The 21st Century Cures project, led by Energy and Commerce Committee Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO), is an extraordinarily important endeavor that recognizes the need to modernize our regulatory structure if we are to achieve the major promises of 21st century medicine.
“If we want to save more lives and keep this country the leader in medical innovation, we have to make sure there’s not a major gap between the science of cures and the way we regulate these therapies,” the House Energy and Commerce Committee explains. “We are looking at the full arc of this process – from the discovery of clues in basic science, to streamlining the drug and device development process, to unleashing the power of digital medicine and social media at the treatment delivery phase.”
Over the last year, the committee has gathered recommendations from expert witnesses and consumers around the country during dozens of working sessions and round tables, and has worked hard to garner bi-partisan support for the plan. The first committee mark-up session is scheduled for tomorrow, and Chairman Upton hopes to get a bill to the floor early this summer.
We will examine in a subsequent post the many good provisions of the legislation, but one stands out that the committee would be well advised to avoid.
The controversial provision is referred to as “forced sale,” and it strikes at the heart of patient safety.
Here is the back story: In 2007, Congress gave the Food and Drug Administration authority to work with drug developers to develop Risk Evaluation and Mitigation Strategies (REMS) programs to help manage drugs with known, potentially serious risks, such as organ damage, serious infection, or birth defects. The strictest REMS protocols could require the developer to keep a registry of all patients taking the drug, to certify all prescribers and dispensers of the drug, to counsel patients to assure compliance with the protocols, or restrict distribution in the interest of patient safety.
Generic drug manufacturers want the Energy and Commerce Committee to include in the Cures legislation a new requirement for high-risk drugs that have distribution restrictions. The proposal would force innovator companies to sell their drugs to generic competitors without imposing similar safety obligations on them.