An 11th-Hour Battle Over Biogenerics In Congress
3 CommentsBy Ed Silverman // January 14th, 2010 // 8:44 pm
Some late-in-the-game, behind-the-scenes dealmaking appears to be under way involving generic drugmakers, the White House and Henry Waxman, who chairs the House Energy & Commerce Committee over granting biotechs 12 years of exclusivity against biogenerics, the Associated Press writes. The skirmishing comes as Congress edges closer to a final version of health care reform legislation.
The drive to shrink the protection period to a rumored 10 years has prompted opposition from the pharmaceutical industry, which argues the longer period is needed to encourage investments needed to produce biotechs. “Fair data protection of at least 12 years is critically important to the future of medical progress in America,” Ken Johnson, PhRMA’s senior vp, tells the AP.
Three dozen patients groups and research universities wrote a letter backing the 12-year period to House Speaker Nancy Pelosi and Senate Majority Leader Harry Reid, claiming it would balance patient access to drugs with incentives for companies to invest in development. Senators from California, Massachusetts and other states with industry players also wrote Reid to preserve the 12 year period.
Pharma has been a key supporter of President Barack Obama’s effort to reshape the health care system, the AP notes, adding drugmakers are under pressure to boost the $80 billion, 10-year contribution they agreed to make to the overhaul last year. The effort to reduce the exclusivity period could be a way for the White House to pressure industry to pay another $10 billion (see here), or make it easier for Obama to show the $80 billion deal with drugmakers will benefit consumers.
Fred Nelson
Moving the exclusivity period down from 12 years could be costly to the BioTech Industry. They had thought they dodged a bullet. Interestingly Obama believes 7 years is to right number.
Also, with regard to the additional $10 billion from Pharma… This apparently will go to fill the Donut Hole which may signal a shorter time frame to close the Donut Hole. Last week Senator Whitehouse from RI said that there were discussion to close it sooner than 2019 which is in the House legislation. Could these be the funds earmarked to close it sooner?
Outside the Box
Surely someone at PhRMA can calculate the likely value to the industry of each additional year of bio exclusivity and as a result come up with a proposal to reduce the time to close the donut hole in return for longer exclusivity? Given that this whole process has been one big horse trade why not make it clear that this is what is being done?
M. Black
I think the larger, more looming issue is the fact that many if not most (including pharmacists) truly believe that a generic is equally as potent as a brand name drug. If patients can’t tell the difference, they likely either do not need the prescribed medication, or may have been misdiagnosed. Depending on the illness and generic drug used to treat it, this can be fatal.
That is not acceptable.