Tag: Emergent BioSolutions Inc

Life expectancy in the U.S. is between three and five years lower than the average in other high-income countries — and the gap comes in part from misinformation, Food and Drug Administration Commissioner Dr. Robert Califf said.

“It’s looking worse, not better, over the last several years,” Califf told CNBC in an interview Thursday at the agency’s headquarters in Silver Spring, Maryland.

It’s not just the Covid pandemic contributing to the decline, he said, pointing out the gap with peer nations is widening. Califf said a new factor has joined the list of known causes of life-expectancy disparities like race, ethnicity, income and education: living in a rural area, where he noted that people are exposed to different information sources.

“Why aren’t we using medical products as effectively and efficiently as our peer countries? A lot of it has to do with choices that people make because of the things that influenced their thinking,” Califf said.

The commissioner is just more than a year into his second turn at the top of the agency, one of only two top leaders of the FDA to return to the job for a separate second term. Since he left in January 2017, at the end of the Obama administration, the pandemic and rising political tensions have made combatting misinformation even more complicated — and led Califf to make it one of his top priorities at the agency.

“You think about the impact of a single person reaching a billion people on the internet all over the world, we just weren’t prepared for that,” Califf said. “We don’t have societal rules that are adjudicating it quite right, and I think it’s impacting our health in very detrimental ways.”

He said there’s a need for better regulation, including “specific authorities at FDA, FTC and other areas” to root out misinformation.

Califf spoke to CNBC a day before a federal judge suspended the FDA’s approval of abortion pill mifepristone, a decision that could have broad implications both for abortion access and regulation of future drugs. The FDA commissioner spoke about multiple topics including efforts to cut drug prices, a priority for the Biden administration and lawmakers from both parties in Congress.

Califf noted that while the FDA doesn’t play a direct role in pricing medicines, it has tools to influence drug costs.

“We have an indirect role, and we have a bully pulpit to make the public aware and put some pressure on,” he said, noting that he has previously said drug prices are set by “what you can get minus the shame factor.”

Califf recently wielded some of that power after the agency approved the first over-the-counter version of Narcan, the opioid overdose reversal drug. He tweeted that the FDA encouraged the manufacturer, Emergent BioSolutions, to make the drug available “as soon as possible and at an affordable price.”

He plans to use that bully pulpit in a bigger way to rein in drugmakers on pricing — while trying to walk a fine line with checking a pharmaceutical industry that he noted produces life-saving products from vaccines to statins.

“There’s a balance here that we have to reach,” he said. “And in some areas we’re not in the right balance right now.”

Califf is also encouraging the drug industry to consider investments in neglected areas of research. He spoke with CNBC the day the agency withdrew approval of the only available drug for preterm birth, Makena, after a confirmatory trial didn’t verify its clinical benefit.

“The data were quite clear,” he said. “But we should be reminded that we’re seeing an explosion of maternal mortality in this country and a lot of premature delivery leading to prolonged illness and neonatal intensive care unit stays for infants.”

“We need effective treatments,” Califf said. “And the industry is not producing much in the way of effective treatment.”

He also pointed to tobacco cessation products and non-addictive medicines for chronic pain as areas “where the industry is not really producing.”

Incentives put in place by the FDA and others in areas like cancer and rare diseases have revolutionized drug development for those conditions, and similar efforts could help in the development of other treatments, Califf said.

“Now we’ve got to go back to these other areas and figure out what to do to stimulate activity,” he said.

On the opposite end of the spectrum for drug industry interest are new medicines for obesity and diabetes, like those from Novo Nordisk and Eli Lilly: Ozempic, Wegovy and Mounjaro.

Califf, a cardiologist, said he has “great hope for this class of drugs,” noting it’s one of a growing number of classes of medicines “that are dealing with the axis between our gut and our brain.”

“A lot of the things that we thought were willpower before, we’re now coming to understand that our bellies are signaling our brain and vice versa, through endocrine pathways,” he said.

He noted he’s looking forward to results from studies known as outcomes trials looking at whether the medicines lower the risk of heart disease and stroke when used by people who are obese but don’t have diabetes.

“If that pans out, we’ll have some major decisions to make as a society,” Califf said. “When do we add the drugs to the advice that we’re giving to people in the general population?”

Results from Novo Nordisk’s outcomes trial for Wegovy are expected this summer. Questions may remain about the longer-term safety of taking these medicines: Novo Nordisk’s executives have noted patients must keep taking the drugs to sustain weight loss.

Califf said the U.S. could improve its data collection systems using electronic health records to track things like the long-term safety of these drugs.

“If you want to know if a safety signal is going to pop up, we should be able to assay the composite of electronic health records of people on the treatment and not on the treatment, and we should be able to do long-term, randomized clinical trials at a very low cost,” Califf said. “We haven’t developed that system in the U.S.; the UK and Israel are way ahead of us in that regard and we need to catch up.”

Califf also noted it’s possible the drugs will prove to be safer than hoped. He cited statins — for high cholesterol — and drugs for high blood pressure. He said the profile of those medicines “looks better and better over time.”

He also took issue with the idea that patients must take the new obesity medicines indefinitely to keep weight off.

“It’s true if you stopped the drug after some period of time the weight would come back up, but I’m not sure these people have gotten the behavioral interventions,” Califf said.

He pointed to other areas of medicine where “people feel like they just can’t succeed,” like smoking cessation, where a medicine in addition to clinical care means “it may not be the case that it’s totally an irreversible situation where you’re just going to bounce right back.”

As use of the medicines has exploded, leading to jokes about Ozempic at the Oscars and on Saturday Night Live, Califf said it’s not the FDA’s place to opine on off-label use of medicines.

“We can’t interfere with the practice of medicine, and we won’t do that,” he said. “We need to make our communications clear about where the evidence exists for where the benefits outweigh the risks.”

But one word of caution Califf did issue was on use of compounded versions of the weight loss drugs provided online by unauthorized suppliers.

“Compounding is highly regulated,” Califf said. “It should only be used in specific circumstances. Fraud use for weight loss is not one of those.”

— CNBC’s Leanne Miller contributed to this report