FILE PHOTO: The headquarters of the U.S. Food and Drug Administration (FDA) is seen in Silver Spring, Maryland November 4, 2009.
Jason Reed | Reuters
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The Food and Drug Administration proposed a dramatic expansion of its power to speed up drug reviews.
The agency on Tuesday announced a new national priority voucher plan that aims to cut drug review times to one-to-two months for companies it says are supporting “U.S. national interests.”
Currently, the FDA has a deadline of 10 months after a company files a drug application to make an approval decision. That review period is shortened to six months if a company has been granted a priority review.
“The ultimate goal is to bring more cures and meaningful treatments to the American public,” FDA Commissioner Marty Makary said in a release. The new voucher program is different from the FDA’s existing efforts to speed up review processes.
The plan is designed for companies to submit “the lion’s share” of a drug application to the agency even before they have final results from a pivotal clinical trial, a process that Makary said would reduce inefficiencies.
The FDA may also grant an accelerated approval to products in the new voucher program, which will include “enhanced” communication with companies while their application is under review. The agency said it may extend the review period if the application is particularly complex or if there is insufficient information to support it.
In the first year of the program, the FDA plans to give a limited number of vouchers to companies aligned with what it called “national health priorities.” That includes addressing a health crisis in the U.S., delivering “more innovative cures” to Americans, addressing unmet public health needs and “increasing domestic drug manufacturing as a national security issue.”
The criteria come as the Trump administration encourages the pharmaceutical industry to reshore drug manufacturing through executive orders and potential tariffs on medicines imported into the U.S.
In a note on Tuesday, Jefferies analyst Michael Yee said the criteria are broad but appear to be positive for the pharmaceutical industry. The program could be more effective than tariffs at encouraging drugmakers to bring their manufacturing to the U.S.
But questions remain about the risks of speeding up drug reviews to as little as 30 days – the fastest the FDA has ever done. Another potential concern is whether the vouchers will be offered to political allies of the Trump administration, which could include companies that the FDA staff would normally scrutinize.
We’ll be looking out for more information on the new plan, so stay tuned.
Feel free to send any tips, suggestions, story ideas and data to Annika at [email protected].
Latest in health-care tech: Headspace launches direct-to-consumer offering, unlocking fresh revenue stream
Virtual mental health startup Headspace announced a new direct-to-consumer therapy service this week called Therapy by Headspace.
It’s new territory for the company, which has spent the last decade selling its product to employers and health plans. The new service is available to more than 90 million Americans through Headspace’s 45 in-network partnerships with insurers, including UnitedHealthcare, Cigna and Blue Cross Blue Shield.
“Headspace now can be your mental health companion, be there for the everyday, whether you need help with sleep, stress, anxiety or you need access to a therapist,” Headspace CEO Tom Pickett told CNBC in New York City on Wednesday. “We’ve got it all, and we’ve got it in an insurance-backed way, so that we can hopefully make this really inexpensive for you.”
Pickett, who took on the chief executive role in August, said the new Therapy by Headspace service is part of his vision to round out the company’s consumer offerings.
Therapy by Headspace users can access one-on-one video sessions with licensed therapists, and most covered members will pay between $0 and $35 per session. If a user’s insurance does not cover the offering, they have the option to pay $149 per session out of pocket. Headspace said it plans to add more in-network partners over time.
Users will also get three months of access to the sleep, meditation and stress exercises on the Headspace app, as well as Ebb, an artificial intelligence chatbot that can converse and direct people to the best available content. Over time, Ebb will also help generate personalized care plans for each member, Headspace said.
“We have not been fully serving the audience that we have, and so launching therapy to consumers made a lot of sense,” Pickett said.
Headspace, founded in 2010, has raised a total of more than $350 million from investors like Khosla Ventures, Kaiser Permanente Ventures and Cigna Ventures, according to PitchBook.
Pickett said Headspace is “running neutral” and in “a very healthy economic position right now.” In the near term, the company isn’t looking to raise more capital, and is instead focused on building out its offerings and inking new partnerships.
“The ultimate goal is really to become the ‘Easy Button’ in mental health,” Pickett said.
Feel free to send any tips, suggestions, story ideas and data to Ashley at [email protected].
