During his first year in office, President Donald Trump took no direct action to lower the country's sky-high prescription drug prices, something that he vowed to tackle during the 2016 campaign. But Trump's man running the Food and Drug Administration is striving to move the needle in this area with a concentrated push toward expanding generic drug competition.
As FDA commissioner, Scott Gottlieb can't tell drug makers how much to charge for their products, unlike the top officials regulating the drug industry in many other developed countries. But when he was confirmed back in May, Gottlieb identified generics as the space where the agency could potentially have the most impact in the quickest way - both by making it easier for companies to develop generic drugs and nudging generics into markets with no existing competition.
"I think the greatest opportunity to have a very palpable impact on people's lives is through trying to create greater access," Gottlieb said in a recent interview with us. "The low-hanging fruit was on the generic drug side."
Generics were also a priority for Gottlieb's predecessor, Rob Califf, who was troubled by the massive backlog of generic drug applications, a list that reached longer than 2,800 pending applications in 2012. The backlog is now down to the low 100s, according to Gottlieb, but he wants to essentially eliminate it so companies can obtain immediate review once they apply.
Part of reaching that goal involves shortening the typical review period, which several years ago averaged as much as 31 months. The FDA has made strides since then, but Gottlieb says he's aiming for an average review length of just 10 months.
At least in terms of its generic drug goals, the agency ended 2017 with a bang. In October, the FDA announced it had approved 763 generic drug applications so far that year, exceeding previous records of 651 approvals in 2016 and 492 approvals the year prior.
Last week, Gottlieb tweeted that generic approvals had exceeded 1,000 for 2017 "Thank you to #FDA team for their dedication to public health: In 2017 the agency approved the highest ever number of generic drugs (>1,000); the most ever novel drugs (46); the most ever novel devices, and the first ever gene therapies"
In a year where health-care policy could hardly have been more contentious on Capitol Hill, Gottlieb has received unusually rave and bipartisan reviews for his approach.
Andy Slavitt, former head of the Centers for Medicare and Medicaid Services under President Obama, tweeted "Congratulations to @SGottliebFDA and all the people of the @US_FDA and thank you for service."
There's no denying Gottlieb's a conservative who opposes government price controls - he most recently served as a fellow at the conservative think tank the American Enterprise Institute - but he says the government needs to do a much better job of promoting competition among drug makers.
"Companies sometimes go through very torturous processes to bring a generic drug onto the market," Gottlieb said.
For example, the FDA has started prioritizing applications for generics where there's just one competitor on the market. In June, Gottlieb instructed the FDA to publish and regularly update a list of approved drugs that are no longer protected by patents or exclusivity periods and have no generic competition - in other words, drugs that could be highly attractive to a generic developer.
Gottlieb tweeted "Today FDA issued generic drug guidance, provides path for priority review, cut review time 2 months Expands access"
The agency has promised to expedite review of applications for any drugs on this list, with an eye toward creating more generic choices for consumers who currently have access to only one branded option.
"Hopefully it will have some immediate impact," Gottlieb said.
Gottlieb said he's also trying to ease the ability of companies to prove their generic version of an already approved drug is the same as the branded drug they're trying to emulate. Branded companies often game the system by making it hard for generic companies to buy the 2,000 to 5,000 doses of a drug they need to prove it's the same makeup.
Gottlieb said he finds the practice so "pernicious" because it undermines the U.S. system of market-based drug pricing.
"We accept the prices, but the flip side of that is we have an expectation that there will be vigorous competition," Gottlieb said.