Press Release

Congressman Ami Bera, M.D. and Congressman Scott Peters (CA-52) are leading a group of 28 members of Congress to urge the Food and Drug Administration (FDA) to take steps to reduce the sky-rocketing costs of generic prescription drugs.

In a letter to the FDA, they ask the agency to take two common sense steps to address loopholes that limit competition that permits some drug companies to charge exorbitant prices for generic drugs.

The average wait time for a new generic drug to be approved is nearly four years. In 2014, more than 1,400 generic drug applications were filed and not one was approved. Bera and Peters are asking the FDA to expedite the review process for new generic drugs to increase market competition. Without any competition to drive down prices, a drug company can charge an excessive amount, like in the case of Martin Shkreli and Turing Pharmaceuticals.

The letter also asks the FDA to examine its Unapproved Drugs Initiative in response to concerns that over-regulation has unintentionally increased prices. This initiative aims to ensure that all drugs on the market before FDA regulation are safe, but Bera and Peters are asking that the program focuses on drugs that pose a serious safety risk, citing the fact that the program has pushed common and long-term treatments off the market, leading to price spikes.

“Americans should be able to access quality, affordable prescription medication,” Congressman Bera said. “Competition is critical to maintaining reasonable pricing and the backlog in generic drug applications, as well as the unintended consequences of the Unapproved Drugs Initiative, has created opportunities for some irresponsible drug companies to make a lot of money while Americans suffer. This is not acceptable. We urge the FDA to take these common sense steps to help increase competition and lower drug costs.”

“Making our generic drug approval process faster and more efficient will increase competition and provide consumers with more affordable options,” Congressman Peters said. “This is especially important to the long-term and critically ill who might be taken advantage of by companies like Turing and Valeant who choose to drive up prices because they know these patients don’t have anywhere else to turn for the medicine they need.”

Click here to read the letter.

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