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Schrader Law to Lower Drug Costs Produces Success in the Generics Market

The bipartisan Schrader law will give more treatment options to those suffering hypokalemia.

The FDA this week announced the first generic drugs to receive a Competitive Generic Therapy (CGT) designation – a classification established under a bipartisan Schrader bill that became law last year – which allows generics with few to no alternatives to come to market faster. The drugs to receive the CGT designation include several strengths of potassium chloride oral solution, used to treat hypokalemia, or low potassium blood levels, in patients who are on diuretics, that currently do not have generic versions available.

“We’ve seen some lifesaving drugs become astronomically expensive in recent years, sometimes overnight and often with zero explanation. Working on solutions to bring down drug costs has been a top priority of mine,” said Rep. Schrader. “I’m very pleased to announce the first success as a result of my bipartisan legislation to lower drug costs that became law last year. We know that having generic versions of medication on the market stimulates competition and keeps the cost of drugs down for everyone. Thanks to the new CGT status, established by my law, folks suffering from low potassium blood levels will now have more treatment options available to them, keeping a check on the market and preventing unaccountable price hikes to these drugs from occurring. This is also a prime example of the direct impact Congress can have when we work together on solutions to the problems our constituents face back at home.”

Congressman Kurt Schrader’s legislation, a version of which he introduced in January 2017, moved through the House and Senate with unanimous support before becoming law in August, 2017. Congressman Schrader began his bipartisan charge to bring down drug costs in the 114th Congress when he first introduced a version of the legislation in response to the dramatic 4,000 percent overnight price hike on the life-saving drug Daraprim. Dozens more competitive generic therapies are currently in the pipeline awaiting FDA action, boding potential for more competition coming to market.

The Schrader law increases competition among new generic drugs competing with off-patent brand drugs where there is no competition by:

  • Requiring greater communication between the FDA and manufacturers for these competitive generic products before and during the application process which guarantees an accelerated eight month review;
  • Creating incentive to come to market by guaranteeing the same six months of exclusivity that the vast majority of first generic drugs currently receive;
  • Closing a loophole and improving program integrity in the Tropical Disease priority review voucher program.