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 HatchFive things to watch in round 2 of Trump confirmation fights Dems push for outside witnesses at Mnuchin hearing Live coverage: The Senate's 'vote-a-rama' MORE (R-Utah) and Lamar AlexanderLamar AlexanderWeek ahead: Trump nominees brace for round two of hearings Trump education pick to face Warren, Sanders 9 GOP senators Trump must watch out for MORE (R-Tenn.) wrote in a letter to Health and Human Services Secretary Sylvia BurwellSylvia Mathews BurwellObamaCare enrollment hits 11.5M for 2017 Obama, Dems eyeing strategy to defend ObamaCare 6.4M people sign up for ObamaCare so far 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 BurrTrump education pick to face Warren, Sanders Senate Intel panel to probe Trump team's ties to Russia Trump's CIA nominee seeks to calm nerves MORE (R-N.C.), Mike EnziMike EnziSchumer puts GOP on notice over ObamaCare repeal Live coverage: The Senate's 'vote-a-rama' Senate heading toward late-night marathon session MORE (R-Wyo.) and Pat RobertsPat RobertsFive questions for Trump’s tax reform Who are the real champions for children? Senate GOP to Obama: Stop issuing new rules MORE (R-Kan.) also signed the letter.