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 HatchTreasury officials to meet with lawmakers on inversion rules A bipartisan bright spot we can’t afford to pass up: child welfare reform Medicare trust fund running out of money fast MORE (R-Utah) and Lamar AlexanderLamar AlexanderVeep auditions in overdrive Senators press Obama education chief on reforms Senate honors Tennessee coach Pat Summitt MORE (R-Tenn.) wrote in a letter to Health and Human Services Secretary Sylvia BurwellSylvia Mathews BurwellHHS launches contest to make bills simpler Obama administration takes step to reform Medicare payments Rubio breaks with GOP, backs Obama Zika request 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 BurrGingrich, Christie top Trump’s VP list: report Homeland Security Committee pushes encryption commission in new report Clinton endorses Warner-McCaul encryption commission MORE (R-N.C.), Mike EnziMike EnziJudd Gregg: The silver lining Judd Gregg: A little change Lobbying World MORE (R-Wyo.) and Pat RobertsPat RobertsWhat Senate backers aren’t saying about the GMO “compromise” bill Overnight Regulation: FDA raises concerns over GMO labeling bill FDA concerned with GMO labeling 'compromise' MORE (R-Kan.) also signed the letter.