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Flores, Hatch, Tillis Introduce Bicameral Hatch-Waxman Integrity Act

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WASHINGTON, D.C. , December 11, 2018 | Andre Castro (202-225-6105) | comments

U.S. Representative Bill Flores (R-TX), Senator Orrin Hatch (R-UT) and Senator Thom Tillis (R-NC) released the following statements after introducing the Hatch-Waxman Integrity Act of 2018 in the House of Representatives and Senate. The legislation would help ensure that alternative procedures for challenging drug patents do not tilt the playing field contrary to Hatch-Waxman’s design. It would also help make sure that drug manufacturers have the proper incentives to develop life-saving medications.

"The Hatch-Waxman Integrity Act ensures that America remains a leader in developing life-saving and accessible therapies, cures and treatments for patients,said Flores. "It restores an effective balance between the interests of brand-name and generic drug manufacturers so that innovation and competition will continue to flourish.  It is fulfilling to work with Senator Hatch to modernize the Hatch-Waxman Act so that hardworking American families continue to benefit from health care innovation."

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As the coauthor and namesake of Hatch-Waxman, I have a keen interest in ensuring we have a well-functioning generic drug industry," said Hatch. "This means making sure that generic companies are able to develop drugs while also ensuring that brand companies have sufficient protections in place to recoup their investments. Hatch-Waxman struck a careful balance that achieved these goals and in doing so helped to create the modern generic drug industry. The Hatch-Waxman Integrity Act, which I’m pleased to be introducing today with Senator Tillis and Representative Flores, will help preserve that careful balance going by ensuring that newer, alternative procedures for challenging drug patents do not give one side an unintended advantage."

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The biotechnology and life sciences industry undertakes tremendous risk and costs to develop new, life-saving drugs, with the vast majority of products never making it to the market at great expense to the manufacturer. These drugs save millions of lives every year and are a critical component of our nation’s healthcare system. While it is important to call out bad actors who price gouge, we must allow sufficient time and balance so companies can continue to develop life-saving drugs and help people with the countless illnesses and diseases that affect millions of Americans,said Tillis. "The Hatch-Waxman Integrity Act of 2018 will restore a proper balance in the market so that companies will continue to spend billions of dollars to develop life-saving and life-altering treatments. I want to thank Senator Hatch for his leadership on this issue and I look forward to building support for this bill within the Senate."


Background
The Hatch-Waxman Integrity Act of 2018 would require a generic manufacturer wishing to challenge a brand-name drug patent to choose between the Hatch-Waxman framework, which affords certain advantages such as being able to rely on the drug innovator’s safety and efficacy studies for FDA approval, and inter partes review, or IPR, which is cheaper and faster than Hatch-Waxman litigation but does not provide the advantages of a streamlined generic approval process. The bill would apply similarly to patents on biologics.

The bill would preserve Hatch-Waxman as the standard path for generic manufacturers to challenge brand patents, while keeping IPR as an option where other interests come into play. It would not have any impact on the use of IPR by the tech community.

A copy of the bill text is available HERE. A detailed summary of the bill is available HERE.

 

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June 19, 2020 Juneteenth, also known as Freedom Day, Jubilee Day, and Liberation Day, is an unofficial American holiday and an official Texas state holiday, celebrated annually on the 19th of June in the United States to commemorate Union army general Gordon Granger's reading of federal orders in the city of Galveston, Texas, on 19 June 1865, proclaiming all slaves in Texas were now free. Slavery had legally ended in 1863 but wasn’t announced in Galveston until 1865. Background of African Americans and Texas Politics Did you Know? • The Republican Party was formed in 1854 after the Democrats voted to protect and to extend slavery. • The 1860 Democrat platform declared its support for the Supreme Court’s infamous Dred Scott decision. • The 13th Amendment passed without a single Democrat vote in Congress for civil rights for African Americans. • The Republican Party of Texas emerged in Houston on July 4, 1867 with 150 African Americans and 20 Anglos. The same year, the Ku Klux Klan actively began to attack African Americans and Republicans. • Two of the first three statewide leaders of the Republican Party of Texas were African Americans. • The first 42 African Americans elected to the Texas Legislature were all Republicans. • From 1865-1869, Texas Democrats passed “Black Codes” to prohibit African Americans from voting, holding office, and serving on juries. They also refused to acknowledge Juneteenth and even drafted a new State constitution requiring that State Representatives and Senators only be “of the white race.” • When the Republicans gained the Texas Legislature in 1869, they established a system of free public schools to educate all the children of the State (something Democrats had refused to do) and started a Texas State Militia and a Texas State police in which African Americans proudly served. • When Democrats recaptured Texas government in 1872, Democrat Governor Richard Coke’s election was described as “the restoration of white supremacy and Democratic rule.” • Texas Democrats engaged in bizarre gerrymandering specifically to prevent African American members from being re-elected to the Legislature. When African American Republican legislator Robert L. Smith departed in 1897, no African American was elected in Texas until 1966, when the U.S. Supreme Court ordered Texas Democrats to redraw districts. • Texas Democrats enacted a poll tax that reduced African American voter turnout in Texas from 100,000 to only 5,000 and passed white-only primary laws as well as Jim Crow segregation laws. • As victims of Democrat racism and segregation, African Americans were loyal to the Republican Party they started. In fact, Republican President Herbert Hoover received more than three-fourths of the African American vote over his Democratic challenger Franklin D. Roosevelt. • Republican President Dwight D. Eisenhower was the first president to appoint an African American to an executive position on the White House staff. • A higher percentage of Republican Members of Congress voted for the Civil Rights Act of 1964 and the Voting Rights Act of 1965 than did Democrats. • African Americans made their most significant political and civil rights progress while affiliated with the Republican Party. Happy Juneteenth!

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Yesterday I testified before the @China_TaskForce about H.R. 6885, a bill I introduced to move our pharmaceutical s… https://t.co/wgUUimUOzg