- After nearly two years as head of the Food and Drug Administration, Scott Gottlieb's answer for solving the persistent problems of drug affordability and access remains the same as when he was sworn in: increasing market competition for both products and price.
- "We don't always have the product competition that we expect," Gottlieb said in remarks at the Brookings Institution in Washington, D.C. on Tuesday. "And when we have the product competition we expect, we don't always have the pricing mechanisms in the marketplace that allow that competition to actually deliver savings."
- Gottlieb will step down as FDA chief on April 5, having announced his planned resignation earlier this month. As commissioner, he took a more vocal approach to addressing drug pricing issues than past FDA leaders — a legacy now left to Ned Sharpless, the National Cancer Institute director tapped to be the agency's interim head.
Increasing — and improving — competition for pharmaceuticals framed many of the drug-oriented initiatives the FDA has launched under Gottlieb.
Chief among those efforts was a push to approve more generic drugs, something the FDA achieved by waving through record numbers of the copycat medicines in 2017 and 2018. But Gottlieb also made frequent use of his public position to criticize drugmaker "gaming" of the system to artificially delay or hamstring competition.
Those tactics haven't gone away, he recently told BioPharma Dive in an interview, but more egregious examples have become rarer.
Yet, the FDA has little power to affect how drugmakers price their products once approved, and pressure has ramped up for broader legislative solutions to the contentious issue.
Speaking at the Brookings Institution during one of his final public appearances as FDA commissioner, Gottlieb kept the focus on competition, pointing to three market failures — lack of product competition, lack of price competition and misaligned discounting.
"When you finally have product competition and price competition, the discounting is in the form of back-ended rebates that don't benefit the consumer who is [paying] out-of-pocket for the medicine," said Gottlieb.
The Trump administration is currently seeking to reshape how rebates are paid in Medicare, aiming to channel more of those savings directly to patients paying for medicines — a potentially sweeping change that's sparked significant pushback. Currently, insurers often use rebates to lower premium costs across the board for healthcare plan members.
At Brookings, Gottlieb largely sidestepped a question on whether the U.S. should enact broader changes to how medicines — in particular biologics — are granted market exclusivity.
"There are still problems of affordability with patients having a difficult time accessing medicines," Gottlieb said. "But I think that a lot of the problems, or market failures, aren't related to patent terms."
Gottlieb did acknowledge, however, that in the case of biologic drugs, market exclusivity often extends beyond the 12 years set by law due to encircling rings of protective patents.
This issue has become a particular focus of lawmakers and public advocacy groups as drugs like AbbVie's Humira (adalimumab) look set to avoid competition for years beyond that timeline.
Biosimilars are supposed to solve that issue, but so far have had a limited impact in the U.S. due to contracting and patent-related legal hurdles.