PhRMA, BIO, GPhA weigh in on healthcare-reform bill passage

WASHINGTON While calling it “not perfect,” an organization representing the country’s drug manufacturers called the healthcare-reform bill that the House passed Sunday “a step in the right direction.”

The Pharmaceutical Research and Manufacturers of America expressed the view Monday that healthcare reform would benefit patients and the country’s future.

The House sent the bill to Barack Obama’s desk after a vote of 219-212, with all the Republicans and 34 Democrats voting against the bill. The Senate had passed the bill on Dec. 24.

“The existing barriers to quality health care simply are not acceptable,” an organization statement read. “Today’s important and historic vote in the House will help to expand healthcare coverage and services to tens of millions of Americans who are uninsured and often forced to forego needed medical treatments.”

Meanwhile, the Biotechnology Industry Organization touted the bill’s provision for an abbreviated approval pathway for knock-off versions of biotech drugs variously known as biosimilars, biogenerics and follow-on biologics.

“The healthcare-reform bill passed by the House of Representatives last night includes key provisions that provide real solutions for our nation’s healthcare challenges and real hope for patients living with debilitating diseases such as cancer, multiple sclerosis, Parkinson’s, HIV/AIDS and many rare diseases,” BIO president and CEO Jim Greenwood said.

The bill provides for a 12-year data exclusivity period for biotech drugs, meaning that the Food and Drug Administration would have to wait until a biotech drug had been on the market for 12 years before it approved a biosimilar version. By contrast, the Generic Drug Association has pushed for a five-year exclusivity model, similar to the one that exists for generic pharmaceutical drugs. BIO argues that the 12-year model is necessary because it would prevent a biosimilar manufacturer from circumventing a biotech patent by making a drug that is functionally identical to the original but can be claimed to be different because it comes from a different cell line or has been modified in some way, while GPhA says that the 12-year model would deprive patients of access to cheaper alternatives to branded biotech drugs. The Obama administration has in the past pushed for a seven-year model.

For that reason, the bill’s passage got a less enthusiastic response from GPhA, which praised the bill’s closure of a gap in Medicare benefits called the “doughnut hole” and its expansion of healthcare access to uninsured Americans, but decried the provision for biosimilars.

“The bad news is that the bill provides a biogeneric pathway in name only, giving false hope to patients who desperately need access to life-saving biogeneric medicines,” GPhA president and CEO Kathleen Jaeger said. “Simply put, the bill fails to infuse competition and choice into the healthcare system due to the excessive and unprecedented market exclusivity protections for the brand industry.”