Durbin, Cassidy Introduce Legislation To Lower Drug Prices By Promoting Generic Competition

07.31.24

Durbin, Cassidy Introduce Legislation To Lower Drug Prices By Promoting Generic Competition

The REMEDY Act would lower prescription drug prices and promote competition by removing barriers to FDA approval for lower-cost generic drugs

WASHINGTON - U.S.Senate Majority Whip Dick Durbin (D-IL) and U.S. Senator Bill Cassidy, M.D. (R-LA) today introduced a bipartisan bill to tackle certain efforts by the pharmaceutical industry to extend monopolies on lifesaving drugs. The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act, would promote competition by removing barriers to Food and Drug Administration (FDA) approval for lower-cost generic drugs. Many high-cost, brand-name drugs are shielded from competition because of the ability to obtain numerous additional patents to their product in an attempt to forestall generic competition. The REMEDY Act would crack down on these pharmaceutical monopolies and lower costs for patients.

"Americans are forced to pay sky-high prescription drug costs because pharmaceutical manufacturers often game the patent system to extend their monopolies, avoiding competition from lower-cost generic drugs. These abusive practices do not promote innovative research and don't serve the best interests of patients," Durbin said. "The REMEDY Act will increase competition and help reduce drug costs by curbing patent manipulation by Big Pharma."

"No matter where I go in Louisiana people always mention the high cost of prescription drugs," said Dr. Cassidy. "To lower the cost of drugs we need to increase competition. Getting generics to market faster increases access and saves money for patients and taxpayers."

The REMEDY Act would address a perverse incentive for brand-name drug manufacturers to amass secondary patents to stifle generic competition. Under current law, whenever a generic drug applicant challenges certain categories of patents covering a brand, that automatically triggers a 30-month stay of FDA approval for the generic, regardless of the circumstances of the case and irrespective of how peripheral the brand's patents may be to the generic's application.

The top 10 best-selling drugs each have an average of more than 70 patents, three-quarters of which were obtained after the drug came to market. Because a generic's challenge to any of the patents listed in FDA's Orange Book for the brand-name drug automatically freezes the status quo for 30 months, brand-name manufacturers are incentivized to obtain as many patents as possible.

The Federal Trade Commission (FTC) recently took actions directly linked to this issue, by challenging hundreds of patents that they believe were improperly listed in FDA's Orange Book. TheREMEDY Act would narrow the scope of the 30-month stay by requiring the brand-name manufacturer, upon FDA approval of its drug, to identify which single patent would receive the 30-month stay if challenged.

The REMEDY Act would remove incentives for drug manufacturers to file additional patents, and would lift barriers that delay generic market entry. Under this policy, generic drug manufacturers would be allowed to enter the market more easily, by having more certainty and visibility into the patent landscape.

In May, Durbin chaired a Senate Judiciary Committee hearing that scrutinized pharmaceutical companies' abuse of the Orange Book and examined drug prices, competition, and how to ensure medications are accessible and affordable for patients.

The bipartisan REMEDY Act is endorsed by AARP, Patients for Affordable Drugs Now, and the Campaign for Sustainable Rx Pricing.

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