The 21st Century Cures Act is up for a vote in the House today. Among other things, the bill would speed up the drug and device approval process at the FDA by pushing different evidence standards. Could be very good for the stem-cell industry.
Alliance for Regenerative Medicine lobbied for this and has issued a press release:
The Alliance for Regenerative Medicine Commends Passage of 21st Century Cures Act, Inclusion of Regenerative Medicine-Specific Provisions
WASHINGTON, D.C., December 1, 2016 – The Alliance for Regenerative Medicine (ARM), the international advocacy organization representing the gene and cellular therapies and broader regenerative medicine sector, commends the U.S. House of Representatives’ bipartisan passage of the 21st Century Cures Act.
ARM is particularly pleased the bill includes regenerative medicine-specific provisions intended to optimize the U.S. Food and Drug Administration’s (FDA) approval pathways for regenerative medicine products, without reducing the agency’s high approval standards for product safety and efficacy.
“This legislation maintains the FDA’s appropriately high product approval standards, while providing for the flexibility to consider the unique attributes of these innovative products,” said Michael Werner, executive director, ARM.
ARM has previously expressed concerns about proposals that sought to change approval pathways for regenerative medicine products by reducing, or in some cases, eliminating the FDA’s regulatory authority, which could have allowed untested and unproven treatments to reach the market. ARM is pleased this proposal supports product development by optimizing FDA’s regulatory pathway without reducing the Agency’s authority.
The bill introduces, for the first time in the U.S., a specific Regenerative Medicine / Advanced Therapy (RMAT) Product designation. This specific acknowledgement of the importance of these technologies provides regenerative medicine and advanced therapy product sponsors with key benefits, including:
Guaranteed interactions with the FDA
Eligibility for priority review and accelerated approval
Flexibility in the number of clinical sites used and the possibility to use patient registry data and other sources of “real-world” evidence for post-approval studies, pending agreement and approval from FDA
The bill also requires the FDA to work with sector stakeholders to identify ways to develop standards that aid in product development and evaluation, which ARM has asserted is essential to commercialization efforts and sector advancement.
With last night’s passage in the House, the bill now moves to the U.S. Senate for vote next week.
The Senate should be voting on this bill later today. Passage seems almost guaranteed, and after reconciliation Obama will sign into law sometime this month.
Overall I view this as a very questionable handout to big pharma. I think it is naive to conclude that the FDA will change their decades long bias towards the big boys, so I would predict that the main "benefits" of this law will go to the big companies drug and device candidates.
But on the bright side at least our poor beat up stock should look slightly more favorable to the broader market, if the overall regulatory environment is more friendly. Cytori should have very robust data coming for Scleroderma, but perhaps this law could benefit us down the road for other indications (if Cytori is still in business then). As we know, management likes to change indications every two years and pretend that the previous focus of the company never happened.
1. I do not think WST has any CYTX shares. He is a "paid" online financial columnist: based on his most recent postings here and there, he is on other people's favorite list, but not on CYTX's. CYTX should find someone else to do its PRs - Tiago Girao cannot do the job well (he is a great book keeper, but poor in communication).
2. Regardless, where the stem cells may come from, one year before CYTX's departure from expensive cardio clinical trials, there was a very thorough summary article on British Medical Journal indicating lack of medical evidence (per current medical standards and US/EU FDA guidelines) for efficacy. Just look at TEVA - MESO decision on MESO's cardio trials: TEVA dropped out of the partnership, in the middle of a large cardio clinical trial. It is very hard for a big pharma to support this kind of trials. I personally think the stroke indication will be in the same boat. Big pharmas are not use to studies in which the clinical efficacy results would be evident several years down the road. Stem cells work very slow - it is the body own regenerative properties at work.
CYTX's celution system is looking for its uses. If it would effective in scleroderma and wound healing (reference OSIR), as well as in plastic surgery we are in luck.
3. By the way, your presence here is great - your daily trading reporting is great.
The following user(s) said Thank You: rodney.strongg