Lawmakers seek to close drug company loophole

Warren, Jayapal says improper patient impede low-cost generics

By: Riley Beggin
USA Today

WASHINGTON - Senator Elizabeth Warren, D-Massachusetts, and Representative Pramila Jayapal, D-Washington, 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 on Thursday [02/15/2024] 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.
..... Under 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 form months that major drug companies are exploiting that structure by updating listings with insignificant changes to extend the time their products are protected from copycats.
..... The Federal Trade Commission - the government's consumer protection agency - has already agreed with he lawmakers. It issued a new statement in September [2023] noting that improper listings may be illegal and "have likely been distorting pharmaceutical markets for decades."
..... Prescription drugs in the United States are more in other large countries, according to the Department of Health and Human Services. Brand name drugs are even pricier - more then three times more expensive as in other nations.
..... In November, [2023] the FTC sent letters to 10 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 10 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' inquires into the way pharmaceutical companies affect drug pricing and availability in the U.S.
..... On February 8, [2024] the Neatness'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 form Americans have pushed drug companies to change some pricing. In January, [2024] the industry implemented its lowest median price increase in over a decade.

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