Senators urge FDA action on biologics approval

FDA poised to announce decisions on biologic generics’ entrance into market

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WASHINGTON, D.C.—As the U.S. Food and Drug Administration (FDA) decides whether to introduce early price competition to brand-name drugs by generic rivals, consumers, healthcare providers, pharmaceutical companies, Congress—and even President Obama—hold their collective breath.

With a multibillion-dollar drug industry on the line, the stakes are high.

Prior to passage of the Patient Protection and Affordable Care Act last year, 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.

The act not only establishes a path to approval of generic versions of biologics, but one that ensures brand-name manufacturers 12 years of market exclusivity before generic versions can be sold. It is that exclusivity that is being challenged.

After hearing from both sides in the debate, FDA Commissioner Margaret Hamburg said on Feb. 18 that regulators would unveil rules for reviewing the first copies of biologic medicines "very soon."

The FDA is also evaluating whether to require extensive clinical trials to judge whether the so-called biosimilars work as well as the products they copy, Hamburg said.

Biotech medicines, or "biologics," are derived from proteins and used to treat cancer, rheumatoid arthritis and other diseases. Some cost tens of thousands of dollars a year per patient, adding a big cost burden for insurers, Medicare and others who pay for the drugs.

President Obama has called for speeding up the availability of generic drugs, projecting billions in federal healthcare savings if the cheaper medicines are allowed on the market after seven years—instead of 12—saving federal healthcare programs $2.34 billion over the next 10 years. During that same time period, the administration estimated a $35 billion savings to American consumers.

However, the Biotechnology Industry Organization (BIO) has said that reducing exclusivity to seven years would prevent biotech firms from recouping their investments.

U.S. senators have expressed their points of view—and not necessarily along party lines.
In a letter dated Jan. 25, four bipartisan senators urged the FDA to allow for timely access to generic biologic drugs.

"We are extremely concerned about possible interpretations ... that could further delay the availability of generic biologic drugs, restricting access for many Americans and driving up costs for the federal government," stated a letter signed by U.S. Sen. John McCain, R-Ariz., and Democrats Sherrod Brown of Ohio, Tom Harkin of Iowa and Charles Schumer of New York.

The senators asked the FDA to disregard efforts that would needlessly delay consumers' access to generic biologics. Brown stated in the letter, "Making patients wait 12 years for affordable generic alternatives is unconscionable, but making them wait even longer would be a travesty."

Schumer stated, "The FDA needs to realize that fair competition is as American as apple pie. 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."

A 2009 report by the Federal Trade Commission found that "a year's worth of a popular biologic treatment for breast cancer can cost $48,000," the senators' letter said.

"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. We remain opposed to the 12 years of exclusivity that was granted to protect brand-name biologics from market competition," the letter states. "Current law results in limited access for patients who cannot afford these therapies, and higher costs for the federal government."

However, Amgen, maker of several top-selling biologics, told The Wall Street Journal that biotech-drug makers say they need 12 years protection from generics to pay for costly research, adding that Congress "intended data exclusivity to be an incentive for innovation."

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