Democratic lawmakers call for crack down on drug companies over system that can limit affordable options

WASHINGTON – Sen. Elizabeth Warren, D-Mass., and Rep. Pramila Jayapal, D-Wash., are pushing federal regulators to "crack down" on companies they say are preventing their competitors from producing lower-cost generic drugs for Americans. 

In a letter sent to the Food and Drug Administration Thursday night and seen exclusively by USA TODAY, the progressive lawmakers urged the agency to close loopholes that discourage competition among drug companies and keep prices high for crucial medication. That can include inhalers to help with chronic lung diseases.

Here's the system Warren and Jayapal are trying to address: The FDA keeps a list of all federally approved drugs, known as the Orange Book. The agency requires pharmaceutical companies to list in the book any valid patents they hold on drugs they created, signaling to competitors that they can’t create a generic alternative. Those alternatives often provide more affordable options for Americans.

But Warren and Jayapal have been arguing for months that major drug companies are exploiting that structure by updating listings with insignificant changes to extend the time it's protected from copycats. 

The Federal Trade Commission – the government’s consumer protection agency – has already agreed with the Democrats. It issued a new statement in September noting that improper listings may be illegal and “have likely been distorting pharmaceutical markets for decades.”

Prescription drugs in the United States are more than twice as expensive than they are in other large countries, according to the Department of Health and Human Services. Brand name drugs are even pricier – more than three times more expensive than in other nations.

In November, the FTC sent letters to ten drug companies warning them that they believe they are collectively listing more than 100 improper patents.

Warren and Jayapal sent letters to each of the companies following up on the FTC’s warning. Three of the ten companies did not say the flagged drugs were improper but did take them off the list, including several types of epinephrine injectors (often known by the brand name EpiPen) and inhalers.

But the other seven did not take down their listings, arguing in letters reviewed by USA TODAY that the government’s rules are murky or that their patents do qualify.

Warren in a statement urged the FDA to “crack down on this abuse.”

It’s the latest in lawmakers' inquiries into the way pharmaceutical companies impact drug pricing and availability in the United States.

Last week, the Senate's Health, Education, Labor and Pensions Committee grilled the CEOs of three major drug companies over the cost of necessary medications. The Biden administration is also bargaining with drug companies to make 10 widely prescribed drugs cheaper for older Americans.

The pressure from federal officials and outcry from Americans have pushed drug companies to change some pricing. In January, the industry implemented their lowest median price increase in over a decade.

This article originally appeared on USA TODAY: EpiPen, inhaler costs: Lawmakers call for crack down on drug companies