“We are taking on an individual-by-individual basis what’s the regulatory need for anything in China … versus what are the personnel risks associated,” he said.
Monitoring the the situation in China could soon get trickier as the State Department expands mandatory evacuation from affected areas of the country.
The coronavirus also broke out in an election year when President Donald Trump wants to deliver on his promise to bring down drug prices — not traditionally the province of the FDA, a regulatory agency designed to focus on safety and efficacy.
“If my patients couldn’t get access to something because of cost — that was a real problem for me as a doctor. Now I’m on the other end of that, but what can we do to make sure that that pipeline flows in the best way possible?” said Hahn, 60, an oncologist, researcher and Washington newcomer.
Hahn was confirmed as commissioner on Dec. 18, the night before the administration announced its plan to let states import cheaper medicines from Canada — an approach that prior FDA commissioners opposed over fears it would jeopardize the safety of the drug supply. Trump has endorsed letting states such as Florida do this.
“There is a compelling reason that the American people want us to consider this and so we’re going to have to figure this one out and balance both of those issues,” Hahn said, referring to safety and affordability.
The FDA for years has mostly stayed out of the debate around drug prices; the agency doesn’t regulate the cost of medicines or health insurance coverage. But Hahn talked up FDA’s role in getting prices down by approving more generics, acknowledging that “the American people are expecting us to do more.” Trump has touted the FDA’s record on boosting competition via generic approvals.
As FDA works on finalizing the importation rule, Hahn said the agency will be open to addressing criticism that states can’t save money bringing in drugs from Canada if the pathway is too burdensome. But he stressed safety is tantamount. “Our primary concern is the protection of the drug supply,” he said.
Hahn said he has also talked with CMS Administrator Seema Verma about addressing costs of new brand-name products that are approved with limited data sets, similar to the way CMS decides to cover some medical devices. That approach — known as coverage with evidence development — lets CMS cover a new product on the condition that manufacturers keep providing data.
FDA has not done that, but new medicines are increasingly being approved on smaller clinical trials without hard data on clinical benefits — and can come with six-figure price tags.
As an academic, Hahn had co-written an editorial suggesting that payments for newly approved radiation oncology devices could be linked to older products until enough evidence builds up to show that the new products are superior. Only then would manufacturers have more pricing leeway.
“It’s a CMS call about coverage with evidence development, but I do think in this world where we are concerned, and rightfully so, about the cost of medicine and health et cetera, that we should be looking at all avenues to approach that,” he told POLITICO.
Over the last few years, some critics have said the FDA is overcorrecting and moving too quickly to approve drugs without adequate evidence. But Hahn did not indicate he would put the brakes on.
“At the end of the day there is this balance between the gold standard and being efficient and getting things in people’s hands I’m totally confident in the agency’s ability to do that.”
Hahn must balance all that while leading the FDA’s response to the Wuhan crisis, which has heightened some lawmakers’ concern about U.S. reliance on Chinese drug manufacturing after incidents of contamination with carcinogens.
“We have to be concerned about the supply chain to make sure that we have enough of what we need if there are any potential outbreaks here,” Rep. Susan Brooks (R-Ind.) said after a closed-door briefing Thursday for Energy and Commerce committee members with top health officials. The fact that China manufactures much of the protective medical gear used in U.S. hospitals and clinics “should cause us to be reexamining what we’re doing in China versus what should be brought back to this country.” she said.
Outside of the coronavirus, a host of thorny regulatory issues await Hahn. Industry and lawmakers have pressed for a clear FDA framework on selling cannabidiol, the popular hemp and marijuana byproduct decriminalized by the 2018 farm bill — and since sold as medicine, dietary supplements and infused in food, cosmetics and skincare products.
“You cannot walk down the street without seeing the products” but there is a dearth of solid data on how safe and effective CBD actually is, said Hahn.
Those CBD challenges have fueled larger discussions about how to better regulate the vast dietary supplement market, where manufacturers often push legal boundaries by making unverified claims about how herbal or homeopathic products can help people.
“It will be something else next,” said Hahn. We don’t want to overstep our bounds but we want to make sure that safe and effective products are in the hands of people.”