Press Release

Statement on Flawed British Medical Journal Analysis

PhRMA August 9, 2012

Washington, D.C. (August 9, 2012) — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Matthew Bennett issued the following statement today on the recent analysis in the British Medical Journal:

“A new analysis in the British Medical Journal is not only flawed, it provides a misleading picture of the regulatory challenges that impact biopharmaceutical innovation. The reality is that the U.S. is starting to lag behind other countries when it comes to pro-innovation policies and programs that help spur research and development (R&D) and ensure patient access to life-enhancing medicines, according to a recent report by Battelle. However, the recent passage of the bipartisan Prescription Drug User Fee Act, which will help bring safe, effective, and innovative medicines to patients in a timely manner, is a step in the right direction.

“Simply put, the medicines our companies develop provide tremendous therapeutic benefits to millions of patients around the world.  The Congressional Budget Office has stated that, ‘Many examples exist of major therapeutic gains achieved by the industry in recent years…[A]necdotal and statistical evidence suggests that the rapid increases that have been observed in drug-related R&D spending have been accompanied by major therapeutic gains in available drug treatments.’

“To illustrate this point, last year alone, the Food and Drug Administration approved 35 new molecular entities – the highest amount of approvals over the last decade – including 11 new medicines for patients with rare diseases and Hepatitis C who previously had few or no treatment options.  And earlier this year, the first treatment of its kind was approved for patients suffering from cystic fibrosis, a debilitating disease that affects about 30,000 children and adults in the U.S.  It is unfortunate that the authors of the paper overlooked these incredible advancements.

“The more than 3,000 medicines in the pipeline – many of which are potential novel treatments – provide hope to patients with Alzheimer’s, Parkinson’s disease, cancer and other life-threatening conditions.  Biopharmaceutical research companies remain committed to moving the science forward and building on the progress that has already been made against some of the most devastating diseases worldwide, despite the enormous odds companies continue to face in the long and arduous drug discovery process.

“Contrary to the authors’ assertion regarding the source of R&D funding, PhRMA member companies alone invested $49.5 billion in 2011 researching and discovering new medicines.  In fact, more than 21 percent of all biopharmaceutical company domestic sales are dedicated to research and development – the largest percentage dedicated to R&Dof any industry in the U.S.  In fact, between 2000 to 2008, the biopharmaceutical industry was about five times more R&D intensive – annual average R&D as percentage of sales – than all other industries in the U.S., according to the National Science Foundation. This innovation supports four million high-quality domestic jobs and enhances millions of patients’ lives.

“Ultimately, to help ensure that the U.S. remains the world leader in medical innovation, a consistent pro-innovation policy framework must be in place that provides regulatory certainty, ensures patient choice and access to medicines and incentivizes future research and development.”

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 $49.5 billion in 2011 in discovering and developing new medicines.

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