03/18/2010 05:12 am ET | Updated May 25, 2011

The Fight For Biogenerics

You know a health care bill isn't right for the American people when it carves out a legal monopoly for Big Pharma and Botox, but I suppose it helps when the sponsor of these Congressional goodies is good friends with the Speaker of the House.

If there were an award for Congressional monopolist of the year, it should go to Representative Anna Eshoo of California, who, very quietly, has served to hand Allergan, the maker of Botox, and Amgen, the main opponent of affordable generic biotech drugs, the guaranteed market protections for which they have so aggressively lobbied.

Eshoo should know better. But the lobbying for special interests this year has been intense. An expose last month on how K Street has mobilized to get what it wants in health care reform by Time revealed some startling facts: biotechnology and pharmaceutical companies have hired an army of 1,228 attack dog lobbyists - that's 2.3 lobbyists per every member of Congress.

One of the biggest issues in this debate centers around biologic drugs, which represent the cutting edge of medical and pharmaceutical innovation. Biologics provide therapies for a range of life-threatening illnesses like multiple sclerosis, anemia, hemophilia, cancer, diabetes, HIV and rheumatoid arthritis, but are exorbitantly expensive. These drugs cost up to 22 times more than standard medications - some as much as $400,000 annually. And while regular pharmaceuticals have cheaper generic alternatives, in the United States there are no legally available generic versions of biologics, called biogenerics.

How has Congress proceeded to handle this delicate issue? Congressional leaders like Eshoo and the late Sen. Kennedy sponsored the excessively long exclusivity provisions of 12 years for these drug makers, virtually squeezing any incentive for the generic industry to compete right out of the market. By comparison, the landmark legislation that created the generic drug industry, the Hatch Waxman Act of 1984, gave drug makers 5 years of exclusivity protection.

Despite the White House's opposition to 12 years, there has been silence throughout the debate. What should be an easy decision for Congress and the Obama Administration has turned into an embarrassing but not unfamiliar story of money and influence in a Washington so many had hoped would change.

The lobbying dollars spent on protecting the 12-year Amgen barricade are obscene. In the first six months of 2009, BIO and PhRMA spent $110 million in lobbying - roughly $600,000 per day -- to further guarantee that the stranglehold they currently have on biologic drugs is unaffected by current health reform efforts.

Last week, the New York Times reported that lobbyists for bio-tech giant, Genentech, have successfully ghost-written language for more than 20 members of Congress in support of 12 years exclusivity.

Eshoo bears the taint of these lobbying expenditures too. Her district, which is home to Allergan, has received more than $1.4 million in political contributions from pharmaceutical and biotechnology companies including Amgen, Johnson & Johnson and Roche, the parent company of Genentech. And even Kennedy was not blameless as his Senate library received one of the largest donations in history - $5 million - from Amgen.

This K Street offensive have also succeeded in drowning out the AARP, AFL-CIO, Consumers' Union and dozens of other consumer and trade groups whose members must grapple with the growing costs of biologics each and every day.

Given President Obama's call for sweeping change of how Washington does business, it seems unimaginable that Congress and the Obama Administration could fall prey to biopharmaceutical lobbying efforts - but sadly, that's exactly what's happening. Debra Barrett, Senior Vice President of Government Affairs for Teva North America, the world's largest generic drug maker, put it this way: "Congress is missing an enormous opportunity to create a competitive biologics marketplace. Washington has come up with a pathway to nowhere. It won't help patients with drug costs and it certainly won't promote competition."

And although President Obama has supported opening up the drug market to biogenerics sooner than Big Pharma wants, his platitudes about industry competition and consumer choice fall short when push comes to shove.

There has been radio silence from the White House as this battle ensues on the Hill, probably because of the president's recent meetings with representatives from Big Pharma. And while we'll never know exactly what went on at those closed-door rendezvous at the White House, we do know one thing for certain - the drug industry got exactly what it wanted.

In spite of President Obama's oratory about stemming the influence of special interests in Washington, lobbying seems to be alive and well in the nation's capital. And in the meantime, those who are desperately waiting for more affordable biologic drugs don't seem to realize that the president's call for affordable health care for all Americans is a dream that may never be realized.

It's sad when patients who cannot afford medicines see their chances dim in a bill that does nothing to put prices in reach for the average American. Our Congressional leaders should be capable of more. Perhaps all of the Botox went to their heads.

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