Published: September 2017

To reign in prescription costs, FDA should focus on drug manufacturers’ major abuses

In a letter to the Food and Drug Administration (FDA), advocates called on Commissioner Gottlieb to end regulatory abuses by brand-name companies that block access to generic drugs. Brand name drug companies twist the FDA's rules to delay or inhibit consumer access to generic drugs, which gives the companies the power to charge unreasonable prices, and leads to greater healthcare costs.

Generic drug competition has proven an effective way to help lower prescription drug prices and reduce overall healthcare costs. Unfortunately, some brand name drug companies have manipulated and twisted the FDA’s rules to delay or inhibit availability of generic drugs. This has given brand name drug manufacturers the power to charge unreasonable prices, which leads to greater healthcare costs, higher premiums, and increased out-of-pocket expenses for consumers who can least afford them.

There are three major areas of abuses the FDA should focus on: REMS (risk evaluation and mitigation strategies), abuse of the citizen petition process, and reformulations/product hopping. 

 

Lead Organization

Consumers Union

Other Organizations

Consumers Union | Patients for Affordable Drugs | Consumer Federation of America | Consumer Action

More Information

For more information, visit Consumers Union's website.

Download PDF

To reign in prescription costs, FDA should focus on drug manufacturers’ major abuses   (LettertoFDAonGenericDrugAccess.compressed.pdf)

 
 

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