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DewDiligence

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Wednesday, 02/14/2007 12:51:05 PM

Wednesday, February 14, 2007 12:51:05 PM

Post# of 252301
GPhA Endorses Access to Life-Saving Medicine Act

[The name of this congressional bill is histrionic but the bill, which creates a formal regulatory path for generic biologics, is arguably the most consequential healthcare matter before Congress for biotech investors.]

http://biz.yahoo.com/prnews/070214/nyw121.html?.v=84

>>
Wednesday February 14, 12:21 pm ET

Legislation Would Create Safe, Abbreviated FDA Approval Pathway for Biogenerics

ARLINGTON, Va., Feb. 14 /PRNewswire/ -- The Generic Pharmaceutical Association (GPhA) today expressed its strong support for bipartisan legislation to bring safe, effective and affordable biogenerics to consumers. With countless Americans struggling to afford these life-saving medicines, "The Access to Life-Saving Medicine Act" will create a safe, clear and efficient abbreviated Food and Drug Administration (FDA) approval pathway so patients can have timely access to biogenerics. GPhA applauded the legislation's sponsors, U.S. Representatives Henry Waxman (D-CA), Jo Ann Emerson (R-MO), Frank Pallone (D-NJ) and Rahm Emanuel (D-IL), and Senators Charles Schumer (D-NY), Hillary Clinton (D-NY), Debbie Stabenow (D-MI), Patrick Leahy (D-VT), Susan Collins (R-ME) and David Vitter (R-LA).

"For those who suffer from life-threatening illnesses, biopharmaceuticals provide great hope, but without generic versions of these medicines, countless Americans will be unable to share the hope these medicines provide," said GPhA President and CEO Kathleen Jaeger. "By creating a safe, clear and efficient abbreviated approval pathway, this critical bipartisan legislation will save consumers and our health care system billions of dollars and bring the true promise of these life-saving medicines to patients in need."

Biopharmaceuticals are everyday medicines used to treat conditions like heart disease, multiple sclerosis and cancer. The market for these medicines is growing at an astonishing rate-almost twice the rate of traditional medicines-accounting for approximately $30 billion in U.S. sales, about 12% of the total pharmaceutical market. Yet, in spite of this tremendous growth opportunity for these life-saving treatments, their high cost puts them out of reach for many Americans. Some biopharmaceuticals can cost up to $200,000 per patient per year. For example, treatment with the colon cancer drug Avastin costs $100,000 per year. And Cerezyme, used to treat Gaucher disease, costs an average of $200,000 per patient per year-with some adult patients paying more than $500,000 a year.

With estimated costs of 10% to 25% less than brands, biogenerics have the potential to save the health care system billions of dollars. According to a study by the Pharmaceutical Care Management Association, biogenerics would save the Medicare Part B program alone $14 billion over 10 years. Additional savings also would accrue to Medicare Part D and other government health care programs, such as Medicaid and the Department of Veterans Affairs.

The Act will set forth a clear, efficient abbreviated FDA approval pathway in order to bring safe, effective and affordable biogenerics to consumers. Without such a pathway, millions of Americans will be unable to obtain the medicines they need at a price they can afford. Under this science-based, clear and efficient pathway, FDA will have the authority and flexibility it needs to request from generic companies the necessary data and tests on a product-by-product basis to ensure safety and efficacy. With more than 20 years of experience and scientific advances, FDA now has even more sophisticated scientific tools to ensure safety and efficacy than it did when it first approved the parent biopharmaceuticals that now are coming off patent.

"Safety is and always will be our number one priority. That's why we support the approval pathway created in this legislation that gives the FDA the authority it needs to ensure safety, efficacy and timely access to affordable biogenerics," Jaeger stated. "Under the legislation, FDA would let sound science drive the approval process for biogenerics, just as it does today for biopharmaceuticals."

Additionally, recognizing that biogenerics will only truly be life-saving treatments if they are able to reach the market, the legislation calls for timely resolution of patent disputes. It is imperative that needless barriers to consumer access are eliminated so that the true promise of biogenerics can be achieved, Jaeger noted.

"Momentum is growing for this critical legislation and we thank the co- sponsors from both sides of the aisle for their leadership," Jaeger stated. "For more than 20 years, generic medicines have been improving lives for less. It is time for Congress to make certain that FDA creates a clear and efficient abbreviated approval pathway for biogenerics. Only then will biogenerics be able to begin to start improving the lives of millions of Americans who currently cannot afford the high costs of brand biopharmaceuticals."

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 56% of the total prescriptions dispensed in the United States, but only 13% of all dollars spent on prescription drugs.
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