For months the biotechnology drug industry thought its health care reform wish list was pretty much in the bag. But recent moves by the Obama administration have forced it to make another big push to convince lawmakers not to jeopardize an emerging industry’s bottom line.

The threat: the White House’s move to reduce the amount of protection brand-name drug companies would have for groundbreaking biologic drugs before their generic competitors can use their data to produce cheaper, similar versions. Considering that the average single biologic takes 10 to 15 years and $1.2 billion to research and develop (and that’s not including any new special facility costs or other capital costs that a firm may incur), big money is clearly at stake for the industry.

Compared to traditional, small-molecule chemical drugs, biologics—drugs that offer the best hope for finding new cures and treatments to debilitating diseases such as cancer, AIDS, Alzheimer’s, and rheumatoid arthritis—are highly complex and made of larger living molecules. Their composition makes them virtually impossible to replicate. Attempts to produce generic, yet not-quite-the-same, versions are referred to as “follow-on biologics,” or “biosimilars.”

Drug companies were successful in getting a 12-year data-exclusivity period included in both the Senate- and House-passed versions of health care reform, despite protests from generic firms, consumer and patient advocate groups, and others who argued that a longer exclusivity stretch essentially amounts to a market monopoly on expensive drugs. The exclusivity period is a time during which generics cannot access brand companies’ test data to make their own versions. Generic firms are, however, free to bring to market their own biologics using their own data before 12 years is up.

There’s also patent protection—drug companies usually get a 20-year patent for their products, a period which is supposed to run concurrently with the exclusivity period. Brand-name companies say the exclusivity period is necessary because biologics are nearly impossible to replicate, so it’s easy for competitors to work around the patent and create their own products.

Shoe-Leather Politics vs. Emotion

Last year, after President Obama entered office with health care reform at the top of his legislative agenda, the pharmaceutical industry largely had the upper hand in ensuring Washington embraced its positions on biologics. Part of its success is the early agreement it reached with the White House to get $80 billion in health care cost savings. But old-fashioned lobbying efforts, especially on the complicated topic of biologics, also played a role.

In the months before legislation had gotten very far, Jim Greenwood, president of the Biotechnology Industry Organization (BIO), would go door-to-door on Capitol Hill armed with images and models showing the molecular differences in a chemical drug like aspirin and a biologic drug like epoetin. “It’s just been good old-fashioned, shoe-leather politics,” he said of the work of BIO and others from the brand-name drug industry (a.k.a. Big Pharma).

Consumer and patient-advocate groups, on the other hand, based their own lobbying campaign more on emotion than science. They say consumers should have access to cheaper biologic drugs sooner—as a matter of life or death, as well as economics. “In this country, we have allowed health care to become an industry, and so our health conditions are someone else’s business opportunity,” said Joana Ramos, director of the Washington State Coalition for Prescribing Integrity and a cancer survivor.

For a long time, it appeared the efforts of Greenwood and others won out over those of Ramos and her colleagues. But just as the January 19 surprise election of Republican Scott Brown to fill liberal icon Ted Kennedy’s Senate seat in Boston altered everyone’s big-picture strategy toward health care reform, the White House appears to be taking a fresh look at the biologics issue.

The Obama administration has been working with House Energy and Commerce Committee Chairman Henry Waxman, a California Democrat—considered more of an ally to the generic and consumer side of the debate—as well as leadership in both the House and the Senate to slip a shorter exclusivity period into the bills. The administration in the past said seven years’ exclusivity, rather than the previously agreed upon 12 years, was “generous.”

“We think it’s both bad policy and bad precedent,” Jeff Joseph, BIO’s vice president of communications, told Portfolio.com, adding that a shorter exclusivity period would jeopardize innovation, jobs, and U.S. leadership in medicine. “Of all the things that are so contentious in health care reform—whether it’s abortion…this is one of very few issues where there was not only bipartisan consensus…but also bicameral support.”

Billy Tauzin, the president of the Pharmaceutical Research and Manufacturers of America, reportedly told his members via email that PhRMA could not support the bill if protection was reduced. PhRMA is not commenting to confirm that email, but that organization has also been satisfied with the "12 years" language.