The FDA plans to accelerate some drug reviews

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Food and medication administration proposed a dramatic expansion of its power to accelerate drug reviews.

The agency on Tuesday announced a new national priority coupons plan that aims to reduce drug review times to two months for companies that say they are supporting “national interests of the United States.”

Currently, the FDA has a deadline of 10 months after a company presents a drug application to make an approval decision. This review period is shortened at six months if a company has been awarded a priority review.

“The ultimate goal is to bring more priests and significant treatments to the American public,” said FDA Commissioner Marty Makary, in a statement. The new coupon program is different from the existing efforts of the FDA to accelerate the review processes.

The plan is designed for companies to present “the participation of the lion” of a drug application to the agency even before they have final results of a fundamental clinical trial, a process that according to Makary would reduce inefficiencies.

The FDA can also grant accelerated approval to the products in the new coupon program, which will include “improved” communication with companies while its application is under review. The agency said it can extend the review period if the application is particularly complex or if there is not enough information to support it.

In the first year of the program, the FDA plans to give a limited number of coupons to companies aligned with what it called “national health priorities.” That includes addressing a health crisis in the United States, delivering “more innovative priests” to Americans, addressing not satisfied public health and “increasing the manufacture of national medicines as a national security problem.”

The criteria occur when the Trump administration encourages the pharmaceutical industry to redo the manufacture of medications through executive orders and possible tariffs on imported medications to the United States

In a note on Tuesday, Jefferies analyst Michael Yee said the criteria are broad but that they seem to be positive for the pharmaceutical industry. The program could be more effective than tariffs to encourage drug manufacturers to take their manufacture to the United States.

But questions remain about the risks of accelerating drug reviews at just 30 days, the faster the FDA has done. Another potential concern is whether the coupons will be offered to the political allies of the Trump administration, which could include companies that the FDA staff would normally analyze.

We will look for more information about the new plan, so be attentive.

Do not hesitate to send any advice, suggestion, stories ideas and data to Annika in [email protected].

The Headspace Virtual Mental Health Startup announced a new consumer direct therapy service this week called Headspace therapy.

It is a new territory for the company, which has spent the last decade selling its product to employers and health plans. The new service is available for more than 90 million Americans through the 45 associations in the Headspace network with insurers, including UnitedHealthcare, CIGNA and Blue Cross Blue Shield.

“The head space can now be your mental health partner, being there for everyday life, whether you need help with sleep, stress, anxiety or need access to a therapist,” Headspace CEO, Tom Pichett, to CNBC in New York City on Wednesday, said. “We have everything, and we have it in a supported way by insurance, so that hopefully we can make this really economical for you.”

Pickett, who assumed the executive director role in August, said that the new Headspace Service therapy is part of his vision to complete the company's consumer offers.

Space users' therapy can access individual 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 offer, you have the option to pay $ 149 per session of your pocket. Headspace said he plans to add more partners on the network over time.

Users will also have three months of access to sleep, meditation and stress exercises in the Headspace application, as well as EBB, an artificial intelligence chatbot that can talk and direct people to the best available content. Over time, EBB will also help generate personalized attention plans for each member, Headspace said.

“We have not been completely serving the audience we have, so launching consumers made a lot of sense,” said Picktt.

Headspace, founded in 2010, has raised a total of more than $ 350 million investors such as Khosla Ventures, Kaiser Permanent Ventures and Cigna Ventures, according to Pitchbook.

Picktt said Headspace is “working neutral” and in “a very healthy economic position at this time.” In the short term, the company does not seek to raise more capital and, on the other hand, focuses on building its offers and establishing new associations.

“The ultimate goal is really to become the 'easy button' in mental health,” Picktt said.

Do not hesitate to send any advice, suggestion, stories ideas and data to Ashley at [email protected].