Washington, D.C. (August 24, 2010) — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President David E. Wheadon issued the following statement today regarding the benefits that new medicines provide to patients and public health:
“The Food and Drug Administration (FDA) has approved more than 300 new medicines in the past decade, helping patients to live longer, healthier and more productive lives.
“New medicines produced by America’s biopharmaceutical research companies have transformed once-deadly cancers into treatable chronic conditions; these treatment advances are credited with helping to increase life expectancy for cancer patients and for lowering death rates. Deaths from heart disease and stroke are falling, and the death rates from heart failure and heart attacks have plummeted by nearly half from 1999 to 2005.
“And new medicines are in development that hold the promise of taming such difficult-to-treat conditions as Alzheimer’s disease, which significantly impacts patients, their families and the growth rate of healthcare costs. For example, recent research has estimated that delaying the onset or slowing the progression of Alzheimer’s disease by five years could lead to significant savings for Medicare and Medicaid.
“‘[R]apid increases that have been observed in drug-related R&D spending have been accompanied by major therapeutic gains in available drug treatments.’ This view – put forth by the non-partisan Congressional Budget Office (CBO) – runs counter to a research paper presented recently at the American Sociological Association’s annual meeting.
“The notion that new medicines are ‘marginally innovative’ is insulting to patients whose lives are being extended or improved by these breakthrough therapies. The paper, ‘Pharmaceuticals: A Two-Tier Market …’ makes a number of other misstatements of fact, among them:
“Disclosing medicines’ risk: The Food, Drug and Cosmetic Act requires that all significant risks be disclosed in medicines’ approved labeling – even if no causal connection has been proven between the medicine and the observed adverse events. These risks are derived from years of clinical testing, typically in thousands of patients, as well as in postmarket experience. To allege a lack of transparency about the risks of medicines is flatly incorrect and not grounded in the reality that the labeling for FDA-approved medical products typically bear dozens of pages of listings of side effects and warnings.
“It’s also important to remember that patients rely on healthcare professionals to explain the pertinent benefits and risks prior to receiving a prescription medicine.
“Investment in R&D v. marketing spending: America’s biopharmaceutical research companies lead the world in discovering and developing medicines that allow patients to live longer, healthier and more productive lives. Our industry invested an estimated $65.3 billion in 2009 in discovering and developing new medicines. That R&D investment by America’s biopharmaceutical research companies is roughly double the overall annual budget for the National Institutes of Health. And, by contrast, the CBO reported that pharmaceutical manufacturers spent an estimated $20.5 billion on promotional activities in 2008.
“‘Low bar’ for regulatory approval: For every 5,000 to 10,000 promising compounds tested, just five medicines will make it to clinical trials involving patients and, of those, only one will eventually receive FDA approval. Our member companies devote an average of 10 years to 15 years on complex research and development and spend up to $1.3 billion on R&D for each new medicine approved. In recent years, clinical trials have become even more complex and more time-consuming, according a Tufts Center for the Study of Drug Development study completed this May.
“FDA approval is, by no means, assured. What’s more, FDA reform legislation has provided the Agency with new authorities that it has begun to exercise and has made outside review of new medicine applications by independent advisory committees a routine occurrence prior to an FDA approval decision.
“For these and other reasons, our initial reading of this research paper finds its arguments seriously flawed.”
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $50.3 billion in 2008 in discovering and developing new medicines. Industry-wide research and investment reached a record $65.2 billion in 2008.
PhRMA Internet Address: www.phrma.org
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