Pharma’s spring offensive
During an off-year legislative season when most of the public’s attention is already focused on who will succeed Obama in the White House, one of the best-heeled lobbying forces in the nation’s capital—the pharmaceutical industry—is closing in on a set of legislative triumphs that threaten to undermine healthcare affordability at home and abroad for years to come.
The 21st Century Cures Act now marching through Congress would lower the bar for approving high-cost drugs of unknown medical utility. It also opens the door to more extensive and easily disguised pharmaceutical marketing.
Poorly controlled drug marketing poses a threat to everyone concerned about rising healthcare costs. Take, for instance, the approval last week of two new biologic drugs that lower “bad” cholesterol levels more than statins, which are now generic. Those drugs could wind up costing the healthcare system $23 billion annually.
Though approved only for people with familial hypercholesterolemia (a genetic disease), adroit marketing could make those monthly shots a popular off-label item for physicians convinced that “lower is better.” However, the manufacturers have yet to produce clinical trials showing these drugs are any better at reducing the risk of heart attacks and strokes than statins.
Meanwhile, the Trans-Pacific Partnership trade bill being pushed by the Obama administration contains intellectual property provisions that would limit the ability of developing countries to acquire generic or less-costly versions of branded products. The bill also extends clinical-trial data protection to 12 years, not the seven called for in Obama’s last budget, which would have saved $4 billion over the next decade by allowing earlier access to generics.
An early version of the bill cut hospitals’ Medicare payments to offset costs. Though that provision has been eliminated, the fact that few on Capitol Hill question the bill’s patent or data provisions is testimony to the drug industry’s enduring influence over both Republicans and Democrats in Washington.