The bill is consistent with President Donald Trump’s statement last week during a meeting with drug industry leaders that he wants to reduce “astronomical” drug prices by boosting competition. But it’s not clear how much impact the bill would have on bringing cheaper drugs to market faster.
The Lower Drug Costs Through Competition Act would require the FDA to review applications for generic versions of drugs for which there is little or no competition with 180 days. It also would offer companies that submit such applications a voucher promising speedier review of another generic product.
“We all remember recent situations where bad actors jacked up the price of older, off-patent drugs because there was no competition,” said House Energy and Commerce Committee chairman Greg Walden (R-Ore.) in prepared remarks. “We want to make sure that doesn’t happen again.”
But the bill’s proposed 180-day review period is only a little shorter than the eight-month review and action goal set out by the FDA last year, and it’s longer than the four-month target proposed for certain priority drug applications. “The FDA already prioritizes new generic drugs where there’s no competition, I don’t know how much this adds to that,” said Dr. Aaron Kesselheim, a pharmaceutical policy expert at Harvard Medical School
Nearly identical legislation went nowhere last year. The Pharmaceutical Research and Manufacturers Association did not respond to a request for comment about the bill.
Harris Meyer is a senior reporter providing news and analysis on a broad range of healthcare topics. He served as managing editor of Modern Healthcare from 2013 to 2015. His more than three decades of journalism experience includes freelance reporting for Health Affairs, Kaiser Health News and other publications; law editor at the Daily Business Review in Miami; staff writer at the New Times alternative weekly in Fort Lauderdale, Fla.; senior writer at Hospitals & Health Networks; national correspondent at American Medical News; and health unit researcher at WMAQ-TV News in Chicago. A graduate of Northwestern University, Meyer won the 2000 Gerald Loeb Award for Distinguished Business and Financial Journalism.