WASHINGTON, March 12 /PRNewswire-FirstCall/ -- Proposed legislation that creates a regulatory framework to guide the approval of the first biogeneric medicines represents a critical step forward in providing more affordable treatment for millions of Americans suffering from chronic and complex conditions, David B. Snow Jr., chairman and CEO of Medco Health Solutions, Inc. (NYSE: MHS) said today.
"The investment in research and innovation over a period of many years has led to the breakthrough therapies that are available today in specialty pharmacy for the treatment of many serious diseases," said Snow. "We salute the vision of Chairman Waxman, Representative Deal and their co-sponsors, who have crafted an approach that balances the government's role for promulgating and regulating, while allowing the private sector to innovate and operate. This framework authorizes the FDA to construct an approval process that can lead to lower costs for payors and patients, while continuing to incent and reward breakthrough science."
Currently, as much as 16 percent of overall spending on so-called "specialty" medicines goes toward purchasing biotech drugs that have already lost their patent protection but, without this critical approval process, have no lower-cost generic competition. Medco estimates that generic versions of biotech medicines -- often called "biosimilars"-- could reach the market by 2013, creating a $34 billion opportunity in this new market through 2017, and significantly lowering the costs for these medicines.
"This legislation provides the FDA with the authority to ensure that we remain the world's gold standard for prescription drug safety, and extends it to a generics approval process for a new class of medicines," said Snow. "For all their therapeutic benefit, patients and payors alike are overwhelmed by the financial burden of paying for these expensive medicines. This proposal embodies the spirit of healthcare reform that is advocated by the administration and bi-partisan congressional leaders - reform that will result in delivering better, more affordable, care to more Americans."
The "Promoting Innovation and Access to Life-Saving Medicine Act," was introduced by House Energy and Commerce Committee Chairman Henry Waxman (D-Calif.), and Reps. Nathan Deal (R-Ga.), Frank Pallone (D-N.J.), and Jo Ann Emerson (R-Mo.). It would authorize the FDA to use its experience and expertise to use an approval pathway that will ensure the safety and efficacy of biogenerics.
Medco Health Solutions, Inc. (NYSE: MHS) is a leading health care company, serving the needs of more than 60 million people. Medco, the world's most advanced pharmacy(R), provides clinically driven pharmacy services designed to improve the quality of care and lower total health care costs for private and public employers, health plans, labor unions and government agencies of all sizes, and for individuals served by Medicare Part D Prescription Drug Plans. Through its unique Medco Therapeutic Resource Centers(R) and the Accredo Health Group, Medco's specialty pharmacy, the company is creating innovative models for the care of patients with chronic and complex conditions. Medco is a leader in the emerging field of personalized medicine and in applying evidence-based protocols to elevate the practice of pharmacy, a key element in reforming America's health care system. Medco is ranked number 51 on the Fortune 500 list, with 2008 revenues of more than $51 billion. For more information about Medco, go to http://www.medcohealth.com.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that may cause results to differ materially from those set forth in the statements. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Forward-looking statements are not historical facts, but rather are based on current expectations, estimates, assumptions and projections about the business and future financial results of the pharmacy benefit management and specialty pharmacy industries, and other legal, regulatory and economic developments. We use words such as "anticipates," "believes," "plans," "expects," "projects," "future," "intends," "may," "will," "should," "could," "estimates," "predicts," "potential," "continue," "guidance" and similar expressions to identify these forward-looking statements. Medco's actual results could differ materially from the results contemplated by these forward-looking statements due to a number of factors, including those set forth below.
|SOURCE Medco Health Solutions, Inc.|
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