WASHINGTON, DC — A bipartisan group of U.S. Senators urged the Food and Drug Administration (FDA) to ensure timely access to generic biologic drugs for consumers and reject efforts to further block or delay affordable generic competition. The Senators asked the FDA to disregard efforts which, if implemented, would needlessly delay consumers’ access to generic biologics – drugs that make up an increasingly-large share of the market and treat diseases and conditions such as cancer, Multiple Sclerosis, and rheumatoid arthritis. The letter, sent to FDA Commissioner Margaret Hamburg, was led by U.S. Sen. Sherrod Brown (D-OH) and signed by Senators John McCain (R-AZ), Charles Schumer (D-NY), and Tom Harkin (D-IA).

“As it stands, brand-name pharmaceutical companies will enjoy a 12-year monopoly on life-saving drugs that treat cancer, Multiple Sclerosis, and rheumatoid arthritis. Making patients wait 12 years for affordable generic alternatives is unconscionable, but making them wait even longer would be a travesty,” Brown said.  “We must make every effort possible to prevent further delays and get affordable life-saving medicines into the hands of patients in need.  By preventing generic competition, American patients suffer and our federal health programs incur additional costs at a time of record deficits.”

“Our policies and regulations must continue to encourage American health care innovation in the field of Biologics, but it is also our responsibility to ensure all Americans have access to affordable therapies through a fair, competitive generic biologics pathway,” said Senator John McCain.  “While I continue to believe 12 years of protection for brand-name pharmaceutical companies is excessive, access to affordable generic alternatives should not be further delayed.”

"The FDA needs to realize that fair competition is as American as apple pie," Senator Schumer said. "That is why I have long believed that the FDA should do everything in their power to ensure that consumers have timely access to affordable generic biologics."

Prior to passage of the Affordable Care Act, there was no pathway for the FDA to approve generic versions of biologic drugs. These drugs – on which Americans spent more than $40 billion in 2007 – are expected to make up half of the sales from the Top 100 medicines by 2014. Recognizing the potential for significant cost savings and improved access to needed medications, the Affordable Care Act establishes a path to approval of generic versions of biologic, but one that ensures brand-name manufacturers 12 years of market exclusivity before generic versions can be sold.  The Senators today asked the FDA to reject misinterpretations of the law that – if followed – would prohibit the agency from even reviewing generic applications during the 12 year monopoly period, which would preclude generic alternatives from being ready to go to market after the 12-year monopoly period ends. This would further delay the development and availability of generic biologic drugs - with adverse effects for consumers and taxpayers.

A full copy of the letter can be found below:



January 24, 2011


Dr. Margaret Hamburg


Food and Drug Administration

10903 New Hampshire Ave

Silver Spring, MD 20993



Dear Commissioner Hamburg:


As Senators who were actively involved in the debate over the Biologics Price Competition and Innovation Act (BPCIA), we are extremely concerned about possible misinterpretations – whether intended or unintended – that could further delay the availability of generic biologic drugs, restricting access for many Americans and driving up costs for the federal government.


Biologic medicines are a relatively new frontier in patient care – expected to make up half of the sales from the Top 100 medicines by 2014 – and offer great promise for future treatments and therapies for patients.  In 2007, Americans spent $286.5 billion on prescription drugs; $40.3 billion of which was spent on biologic drugs.  A 2009 report by the Federal Trade Commission (FTC) found that a year’s worth of a popular biologic treatment for breast cancer can cost $48,000.  Like many Americans, we are concerned that the cost of biologics will continue to be an increasingly significant contributor to healthcare costs for both the nation and the individual consumer.


Under the BPCIA, your agency has new authorities to bring generic biologic medicines to the American consumer.  As the Food and Drug Administration (FDA) reviews comments regarding the implementation of the approval pathway for generic biologics, we respectfully request that the agency disregard any interpretation that would result in further delay of the availability of generic biologic drugs. 


It should be noted that we remain opposed to the 12 years of exclusivity that was granted to protect brand-name biologics from market competition – current law results in limited access for patients who cannot afford these therapies and higher costs for the federal government.  It has recently been brought to our attention that the FDA has received suggested statutory interpretations which, if implemented by the FDA, could result in generic competition being delayed well beyond the 12 year exclusivity period in statute.  We believe the statute is clear that the FDA can begin reviewing biogeneric applications during the 12 year exclusivity period.


Absent generic competition, biologic drugs will continue to cost patients thousands of dollars for a single dose.  Therefore, we strenuously object to any efforts that would further block or delay generic competition at the expense of patients in need.  We hope to work with you as your agency develops the generic biologics approval pathway under the BPCIA.








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Sherrod Brown (D-OH)                                              John McCain (R-AZ)






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Charles Schumer (D-NY)                                           Tom Harkin (D-IA)