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 HatchTen senators ask FCC to delay box plan An affordable housing solution both parties can get behind Puerto Rico debt relief faces serious challenges in Senate MORE (R-Utah) and Lamar AlexanderLamar AlexanderSenate backs equal pay for female soccer players Overnight Healthcare: Momentum on mental health? | Zika bills head to conference | Only 10 ObamaCare co-ops left Overnight Regulation: GOP slams new Obama education rules 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 BurrThe Trail 2016: Hell breaks loose Burr, Ross in statistical dead heat in NC Senate race Senate panel advances spy policy bill, after House approves its own version MORE (R-N.C.), Mike EnziMike EnziGOP blocks slate of Obama judicial nominees Overnight Finance: New rules proposed to curb Wall Street pay GOP senator tries to tie 'No budget, no pay' to funding bill MORE (R-Wyo.) and Pat RobertsPat RobertsGOP senators propose sending ISIS fighters to Gitmo Passing the Kelsey Smith Act will help law enforcement save lives Overnight Defense: VA chief 'deeply' regrets Disney remark; Senate fight brews over Gitmo MORE (R-Kan.) also signed the letter.