The US House of Representatives could vote later this week on its controversial health reform bill, which analysts say could cost drugmakers as much as $150 billion over a decade.

Measures in the current House version of the Affordable Health Care for America Act (HR 3962), which was unveiled by Speaker Nancy Pelosi late last week, include requiring firms to provide drug rebates for people enrolled in both Medicare and Medicaid – costing the industry an estimated $60 billion over 10 years - and empowering the federal government to negotiate drug prices for the Medicare prescription drug programme.

The industry has long fought both proposals, and it is widely reported that, as part of the $80 billion, 10-year cost savings deal agreed in June between the industry and Senate Finance Committee chairman Senator Max Baucus - and “blessed” by the White House – drugmakers had been assured that any such initiatives were now off the negotiating table.

However, House Democrats have constantly maintained that as they had no part in negotiating the deal between Sen Baucus and the Pharmaceutical Research and Manufacturers of America (PhRMA), they are not beholden to it.

Late last week, PhRMA said that HR 3962’s plans to almost double the amount of money to be extracted from drugmakers were “problematic,” and the group’s senior vice president, Ken Johnson, told the AP that the $80 billion pledged by the industry was a “huge amount of money” and not “loose change we found sitting around in the sofa.”

PhRMA also points out that the Congressional Budget Office (CBO) has warned that the proposed rebates would ultimately lead to a 20% increase in premiums paid by Medicare enrolees for the prescription drug provision, known as Part D.

“What’s more, according to CBO, imposing a mandatory rebate on Part D prescription drugs would reduce incentives to invest in the R&D of new discoveries for diseases – such as Alzheimer’s and Parkinson’s disease – that disproportionately affect the elderly. This could have devastating consequences for millions of American patients and their families” and “lead to catastrophic job losses and cuts to R&D,” said Mr Johnson.

HR 3962 would also create a regulatory pathway at the Food and Drug Administration (FDA) for generic versions of biologic drugs but, in a rare bit of good news for brand-name drugmakers, it echoes the Senate reform bill by proposing to provide them with a basic and extendable 12 years’ market exclusivity. The Generic Pharmaceutical Association (GPhA), which represents the generics industry, responded to this by firing off a letter to President Barack Obama, asking him to strike from the reform legislation this “fatally flawed” language which is, the group said, “arguably worse than the effective monopoly that the biotech industry enjoys because it represents an empty promise to Americans who may falsely believe that the legislation will provide for meaningful competition.”

The GPhA letter points out to Pres Obama that the White House has itself concluded that no more than seven years’ exclusivity is necessary, and the Association’s chief executive, Kathleen Jaeger warned him: “any bill that delivers an empty promise to patients seeking access to affordable biogenerics while bestowing one of the biggest windfalls to the brand/bio pharmaceutical industry in 25 years clearly contracts the fundamental tenets of health care reform.”

In turn, her letter drew a sharp response from Jim Greenwood, chief executive of the Biotechnology Industry Organization (BIO), who said GPhA’s call to Pres Obama to strike the 12 years’ exclusivity from the reform legislation represented “a cruel trick to the millions of patients who are awaiting the benefits of biosimilars.” He accused GPhA of continuing “to bend the truth about biosimilars and the language passed in the House and Senate Committees,” pointing out that providing a company with data exclusivity does not give it or extend any sort of monopoly.

“Products that complete with innovative biologics can still be introduced during the period of data exclusivity - they just cannot piggyback off of the research conducted by the innovator company. They must conduct their own safety and efficacy research and testing to obtain FDA approval and, obviously, not infringe the patents of the pioneering company,” says BIO.