US Stem Cell Inc (USRM)

[Havoc23]

https://www.google.com/amp/reason.com/blog/2017/03/13/scott-gottlieb-trumps-nominee-for-food-a/amp

Gottlieb, who has been associated with venture capital side of medical innovation, will seek to change the agency's culture from the current highly precautionary approach to one that more readily recognizes that benefits always come with risks. Under his direction, the agency would likely exercise a lighter regulatory hand over the development of new medical apps and diagnostics while seeking to work out the best way to speed up the approval of novel therapeutics based on stem cells and gene-edting technologies like CRISPR.

Mr Gottlieb will certainly wish to find more ways of speeding drug approvals.The agency has done much on this front already. Yet inconsistency continues: some divisions of the FDA respond to routine inquiries from companies in a few weeks; others take three months. Mr Gottlieb has also criticised the agency for having a culture that values “excessive desire for certainty”. Attempts to change this will elicit criticism that patient safety is in jeopardy. Yet in some cases it is clear that the demand for ever-larger clinical trials of new drugs has done little for safety, raised costs and rewarded chiefly the very largest companies that can afford to run them.

One path will be to advance the trend for gathering evidence from trials that take place in the real world, not under tightly controlled conditions. GlaxoSmithKline, a British pharmaceutical group, recently completed the world’s first such test for a drug, Relvar, which treats asthma and chronic obstructive pulmonary disease. The four-year trial was conducted by monitoring thousands of patients’ electronic medical records.

Generic drugs is another area where Mr Gottlieb has signalled his views. In a commentary for the Wall Street Journal in August, he criticised the policymaking that had kept some generic medicines off the market, raising prices. He may want to tackle the rising cost and complexity of filing applications to market generic drugs—the problem that allowed Martin Shkreli, a controversial entrepreneur, to raise the price of Daraprim, an anti-parasitic drug, by 5,000% in 2015, causing fury.
The FDA also needs to run faster to keep abreast of innovation. Sudip Parikh, a policy adviser at the Drug Information Association, another think-tank, says the rate of change means that decades-old rules and regulations may not function well for new treatments. Some rules will be too restrictive, others too permissive. On the one hand, for example, more should be done to allow digital health-care products to escape the grasp of the FDA; on the other, the use of stem cells should face more scrutiny. Many clinics offer unregulated stem-cell treatments because of a loophole in the law. Three people were recently found to have been blinded by such treatments.