The road to discovering a life-saving treatment or medicine is long and filled with obstacles. “For those with life-threatening diseases or painful chronic conditions, time is not on their side. When promising treatments languish waiting for approval in a bog of bureaucracy, the cost must be reckoned in lost lives and diminished quality of life.”
“That’s why it’s so alarming that only 21 new drugs gained FDA approval last year.”
As a recent article noted, this “was a significant decrease from the previous two years, when there were 25 approvals in 2009 and 24 in 2008.”
The article, written by Robert Goldberg, co-founder and vice president of the Center for Medicine in the Public Interest in New York, also recognized that “not only are approvals down, so are applications for approval.” He predicted that this will mean “even further declines in annual approvals down the road.”
But what is so perplexing about the decline in drug approvals is that “science is more cutting edge today and grants for new research — in areas from pediatrics to Alzheimer’s — are at all-time highs.” So then, “how is it possible that approvals and applications are both dropping?”
Goldberg noted that one reason is that “the FDA’s review process, in the view of many in the medical and biopharmaceutical communities, has become increasingly turgid.” For example, he noted how “the FDA now frequently calls for extra clinical trials, requiring detailed safety plans that necessitate additional doctor and patient education, and an extended review period.”
He also noted that, “of the 21 drugs approved in 2010, there were 21 drug makers to take credit. Not a single company earned more than one approval. From Pfizer to Bristol-Myers Squibb to Eli Lilly to Merck — all of which were shut-out for approvals in 2010 — the FDA was an equal opportunity rejecter.”
Unfortunately, Goldberg also noted that the small amount of approvals also takes place in the “development of tools that tailor treatments to our individual needs are drowning in a sea of endless confusion.” He asserted that “tests and medical efforts that can help detect and prevent disease, and eliminate useless or even harmful care are being held up in the name of patient safety.”
Consequently, Goldberg recognized that “government policy writ large has now begun to stifle innovation in pharmaceuticals.” For example, he pointed out how “Obama’s health care plan levies tens of billions in taxes on new medical products through 2019.”
In addition, he acknowledged how “comparative effectiveness studies, required even after FDA approval as a condition for being added to benefits, will delay progress, too.” Even worse, he noted, is that “FDA regulators are beginning to consider the comparative effectiveness of products and as a result are raising the bar for approval.”
Ultimately, Goldberg asserted that “innovation is the result, not of a top-down decision, but by learning from actually using an invention,” and “taking products off the market therefore undermines medical progress in many cases.” Accordingly, Goldberg noted that, “innovation is in a very precarious position” because of the “the FDA’s slow-to-act review process and the Obama health care plan’s disproportionate taxation of pharmaceutical firms.”
The reality is, “most medical innovations come from start-ups with limited capital,” and by FDA and the Obama administration making it harder for these small business, the government is doing the opposite of advancing science and medicine. This regulatory uncertainty has left many asking, “whether developers can bring enough new drugs to market at the pace needed to remain financially viable.”
This is problematic because as Goldberg points, out, “China, India and Singapore are inviting America’s innovators to set up shop overseas.”
Therefore, Goldberg asserted that, “as the world’s leader — by far — in scientific research investment, the United States must change course and must do so immediately” because “not only are we losing innovation, we are losing lives as well.”
Before too many people gasp at the thought that (OMG!) the FDA could have the gall to ask for safety information:
"Goldberg noted....how “the FDA now frequently calls for extra clinical trials, requiring detailed safety plans that necessitate additional doctor and patient education, and an extended review period.”
You might want to check out the source of the comment.
http://thinkprogress.org/2009/11/18/cmpi-front-group/
Posted by: Sheila Fields | March 22, 2011 at 11:42 AM