On 14 January 2010, as US House and Senate conference negotiators continued working round the clock to agree a compromise health-reform bill to send to the President for signing, Pharmaceutical Research and Manufacturers of America (PhRMA) President Billy Tauzin told the group’s board members in an email that Representative Henry Waxman – who chairs the powerful US House Energy and Commerce Committee – “is pushing hard, with the support of the President, to drop our 12-year FOB (follow-on biologics) period down. We are letting everyone we know hear that we could not support the bill if this happens”.

In fact, both the US House and Senate reform bills would provide innovator firms with the 12 years’ protection they seek, but the President has long maintained that seven years is adequate. In a private meeting on 14 January 2010, President Obama refused to accept the arguments of US House Democrats that he should support the 12 years, because that is what has been agreed by the US House and the Senate, according to sources close to the talks.

James Greenwood, President of the Biotechnology Industry Organisation (BIO), said this was “outrageous,” given that the issue had been “overwhelmingly settled months ago in both the House and the Senate”.

It is not reported whether the President is still pushing for a maximum of seven years, but sources suggest that he and Representative Waxman could be looking at between seven and 10 years.

Twelve years’ guaranteed patent protection for biologicals was one of the industry’s conditions for agreeing in June 2009 to provide US$80 billion over 10 years towards the President’s health-reform drive, and specifically helping to close the Medicare prescription drug plan (Part D) ‘doughnut hole’ coverage gap for enrolees. However, the current White House negotiations have also included proposals for the industry to contribute a further US$10 billion to this effort, or perhaps even more, possibly by increasing the discount it provides from the already agreed 50- 75% of the prices of Medicare enrolees’ prescription medications once they hit the doughnut hole.

Complicating the biosimilars issue further is the special election on 19 January 2010 in Massachusetts - home to around more than 430 biotechnology companies - for the seat of long-term health-reform campaigner, the late Senator Edward Kennedy. The Democrats’ nominee, Attorney General Martha Coakley, had initially been expected to retain the seat comfortably, but the Republican contender, state Senator Scott Brown, has recently made considerable gains in the polls, which may threaten the protections for biologicals.

Reference:

Lynne Taylor. Obama battles Congress and PhRMA over biogenerics. 2010 January 18.