Monthly Archives: August 2018

The official blog of Team Bilirakis. Featuring the latest news and updates from the campaign trail. Check back frequently or sign up for updates.

Gus Bilirakis’ efforts paving the way for cheaper EpiPens

Florida Politics

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The Food and Drug Administration announced last week that it had approved the first generic EpiPen, and those saving cash on the lifesaving drug can thank U.S. Rep. Gus Bilirakis for the legislation that allowed regulators to inject some competition into the market.

Bilirakis, a Tarpon Springs Republican, was able to get multiple provisions into the FDA Reauthorization Act of 2017 (H. R. 2430) which was passed by Congress and signed into law a year ago. Among those provisions: An expedited approval process for generic drugs when no competitor exists on the market.

Bilirakis’ language allowed the FDA to approve a generic version of the Mylan-produced EpiPen, an epinephrine auto-injector that provides fast relief to those suffering from an intense allergic reaction known as anaphylaxis.

Mylan had come under fire in recent years for raising the price of EpiPens from $100 to more than $600 a pack since it acquired the rights to the drug in 2007. The company has also finalized a $465 million settlement for overcharging the government for EpiPens.

“Too often we have seen the price of lifesaving medication skyrocket due to bad actors taking advantage of monopolies in the market. The dramatic spike in cost for medications, like the EpiPen, prompted me to push for these critical reforms,” Bilirakis said in a news release.

“Sick people should never be held hostage so a pharmaceutical company can increase its profits. I am thrilled that my legislative efforts are already translating into lower costs for patients and look forward to seeing the reduction of cost for many more Rx drugs,” he concluded

Teva Pharmaceuticals USA was approved to market the generic auto-injector, though the company has not specified a price or release date for the drug.

“We’re applying our full resources to this important launch in the coming months and eager to begin supplying the market,” the company announced last week.

Gus Bilirakis Scores a Win as FDA Approves Generic EpiPen

News Talk Florida

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The U.S. Food and Drug Administration (FDA) is backing a proposal from a Florida congressman for a generic EpiPen.

Back at the start of last year, U.S. Rep. 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 FDA announced it was approving a generic EpiPen last week.

“Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. as part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval,” said FDA Commissioner Scott Gottlieb on Thursday.

“This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages,” Gottlieb added. “The path to developing generic drug-device combination products like this one is challenging. We remain committed to doing our part to provide scientific and regulatory clarity for sponsors seeking to develop complex generics, as well as prioritize the approval of medicines with little or no generic competition as part of our overarching effort to remove barriers to generic development and market entry of critically important medicines. Many of these steps were outlined in our Drug Competition Action Plan, announced last year. We’re especially committed to the development of generic copies of complex products. These products can be hard to copy, and therefore sometimes don’t face timely generic competition once patents and exclusivities are no longer a block to approval. We’re advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we’re prioritizing review of many complex generic drug applications.”

Bilirakis’ office noted that the Florida congressman’s proposal “reformed the FDA Office of Combination Products as a result of this exchange with FDA officials” and noted the Office of Combination Products “manages the approval of Complex drug-device combination products (e.g., auto-injectors, metered dose inhalers).

“The EpiPen, a life-saving drug for millions of Americans, is an example of a combination product,” Bilirakis’ office noted. “The company that manufacturers the EpiPen, Mylan Pharmaceuticals raised the cost of the EpiPen by 400 percent, making it unaffordable for many families. Traditionally, there has not been a generic version of the EpiPen available on the market. However, thanks to the reforms championed by Bilirakis, the FDA just announced that it has approved the first generic version of the EpiPen, used to treat allergic reactions.”

The congressman weighed in on the FDA’s decision on Monday morning.

“Too often we have seen the price of lifesaving medication skyrocket due to bad actors taking advantage of monopolies in the market,” Bilirakis said. “The dramatic spike in cost for medications, like the EpiPen, prompted me to push for these critical reforms. Sick people should never be held hostage so a pharmaceutical company can increase its’ profits. I am thrilled that my legislative efforts are already translating into lower costs for patients and look forward to seeing the reduction of cost for many more Rx drugs.”

Earlier this month, the FDA announced it was approving the first 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.”

BUSINESS GROUP ENDORSES BILIRAKIS

Tampa Bay Reporter

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U.S. Rep. Gus Bilirakis is running for reelection to District 12 in the U.S. House of Representatives.

TALLAHASSEE – The Associated Industries of Florida board of directors has endorsed Gus Bilirakis, who is running for his seventh term in the U.S. House of Representatives.

Bilirakis was one of16 Congressional candidates from across Florida that the AIF endorsed Thursday (Aug. 2).

“Today, the AIF Board of Directors is proud to release our endorsements for those candidates here in Florida that we believe will best serve Florida businesses and families in the U.S. House of Representatives,” AIF President and CEO Tom Feeney said.  “We believe these individuals are the most qualified candidates in their respective races to take our pro-growth, pro-job and free-enterprise message to Washington to continue to make Florida a top state in the nation to live, work and raise a family.”

Feeney added, “We strongly encourage our fellow Floridians to vote to send these candidates to Washington to fight for Florida. Our businesses and families can count on these individuals to foster a business-friendly environment our future generations can rely on.”  

Known as “the Voice of Florida Business” in the Sunshine State, the AIF has represented the principles of prosperity and free enterprise before the three branches of state government since 1920. A voluntary association of diversified businesses, AIF was created to foster an economic climate in Florida conducive to the growth, development, and welfare of industry and business and the people of the state.

Bilirakis was first elected to Congress in 2007. He currently serves on the Energy and Commerce Committee and is vice-chair of the House Committee of Veterans’€™ Affairs.

Bilirakis said he works in a bipartisan manner to control federal spending, create jobs for middle class Americans, lower taxes, and seeks ways to make government smaller and more efficient. He said he is committed to strengthening homeland security, improving education, increasing access to quality health care, protecting veterans’€™ benefits, and ensuring the long-term viability of Social Security and Medicare.

Bilirakis represents Florida’s 12th Congressional District, which includes all of Pasco County and the northern portions of Pinellas and Hillsborough counties.

Bilirakis, a Repubican, has no opposition in the Aug. 28 primary. In the Nov. 6 general election, he will face the winner of the Democratic primary and Angelika Purkis, who has no party affiliation.