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===Good until May 10, 2019===
by: Kim Schrier (D-WA, 8th)
Washington, D.C. - April 18, 2019 - (The Ponder News) -- As Congress holds hearings about the high cost of insulin, U.S. Representative Kim Schrier, M.D. (WA-08) has introduced a bipartisan bill that will bring down the cost of insulin. Rep. Schrier, a member of the Executive Committee of the Diabetes Caucus who has Type 1 diabetes and is a pediatrician, knows all too well how the price of insulin is affecting families all across the country.
“My insulin has tripled in price in the last 10 years and now costs $260, which is in between the price of Chanel No. 5 and cobra venom,” said Rep. Schrier. “We should be doing everything we can to make more affordable treatments widely available, because right now for too many of my patients and people across the country, the cost of insulin is a life or death issue. This bill paves the way for less expensive versions of brand name insulins.”
In December 2018, the Federal Drug Administration (FDA) issued guidance giving drug makers a pathway for biosimilar approvals. Like a generic drug, biosimilars can use an expedited approval process that doesn’t need to duplicate expensive clinical trials and are often sold at a fraction of the price of brand name drugs. The Protecting Access to Biosimilars Act, introduced by Rep. Schrier with Rep. Diana Degette (D-CO01) and Rep. Tom Reed (R-NY23) and Rep. Brett Guthrie (R-KY-02) would make this FDA guidance law. This is important to do because guidance can be easily revoked, throwing a future market into chaos and affecting people who were taking biosimilar drugs.
Most biologics are approved by the FDA under Section 351 of the Public Health Service Act. A handful of protein-based biologics, including insulin, however, are approved under Section 505 of the Food, Drug, & Cosmetic Act. Drug makers are not able to make biosimilar (generic) versions of drugs approved under Section 505 due to regulatory issues.
The Biologics Price Competition and Innovation Act, enacted as part of the Affordable Care Act, clarified that all protein-based biologics, including insulin, must be approved under Section 351 of the Public Health Service Act starting on March 23, 2020. Drug makers can make biosimilars of biologics approved under Section 351. Biologics that were approved under Section 505 prior to March 23, 2020 would receive a “grandfathered approval” under Section 351. FDA guidance on how drug makers can file biosimilar applications after the law’s implementation date on March 23, 2020 was issued in December.
===Good until May 10, 2019===
by: Kim Schrier (D-WA, 8th)
Washington, D.C. - April 18, 2019 - (The Ponder News) -- As Congress holds hearings about the high cost of insulin, U.S. Representative Kim Schrier, M.D. (WA-08) has introduced a bipartisan bill that will bring down the cost of insulin. Rep. Schrier, a member of the Executive Committee of the Diabetes Caucus who has Type 1 diabetes and is a pediatrician, knows all too well how the price of insulin is affecting families all across the country.
“My insulin has tripled in price in the last 10 years and now costs $260, which is in between the price of Chanel No. 5 and cobra venom,” said Rep. Schrier. “We should be doing everything we can to make more affordable treatments widely available, because right now for too many of my patients and people across the country, the cost of insulin is a life or death issue. This bill paves the way for less expensive versions of brand name insulins.”
In December 2018, the Federal Drug Administration (FDA) issued guidance giving drug makers a pathway for biosimilar approvals. Like a generic drug, biosimilars can use an expedited approval process that doesn’t need to duplicate expensive clinical trials and are often sold at a fraction of the price of brand name drugs. The Protecting Access to Biosimilars Act, introduced by Rep. Schrier with Rep. Diana Degette (D-CO01) and Rep. Tom Reed (R-NY23) and Rep. Brett Guthrie (R-KY-02) would make this FDA guidance law. This is important to do because guidance can be easily revoked, throwing a future market into chaos and affecting people who were taking biosimilar drugs.
Most biologics are approved by the FDA under Section 351 of the Public Health Service Act. A handful of protein-based biologics, including insulin, however, are approved under Section 505 of the Food, Drug, & Cosmetic Act. Drug makers are not able to make biosimilar (generic) versions of drugs approved under Section 505 due to regulatory issues.
The Biologics Price Competition and Innovation Act, enacted as part of the Affordable Care Act, clarified that all protein-based biologics, including insulin, must be approved under Section 351 of the Public Health Service Act starting on March 23, 2020. Drug makers can make biosimilars of biologics approved under Section 351. Biologics that were approved under Section 505 prior to March 23, 2020 would receive a “grandfathered approval” under Section 351. FDA guidance on how drug makers can file biosimilar applications after the law’s implementation date on March 23, 2020 was issued in December.
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