As US consumers go to the polls “with access to affordable health care at the top of their minds,” generics - and biogenerics - “are the solution to reducing health care costs while increasing access to quality care,” according to Kathleen Jaeger, chief executive of the US Generic Pharmaceutical Association (GPhA), speaking as its annual conference got underway this week in Florida.

In 2007, generic drugs accounted for a record 65% of the US market, up from 63% the year before, according to new data from IMS Health reported at the meeting. Yesterday, leading US pharmacy benefit manager Express Scripts also noted the fast rise in the use of generics, reporting that their share grew from 40% to 58% of the total US prescription drug market during 2000-2006. The number of US consumers with at least one prescription increased from 57% to 74% over the same period, fueling additional spending of $12 billion for 2006 alone, it says, adding that without generics, that figure would have been much greater. “In fact, greater use of generic drugs still has significant potential for managing prescription drug costs. The key will be using an advanced understanding of the consumer to get more people to choose generics,” said Emily Cox, senior director of research at Express Scripts.

A 1% increase in use of generics saves US consumers $4 billion annually but, while cheaper copy versions of brand-name drugs now account for 65% of all prescriptions dispensed in the USA, they represent only 20% of all dollars spent on prescription drugs, says the GPhA. At the meeting, the Association unveiled an ambitious legislative programme for 2008, which is not only US presidential election year but will also see more than 10 leading prescription drug products, with combined annual sales of around $20 billion, lose patent protection.

For example, Merck & Co’s osteoporosis market leader Fosamax (alendronate) went off-patent earlier this month; others include Ortho-McNeil-Janssen’s schizophrenia treatment Risperdal (risperidone) and TAP’s Prevacid (lansoprazone) for heartburn and acid reflux disease. Moreover, in 2010 Pfizer’s Lipitor (atorvastatin), the world’s biggest-selling drug, will come off patent, and IMS has estimated that, by 2011, products worth around $60 billion a year will have lost protection.

The GPhA is calling this year for: supplemental funding for the Food and Drug Administration’s (FDA) Office of Generic Drugs; legislation to create a “workable” approval pathway for biogenerics at the FDA; more international free trade agreements; and the removal of “longstanding barriers to access” such as authorised generics and citizen petitions.

Both Democratic presidential hopefuls Hillary Clinton and Barack Obama, and the leading Republican contender John McCain, support measures aimed at getting generic drugs to market faster. Sen Clinton has also co-sponsored legislation which would give the FDA authority to approve biogenerics; she says that creating competition in this market will spur innovation and create savings of $5-7 billion per year.
However, Ms Jaeger has warned that any regulatory approval pathway for biogenerics that is “filled with roadblocks to access, including excessive market exclusivity provisions,” would be “an empty promise for countless patients who need these affordable life-saving medicines.”

And in a speech presented at the GPhA conference, New York Democratic Senator Charles Schumer, who co-sponsored the pathway legislation with Sen Clinton, stressed the need to achieve a balance of affordability, access and innovation. “We need a clean approval pathway that is driven by science and allows FDA discretion based on that science,” he added.