Press Releases
PhRMA Statement on the Sentinel Initiative
Washington, D.C. (May 22, 2008) —Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement today on efforts underway at the Food and Drug Administration and Centers for Medicare and Medicaid Services to help improve patient safety and the quality of medical care:
"We agree with Secretary Leavitt: the Food and Drug Administration's new drug safety initiative is vitally important because it allows regulators and health care professionals to move from reliance on voluntary reporting of side effects to proactive monitoring of medicines and other medical products on the market. What's more, today's announcement about the Sentinel Initiative fits in well with PhRMA's thinking. Over the past four years, we have been working with others to improve the way we assess the safety and benefit of medicines that have been approved and are on the market.
"PhRMA also was a strong supporter of last fall's passage of the Food and Drug Administration Amendments Act, which requires the FDA to develop an active risk identification system.
"As noted in a new FDA white paper, the Sentinel Initiative includes development of a new electronic system that will enable agency officials to survey a broad array of data to identify possible side effects. Clearly, this program should improve the efficiency of post-market surveillance of medicines and, in the end, the beneficiaries will be the many patients using these products."
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 $44.5 billion in 2007 in discovering and developing new medicines. Industry-wide research and investment reached a record $58.8 billion in 2007.
PhRMA Internet Address: www.phrma.org
For information on stories of hope and survival, visit: http://sharingmiracles.com/
PhRMA en Español: www.nuestraphrma.org
For information on how innovative medicines save lives, visit: www.innovation.org
For information on the Partnership for Prescription Assistance, visit: www.pparx.org
For information on the danger of imported drugs, visit: www.buysafedrugs.info
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 $44.5 billion in 2007 in discovering and developing new medicines. Industry-wide research and investment reached a record $58.8 billion in 2007.
PhRMA Internet Address: www.phrma.org
For information on stories of hope and survival, visit: http://sharingmiracles.com/
PhRMA en Español: www.nuestraphrma.org
For information on how innovative medicines save lives, visit: www.innovation.org
For information on the Partnership for Prescription Assistance, visit: www.pparx.org
For information on the danger of imported drugs, visit: www.buysafedrugs.info