Bridge Strategies, said that the 2022 midterm elections are performing more like a presidential election, noting that President Joseph R. Biden’s approval ratings, which have improved recently, are directly tied to the economy.

Both McKechnie and Burns said that the president’s broad new law, the Inflation Reduction Act, which aims to, among many other goals, allow Medicare to negotiate prices for high-cost drugs and establish a $35 cap for a month’s supply of insulin, was a big win for Democrats. But the challenge for the party is that many aspects of the law are not scheduled to take effect for at least several years.

“Drug prices are going to be lower; is that connecting? How does that messaging work?” Burns said.

The consultants also discussed polling and how that has changed, in large part because of COVID-19. Telephone polls are not seen as reliable as in the past and some polling has moved to social media.

And though many candidates have raised a huge amount of money, particularly on the Democratic side, it does not necessarily mean they will all win their races, Burns said.

“I believe the latest I saw is that $9 billion will be spent on these elections,” McKechnie said.

References

1. Burns A, McKechnie A. Midterm election outlook and its health care implications. Presented at: AMCP Nexus; Gaylord National Convention Center in National Harbor, Maryland: October 14, 2022.

2. Pre-approval Information Exchange (PIE). Academy of Managed Care Pharmacy. Accessed October 14, 2022. https://www.amcp.org/policy-advocacy/legislative-regulatory-issues/pre-approval-information-exchange