The FDA plans to accelerate some drug ratings
FileToto: The headquarters of the US Food and Drug Administration (FDA) can be seen in Silver Spring, Maryland, November 4, 2009.
Jason Reed | Reuters
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The Food and Drug Administration proposed a dramatic extension of its power to accelerate drug tests.
The agency announced a new National Priority voucher plan on Tuesday that aims to reduce drugs from the drugs to one to two months for companies that they say, they support “national US interests”.
The FDA currently has a period of 10 months after a company submitted a drug application to make an approval decision. This review period is reduced to six months if a company has been given a priority review.
“The ultimate goal is to bring the American public more remedies and sensible treatments,” said the FDA Commissioner Marty Makary in a press release. The new voucher program differs from the existing efforts of the FDA to speed up review processes.
The plan is intended to present the company “the lion's share” of a drug application to the agency, even before they achieve final results from a crucial clinical study, a process that Makary said would reduce inefficiencies.
The FDA can also provide an accelerated approval for products in the new voucher program, which includes the “expanded” communication with companies during the review. The agency said it could extend the review period if the application is particularly complex or if there is not enough information to support support.
In the first year of the program, the FDA is planning to give companies a limited number of vouchers with the so -called “national health priorities”. This includes combating a health crisis in the United States, providing “more innovative healing” for Americans, fighting public health and increasing domestic purposes as a national security problem “.
The criteria are carried out as the Trump administration encourages the pharmaceutical industry to form the production of drugs through executive commands and potential tariffs for medication imported into the USA
In a note on Tuesday, Jefferie's analyst Michael Yee said that the criteria were wide, but seem to be positive for the pharmaceutical industry. The program could be more effective than tariffs to encourage drug manufacturers to bring their production to the USA
However, there are questions about the risks of accelerating drug reviews to just 30 days – the fastest of the FDA. Another potential concern is whether the vouchers of political allies of the Trump management are offered, which could include companies that the FDA would normally examine.
We will search for further information about the new plan. So stay up to date.
Feel free to send Annikakim.constantino@nbcuni.com tips, suggestions, ideas and data to Annika.
The latest in Health-Care Tech: Headspace starts direct offer for consumers and unlock fresh sources of income
The virtual psychical health startup headspace announced this week a new therapy service for direct consumers entitled Therapy by Headspace.
It is a new territory for the company that has spent the past decade to sell its product to employers and health plans. The new service is available more than 90 million Americans via the 45 HeadSpace in-net work partnerships with insurers, including the 45 in-network partnerships UnitedhealthcarePresent Cigna and Blue Cross Blue Shield.
“Headspace can now be your companion of mental health, be there for everyday life, whether you need help with sleep, stress, fear or access to a therapist,” Tom Pickett, CEO of Headspace, told CNBC in New York City on Wednesday. “We have everything and we have it in an insurance insured way so that hopefully we can make it really cost -effective for you.”
Pickett, who took on the role of the managing director in August, said that the new therapy of the headspace service was part of his vision to round off the company's consumer offers.
The therapy by headspace users can access video sessions with licensed therapists on video sessions, and most of the covered members pay between $ 0 and $ 35 per session. If a user's insurance does not cover the offer, you have the option of paying 149 US dollars per session out of your own pocket. Headspace said it is planning to add more in-network partners over time.
Users also have three months access to sleep, meditation and stress exercises in the HeadSpace app and EBB, a chat bot for artificial intelligence that can maintain and guide people to the best available content. Over time, EBB will also help to create personalized care plans for each member, said Headspace.
“We did not fully serve the audience we have, and the therapy for consumers made a lot of sense,” said Pickett.
According to PitchBook, the headspace, founded in 2010, has collected a total of more than 350 million US dollars by investors such as Khosla Ventures, Emperor Permanent Ventures and Cigna Ventures.
Pickett said that headspace was “neutral” and in “a very healthy economic position” at the moment. In the short term, the company no longer wants to attach capital and instead focuses on building its offers and hiding new partnerships.
“The ultimate goal is really to become a 'simple button' in mental health,” said Pickett.
Feel free to send tips, suggestions, story ideas and data to Ashley at Ashley.capoot@nbcuni.com.
