How outrageous is this?

barbara

Pioneer Founding member
Good for who? Not good for patients who only want the right to access their own stem cells. Under Hamburg, our stem cells are now regulated as drugs. I am truly offended when I read articles like this. Of course, someone like Rachel King is going to support her. Words can't begin to express how I feel about the abuse of power going on with the FDA. They literally control whether we live or die. They sleep with Big Pharma and the BioTech industry in a plushy King sized bed. We get to sleep on the bare floor without a blanket begging for our lives.


Stability at head of FDA good for biotech, says GlycoMimetics CEO
Washington Business Journal by Bill Flook, Staff Reporter
Date: Wednesday, November 7, 2012


http://r.smartbrief.com/resp/dZeHBWlUxbCfbyedCidmozCicNCVqE?format=standard

Margaret Hamburg will, presumably, remain chief of the Food and Drug Administration into a second Obama term. And that’s good for the biotech industry, said Rachel King, CEO of Gaithersburg-based GlycoMimetics Inc. and a board member of her industry’s trade group, BIO.
“The consistency is positive,” said King, for an industry that relies on predictability within its chief regulator.

Hamburg has spent much of her time as commissioner attempting to patch relations between the FDA and drug industry, and King is among those who are upbeat about her tenure. The agency has recently “approved some real breakthrough drugs much faster than expected,” like Pfizer’s lung cancer treatment Xalkori and Vertex Pharmaceuticals’ cystic fibrosis drug Kalydeco.
The pharma and biotech industry and FDA recently renegotiated the Prescription Drug User Fee Act, or PDUFA, a industry fee vehicle that funds the review and approval of new drugs. King credits Hamburg’s agency with negotiating several important provisions within the latest version of PDUFA: the expansion of an accelerated approval pathway, enhanced communication between the FDA and drug-developers, and the new designation of “breakthrough therapies.”

“The FDA under her watch was involved in negotiating those provisions, and I think it’s positive that she’s going to continue to be in place to see their implementation,” King said.

King sits on the executive committee of the D.C.-based Biotechnology Industry Organization, or BIO, which is chaired by former Human Genome Sciences Inc. CEO Tom Watkins.

Separate from Hamburg, King is happy to see the likely survival of the Affordable Care Act, or Obamacare, which set a regulatory pathway for biosimilars, or generic versions of biologic drugs.

“We’ve had some time now to get used to thinking about what those provisions are going to be,” she said. “If we had the reasonable expectation that a lot of things would be up for grabs again, I think that would throw some uncertainty into the industry’s consideration for a number of issues, biosimilars for example.”

Bill Flook covers technology, biotech and venture capital.
 
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