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 ask IRS to explain M wasted on unusable email system GOP senators avoid Trump questions on rigged election Schumer says Pacific trade pact may have enough votes to pass the Senate MORE (R-Utah) and Lamar AlexanderLamar AlexanderObama meets a crossroads for his healthcare law Music streamer Spotify joins Gillibrand’s push for paid family leave GOP senators avoid Trump questions on rigged election MORE (R-Tenn.) wrote in a letter to Health and Human Services Secretary Sylvia BurwellSylvia Mathews BurwellHHS projects 13.8M ObamaCare signups for 2017 Republicans demand documents from insurers on ObamaCare 'bailout' Top health officials: Funding delay hurt Zika response 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 BurrPoll: Trump, Clinton in close race in North Carolina The Trail 2016: The grand finale Greens put M into NC Senate race MORE (R-N.C.), Mike EnziMike EnziGOP senators avoid Trump questions on rigged election Report: Feds spend billions on PR Restive GOP freshmen eye entitlement reform MORE (R-Wyo.) and Pat RobertsPat RobertsGOP senators avoid Trump questions on rigged election More Senate Republicans pressure Treasury over debt-equity rules GOP leaders advise members to proceed with caution on Trump MORE (R-Kan.) also signed the letter.