Drugmaker’s Guide to the 21st Century Cures Act Changing the Face of Pharmaceutical and Biologics Regulation
The newly passed 21st Century Cares Act doesn’t just force an adjustment of the FDA’s policies. It calls for a sea of change in the waters you have learned to navigate so well. Attached to the 2016 “Tsunami Warning Bill” to guarantee passage, the act will bring a tidal wave of new regulations you will have to learn to accommodate.
The act moves away from the traditional, lengthy and costly clinical trial model in favor of more “real-world” evidence from observational studies, patient registry reviews, etc. That’s bad news for clinical research organizations as well as university and hospital IRBs. And it could be bad news for patients if less-rigorously researched drugs reach the market and turn out to have unforeseen effects.
Drugmakers, on the other hand, will benefit from the relaxing of premarket requirements, especially since the act now allows them to promote off-label uses to insurance providers without going through the FDA’s approval process for new indications.
The act aims to loosen the FDA’s reigns, but in such vague terms that FDA/industry lawsuits are not only likely, they’re almost inevitable. And Congress didn’t set aside money specifically to carry out the act’s provisions, which means it will carve into the FDA’s regular budget — to the tune of $20 million in 2017 — and cause underfunding of some of the agency’s other priorities.
If you want to survive the coming storm — you need to start preparing now.
The Drugmaker’s Guide to the 21st Century Cures Act e-book tells you what to expect in the coming months, which new provisions are likely to cause trouble and how to get out in front of the changes. You will learn about how:
The FDA will be forced to accept “consistent, parallel scientific advice” from clinical trials outside their jurisdiction (i.e., non-US research)
The FDA will no longer conduct quality inspections of manufacturers of excipients
Sponsors of investigational drugs will have to create a policy for evaluating and responding to requests for expanded access to the drugs
Universities’ and hospitals’ local IRBs will be locked out of most trials
Vague terms like “in the best interest of patients” and “probable benefit” leave holes you could drive a truckload of lawyers through
Order your copy of Drugmaker’s Guide to the 21st Century Cures Act and keep up on the wave of changes in pharmaceutical and biologics regulations.
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