(Story updated 2/28/17)
A key House committee will take up bipartisan legislation this week to reduce prescription drug prices by speeding up Food and Drug Administration approval of high-cost generic products which lack competition.
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.
Groups pushing for drug price relief hope to use the bill as a vehicle for tougher measures.
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. The bill is sponsored by Republican Rep. Gus Bilirakis of Florida and Democratic Rep. Kurt Schrader of Oregon.
“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 the FDA established for implementation this year, and it's longer than the four-month target proposed for certain priority drug applications. That's according to an analysis by Kurt Karst, an attorney who focuses on drug regulation at Hyman Phelps & McNamara.
“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.
Kesselheim also raised questions about whether priority review vouchers would have any impact on promoting generic competition, since there's no evidence they've worked in the brand-name drug space.
But a spokeswoman for Schrader said the bill provides added incentives to companies to develop a broader range of generic drugs, and requires the FDA to report to Congress on its backlog of generic drug applications.
Nearly identical legislation went nowhere last year.
The Pharmaceutical Research and Manufacturers Association did not comment on whether it supported the bill, but it said timely review and approval of generic products “can play an important role in fostering robust competition."
Those seeking action on drug prices point to bipartisan bills introduced in the Senate last year as stronger remedies. One bill, co-sponsored by Republican Sen. Charles Grassley of Iowa and Democratic Sen. Amy Klobuchar of Minnesota would make it easier for generic producers to gain access to brand-name products to conduct testing of generic versions prior to the branded product's patent expiration.
Grassley and Klobuchar also co-sponsored a bill to make it illegal for brand-name and generic manufacturers to enter into purported payoff agreements to delay the introduction of generic products.
Some observers say the House bill just introduced by Bilirakis and Schrader is a response to strong public pressure to address drug prices but that it wouldn't do as much as last year's Senate bills.
“They feel they have to do something and that this is the least they can get away with,” said one lobbyist, who didn't want to be identified.
(Correction: The story originally indicated Democratic Rep. Kurt Schrader was from Colorado. Schrader is from Oregon. )
