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Health care bills grant billions to Big Pharma, prevent generic competition

 HARPSWELL —  As a medical student, I am constant witness to the struggle that patients endure to cover the cost of brand-name prescription drugs. Yet drug manufacturers are finding ever more stringent ways to maintain the linchpin on pricing.

During the beginning of 2009, the pharmaceutical industry invested $1.2 million per day Congress was in session lobbying lawmakers. This lobbying bore fruit in the form of a provision included in the health care reform bills at the behest of manufacturers that would earn the industry a projected $71 billion extra off U.S. taxpayers in the upcoming decade alone.

In recent months, the Senate and the House health committees passed proposals meant to create a pathway for generic versions of prescription drugs called ''biologics'' to come to market when they passed their health care reform bills.

However, these proposals will accomplish the opposite of what they are meant to do by creating unjustifiably long and often perpetual monopolies for brand-name biologics drugs, which will stifle both innovation and much needed price-lowering generic competition.

Biologics -- medicines made from living organisms -- are among the most medically important drugs to date and include vaccines and drugs used treat diseases like breast cancer and leukemia. They comprise a quarter of all new drugs approved by the FDA and will account for half of approvals in the next few years.

Unfortunately, biologics are on average 22 times more expensive than traditional drugs. Medicines like Novartis's Gleevec for leukemia at $56,000 per patient, and Wyeth's Enbrel for Rheumatoid Arthritis, at $26,000 annually, comprise some of the priciest medications on the market.

Epogen, which costs $84,000 a year per patient, is used to treat anemia in end-stage kidney disease, and accounted for the single greatest Medicare Part D expenditure in 2005 at $1.75 billion.

Generic biologic drugs could provide savings that would reduce the strain on the Medicare budget. Unfortunately, current health bills guarantee brand-name biologics 12 years of exclusivity, although conventional drugs receive five years.

The industry argues that these extended protections are necessary to recoup R&D costs for biologics. However, according to PhRMA's 2009 Industry Profile, the average research and development costs for a biologic ($1.2 billion) are comparable to those of a conventional drug ($1.3 billion).

Industry also cites that length of clinical development is longer for biologics (97.7 months) than conventional drugs (90.3 months). But given that the costs of development are comparable, why should Congress grant seven extra years of exclusivity for biologics when they only take seven months longer to develop?

The Federal Trade Commission suggested zero years of exclusivity, recognizing that it is already more difficult for generic biologics to come to market than for other drugs.

More troubling is that the biologic provisions in the current bills contain ''evergreening'' loopholes that would allow pharmaceutical companies to make minor tweaks (changing dosages or formulations and combining therapies) renew the 12 years of market exclusivity. They can make these minor changes repeatedly, yielding perpetual monopolies.

Clearly, special interest politics rather than evidence-based policies have prevailed thus far.

History, however, presents to us a better option. In the last 10 years, the Waxman-Hatch Act of 1984 has saved the U.S. $734 billion by providing an effective conduit for lower-priced, generic conventional drugs to come to market.

Now, 25 years later, Rep. Henry Waxman has introduced another bill meant to strike the same delicate balance by affordable medicines and industry incentives.

He proposes five years of data exclusivity for new biologics -- the same amount given to conventional drugs -- and narrows the loophole that could stifle new drug creation and create indefinite monopolies.

There is still an opportunity to fix the Senate bill and create generic biologics provisions that allow no more than five years of exclusivity and close the evergreening loophole.

- Special to the Press Herald