Members of Congress have asked the Government Accountability Office (GAO) and the inspector general of the department of Health and Human Services (HHS) to take a look at pharmaceutical pricing practices. The requests came as a result of two studies and a subsequent story in The New York Times that showed pharmaceutical prices have increased during the year ending 30 September 2009 despite the Consumer Price Index declining during the same period.

The biotechnology industry should welcome the inevitable investigations that these requests will stimulate. What better chance to demonstrate to the world the reasons behind the high costs of biopharmaceuticals? What better opportunity for transparent, full disclosure that may help convince Congress and the public that price tags of up to $100,000 a year for biotech drugs are justified?

One of the reports that started this line of inquiry came from AARP, which in its November/December 2009 issue published an article titled “New Miracle Drugs .” The article explained in clear, layman’s language what biologic drugs are, how they’re made, and what they cost -- and it discussed the lack of a generic pathway for biologics. Although AARP continues to lobby for a generics process, it points out in the article that the savings from generic versions of biologic drugs would not be as dramatic as those seen in traditional pharmaceuticals. The article does a good job of explaining why biologic drugs are expensive.

The biopharmaceutical industry has argued for longer periods of exclusivity – longer-term patent protection – than some lawmakers want to give them. That’s been one of the sticking points in trying to develop a pathway for generic, or follow-on, biologics, also called biosimilars. The likely upcoming investigations of pharmaceutical pricing practices could be the exact forum the industry needs to prove its point. By making biopharmaceutical pricing transparent and comprehensible, the industry may gain points with both lawmakers and the general public.

Follow-on biologics are coming; the European Union already has a pathway for their approval in place. The biopharmaceutical industry has a unique opportunity here to demonstrate why its drugs are worth the cost and why originator companies deserve the longer exclusivity periods they are asking for.