By Ferdous Al-Faruque - 08/01/14 05:19 PM EDT
Republican senators are calling on the Department of Health and Human Services to release documents that would let the medical industry bring generic vaccines and tissue products to market.
Medical products made from living cells such as vaccines and skin grafts are known as biologics, and their generic versions are called biosimilars.
“The [Food and Drug Administration] has not yet issued guidance on some of the key scientific policy questions related to biosimilars, such as naming, labeling, indication extrapolation, and interchangeability,” Sens. Orrin HatchOrrin HatchHow the White House got rolled on the Saudi-9/11 bill Overnight Finance: Lawmakers float criminal charges for Wells Fargo chief | Scrutiny on Trump's Cuba dealings | Ryan warns of recession if no tax reform Overnight Healthcare: Watchdog says ObamaCare program made illegal payments MORE (R-Utah) and Lamar AlexanderLamar AlexanderMcConnell: Cures bill a 'top priority' in lame-duck Lawmakers pledge push for cures bill in lame-duck Overnight Regulation: Lawsuits pile up against Obama overtime rule MORE (R-Tenn.) wrote in a letter to Health and Human Services Secretary Sylvia BurwellSylvia Mathews BurwellOvernight Healthcare: McConnell unveils new Zika package | Manchin defends daughter on EpiPens | Bill includes M for opioid crisis Insurance executives ask for changes to ObamaCare Obama meets with insurance CEOs on health law MORE.
“We urge you and those within your Department to immediately release guidance pending within the HHS related to the implementation of the biosimilar pathway,” they added.
Biosimilars have been in wide use in Europe and according to Express Scripts, the largest pharmacy benefit management company, their wider use could save the U.S. healthcare system more than $250 billion in the next few years.
Last week the FDA said it was reviewing Sandoz’s biosimilar Zarzio, which could reduce infections in cancer patients. If approved, it would be the first biosimilar to hit the U.S. market and open the floodgates for similar products.
“We assume that FDA and Sandoz had conversations about key issues … and that the FDA is engaged in conversations with other manufacturers who intend to file biosimilar applications in the future,” the two GOP lawmakers wrote.
They noted the FDA is required to release guidance to industry under the 2010 Biologics Price Competition and Innovation Act (BPCIA) but has yet to do so.
“These meetings should not be the only or primary means by which BPCIA implementation policies are developed,” they added. “Does the FDA intend to approve the first biosimilar before policies on these key scientific questions are publicly released?”
Sens. Richard BurrRichard BurrDem groups invest big in Bayh in Ind. Senate race The Trail 2016: Fight night Poll finds races for president, Senate tight in North Carolina MORE (R-N.C.), Mike EnziMike EnziOvernight Energy: Obama integrates climate change into national security planning Senate panel approves pension rescue for coal miners GOP pressures Kerry on Russia's use of Iranian airbase MORE (R-Wyo.) and Pat RobertsPat RobertsGOP senators ask watchdog to examine Gitmo site surveys spending Senate panel approves pension rescue for coal miners Congress set for Saudi showdown with Obama MORE (R-Kan.) also signed the letter.