Gus Bilirakis’ Effort to Expand Generic Drug Manufacturing Pays Off

By KEVIN DERBY Sunshine State News


Back at the start of last year, local Congressman Gus Bilirakis, R-Fla., teamed up with U.S. Rep. Kurt Schrader, D-Oreg., to bring out the “Lower Drug Costs Through Competition Act” which they insisted “will incentivize drug makers to develop generic drugs when competition currently does not exist, or when there is a drug shortage.”

The congressmen noted that there is often little incentive to develop generic drugs, pointing to the high-profile story back in 2015 when Martin Shkreli raised the price of Daraprim from $13.50 to $750.

“In this instance, there was no generic on the market at the time of the disproportionate price hikes,” Bilirakis’ office noted about the Daraprim price hike. “This bill incentivizes companies to develop these generic drugs by creating a new Priority Review Voucher for generic drugs. The voucher would be awarded to manufacturers that bring a drug to market where there is no current competition.”

The bill passed and was signed into law and, this week, the Food an Drug Administration (FDA) approved the first medication allowed by Bilirakis’ law.

“The U.S. Food and Drug Administration today approved several strengths of potassium chloride oral solution as the first generic drugs to receive a Competitive Generic Therapy (CGT) designation,” the FDA announced on Wednesday. “This new approval pathway was created to expedite the development and review of a generic drug for products that lack competition. Potassium chloride is an oral treatment that is indicated for the treatment and prevention of hypokalemia (low potassium blood levels) in patients who are on diuretics, and when dietary management with potassium-rich foods is insufficient or diuretic dose reduction is not possible.”

“Today’s approval marks the successful implementation of a new program designed to encourage generic drug development for products with inadequate generic competition,” said FDA Commissioner Dr. Scott Gottlieb. “The quick implementation of this new pathway is part of our broader effort to foster generic competition and help address the high cost of drugs. So are our efforts to narrow the time it takes for generic drugs to reach the market by reducing the number of review cycles that generic applications typically undergo. This new generic drug application was also approved in its first cycle of review. This approval demonstrates that the competitive generic therapy pathway is efficient and open for business. This pathway is a key step in making safe and effective generic drugs available to patients quickly and ensuring there’s adequate competition so patients have affordable access to the treatments they need.”

Bilirakis weighed in on the development on Thursday.

“Too often we have seen the price of lifesaving medication skyrocket due to bad actors taking advantage of monopolies in the market,” he said.” We witnessed it in 2015,  when Turing Pharmaceuticals hiked the price of Daraprim, a drug to treat HIV patients. And, we saw it again with Mylan Pharmaceuticals raising the cost of the EpiPen by 400 percent. We cannot allow this to continue.  Sick people should never be held hostage so a pharmaceutical company can increase its’ profits.’

“There is no question that the rising cost of prescription drugs has created a real hardship for most Americans, which is why I have taken an active role in trying to solve the problem.  I am thrilled that my legislative efforts have resulted in this breakthrough! But I also recognize that this is only part of the solution, which is why I’m working through my role on the Health Subcommittee on other measures to reduce costs,”  Bilirakis added.