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 HatchGOP lawmakers call for overhaul of proposed corporate tax rules DEA decision against reclassifying marijuana ignores public opinion Trump op-ed counters Clinton’s pitch to Utah voters MORE (R-Utah) and Lamar AlexanderLamar AlexanderTenn. senator blasts 'intolerable increase' in ObamaCare prices GOP Rep. Black wins primary fight GOP senators to donors: Stick with us regardless of Trump MORE (R-Tenn.) wrote in a letter to Health and Human Services Secretary Sylvia BurwellSylvia Mathews BurwellUS declares 'public health emergency' in Puerto Rico over Zika Administration shifts funds to boost Zika vaccine work Health chief warns Congress: Zika funds quickly running out 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 BurrSenate Dems' campaign arm knocks GOP for Trump support NC poll: Clinton up 2 points over Trump France, Germany push for encryption limits MORE (R-N.C.), Mike EnziMike EnziLiz Cheney wins Wyoming House primary Liz Cheney expected to cruise through Tuesday primary Sanford-Enzi 'Penny Plan' gets nation to a balanced budget MORE (R-Wyo.) and Pat RobertsPat RobertsTrump's new agriculture brain trust includes Rick Perry, Jim Gilmore Newer waters, same river: The Louisiana floods, and a state in turmoil Meet the rising GOP star who already enrages the left MORE (R-Kan.) also signed the letter.