The next FDA chief has big pro-consumer shoes to fillScott Gottlieb, M.D.
During his Senate confirmation hearing in April 2017, Dr. Scott Gottlieb committed himself to “the gold standard of safety and efficacy.”
Over the past two years as head of the Food and Drug Administration (FDA), Commissioner Gottlieb has made good on that promise, and his tenure has been a model for future FDA chiefs.
To his great credit and the benefit of consumers, Gottlieb, whose tenure at the agency ended recently, pursued policies that encouraged competition and choice.
In fall 2016, months before his appointment as FDA chief, Gottlieb foreshadowed his approach to the FDA in testimony at a Senate hearing on the EpiPen price scandal.
Pharmaceutical company Mylan, you might remember, had increased the price of EpiPen two-packs from $100 in 2009 to more than $600 by 2016, finally prompting lawmakers in both the House and Senate to organize hearings.
In this highly charged environment, Gottlieb delivered his testimony. Avoiding the easy outrage, he took a more measured approach. Gottlieb cast a critical eye on regulators and laid part of the blame for the “craziness and inefficiency in how drugs are priced” with the FDA itself.
The agency’s failure to approve more generic alternatives, Gottlieb pointed out, meant Mylan and companies like it were able to capture substantial portions of their markets, making them “almost the only game in town.”
The FDA itself was complicit in creating the competitive vacuum that allowed Mylan to artificially inflate the prices on its life-saving drug.
“These missteps underscore more systemic problems with the regulatory process that governs the review and approval of generic copies of complex drugs,” Gottlieb said in his testimony, later adapted for Forbes. “Congress should modernize the generic drug framework to accommodate complex drugs.”
From his perch atop the FDA, Gottlieb worked to do just that.
In the last fiscal year, the agency, as part of a general attempt to lower pharmaceutical prices, approved 971 generic drugs, a new record, and 937 the year before. These marked a bump up from the 835 generics approved during the Obama administration’s last full year.
Gottlieb also prioritized smoothing the approval process for new drugs and medical devices, greenlighting record numbers for each over the past two years.
The FDA approved 59 novel medications in 2018, compared to 22 in the last year of the Obama administration and 45 the year before that. Between 2017 and 2018, the agency approved more than 200 new medical devices.
Under Gottlieb’s leadership, the FDA was also quick to embrace Congress’ “Right to Try” legislation, which created a new pathway for terminally ill patients to access treatments waiting for FDA approval.
The agency has also prioritized expanding access to so-called “orphan drugs” — pharmaceuticals commercially underdeveloped because their high costs make profitability less sure. The FDA was able to clear its entire backlog of orphan drug reviews last year thanks to a program kickstarted shortly after Gottlieb took over as commissioner.
This record is impressive, which, in a way, makes the minor blemishes on Gottlieb’s legacy that much more conspicuous.
Maybe the most vexing position adopted by the FDA during the Gottlieb-era was its decision to review rules for plant-based alternatives to cow’s milk.
Under the FDA’s proposal, labeling dairy-free products as “milk” would be illegal, even if, as Sen. Mike Lee (R-Utah) has pointed out, consumers don’t seem particularly harmed, confused or concerned about calling ground up bits of almonds mixed with water “milk.”
Without solid empirical evidence of consumer harm, the FDA shouldn’t be considering rules that would force coconut milk, cashew milk, rice milk, etc., into expensive rebrandings. Whoever President Trump appoints as the next FDA commissioner should send this bovine boondoggle out to pasture.
But this criticism is mostly a nitpick. Gottlieb’s FDA was pro-consumer, and his successor should strive to continue that legacy. Keeping up the pace on both generic and new drug approvals is one way to do that. Continually working to speed up the approval process for innovative treatments of today’s worst diseases is another.
When Gottlieb announced his resignation last month, a veritable chorus, which included the president, acclaimed his performance.
Looking back over his two years as FDA chief, it’s now clear that Gottlieb’s pledge to uphold a “gold standard of safety and efficacy” was not empty rhetoric but a real commitment. The next FDA commissioner has big shoes to fill.