E&C Health Subcommittee Addresses Patent Exclusivity, Drug Pricing During 21st Century Cures Hearing

Today, the House Energy and Commerce’s subcommittee on Health held a hearing on the 21st Century Cures Initiative entitled, Examining the Role of Incentives in Advancing Treatments and Cures for Patients. With Republicans focused on the theme of extending patents for drug and device manufactures and Democrats primarily concerned with spending for “basic science” at the National Institutes for Health (NIH), Members voiced their interest in spurring scientific advancement for both chronic and rare diseases.

Two additional topics of discussion included the length of time it takes the Food and Drug Administration (FDA) to approve new drugs and devices and the amount of post-approval data required by Centers for Medicare and Medicaid Services (CMS) to authorize reimbursements for new treatments. The subcommittee as a whole commended the Hatch-Waxman Act, which increased the length of time for drug patents once they had been approved by FDA (passed in 1984), but Republicans often quoted Sen. Orrin Hatch’s (R-UT) recent call for a review of the exclusivity terms of his three-decades old law during this three hour long hearing. Rep. Henry Waxman (D-CA), along with other Democrats present, called for either maintaining the current patent structure or increasing the opportunities for generic drug makers to come to market faster. Each position was touted as the best way to incentivize innovation and thereby result in more treatment options for patients.

If you are interested in additional details about this hearing, please contact Jessica Golibart (jgolibart@thornrun.com).