Why Genentech lobbyists are worth every penny

Figuring out the right rules for biotech drug development should be hard. But Big Pharma makes it easy

Published November 16, 2009 6:45PM (EST)

Robert Pear's New York Times scoop reporting that both Republican and Democratic legislators submitted statements to the Congressional Record that are word-for-word copies of materials written by Genentech lobbyists is one of those classic stories bound to make us feel warm and cuddly about how responsibly our government officials perform their jobs.

The Genentech lobbyists, who appear to be worth every cent the Bay Area biotech firm pays them, came up with two different position statements specially targeted to Republicans and Democrats, in reference to an amendment to the House healthcare bill recently passed by a razor-thin majority.

The Democrats emphasized the job creation aspect of the amendment.

Republicans opposed the bill, but praised a provision that would give the Food and Drug Administration the authority to approve generic versions of expensive biotechnology drugs, along the lines favored by brand-name companies like Genentech.

One important line repeated by at least two representatives: "I do believe the sections relating to the creation of a market for biosimilar products is one area of the bill that strikes the appropriate balance in providing lower cost options."

That's as much detail as Pear provides on the substantive issue at the heart of Genentech's concerns, but it's worth drilling down on a bit more, because it so aptly demonstrates a fundamental failure of government as currently practiced in the United States.

The "provision" that would give the FDA "authority to approve generic versions of expensive biotechnology drugs" is actually an amendment proposed by Democratic Rep. Anna Eshoo that would protect companies like Genentech from generic competition. Unsurprisingly, Eshoo represents the San Francisco Bay Area district in which Genentech is headquartered.

Specifically, the amendment gives producers of so-called biologics -- complex biotech drugs -- 12.5 years of "data exclusivity" protecting the test results associated with the development of a particular drug.

The test result data is critical to the formulation of "biosimilars" -- generic versions of complex, "large molecule" biotech drugs. There's a valid reason for this, which is explained coherently by Genentech on its own Web site. State-of-the-art biologics are created through a manufacturing process so complicated and sensitive that even the  smallest differences in the process can result in significant differences in the structure and effect of the resulting drug, even if the end product "looks" more or less similar to the original. The biotech industry position is that since generic versions of these drugs will be manufactured differently than the originals, they should go through the same extensive safety testing process as the originals did before being ruled safe for human use.

Of course, if the generic manufacturers were required to spend the same amount of time and money proving the safety of their drugs as the original manufacturers, there wouldn't be much of a cost advantage for them. And that would negate the whole point of giving pharmaceutical companies limited patent durations for their drugs. As a society, we have decided that it makes good sense to limit the patent duration on drugs to 20 years. This encourages the biotech companies to keep making new drugs, and ensures that the cost of existing drugs steadily falls.

For the generic manufacturers to be able to successfully prove that their drugs are as safe as the originals, they need access to the test data compiled at great expense by the original manufacturers. And that's where the battle is currently being fought. Genentech and the rest of the biotech companies want to maintain test data exclusivity for as long as possible. The generics want a shorter period.

You can read a paper, funded by PHARMA, the lobbying organization for the big pharmaceutical companies, explaining why the period of test data exclusivity should be at least 12.9 and possibly as high as 16, years, to ensure that the drug companies can at least break even on their investment, here. And you can read a paper, paid for by a major producer of generics, explaining why the term should be only seven years, here.

This is not an all-or-nothing argument between information-wants-to-be-free absolutists and hardcore free-marketers who believe in eternal patents and the strictest possible intellectual property laws. This is a very granular argument. In a range from seven to 16 years, what period of test data exclusivity best serves the public interest?

In my ideal world, scientists and economists whose salaries were paid for by us, i.e., the government, would be conducting the research necessary to come up with a good answer to this very specific question.

But instead, we get Democrats and Republicans regurgitating statements about "appropriate balance" that have been written by lobbyists for companies that have a vested interest in the outcome of the bill.

And that's this week's installment in how the world does not work.

By Andrew Leonard

Andrew Leonard is a staff writer at Salon. On Twitter, @koxinga21.

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Biotechnology Healthcare Reform How The World Works Intellectual Property