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 HatchSenate GOP: National museum should include Clarence Thomas Mnuchin's former bank comes under scrutiny Trump’s economic team taking shape MORE (R-Utah) and Lamar AlexanderLamar AlexanderMedicare looms over Trump-Ryan alliance This week: Government funding deadline looms Key Republicans ask Trump to keep on NIH director MORE (R-Tenn.) wrote in a letter to Health and Human Services Secretary Sylvia BurwellSylvia Mathews BurwellObamaCare demonstrates dangers of government interference FDA’s hostility blocks Zika-prevention technology HHS projects 13.8M ObamaCare signups for 2017 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 BurrTop Intel Dem: Congress 'far from consensus' on encryption Trump must be an advocate for the Small Business Administration Dems pledge to fight Sessions nomination MORE (R-N.C.), Mike EnziMike EnziSenate Dems draw hard line over miners' pension bill Republicans want to grease tracks for Trump President-elect Trump: Please drain the student loan swamp MORE (R-Wyo.) and Pat RobertsPat RobertsSenate GOP to Obama: Stop issuing new rules GOP debates going big on tax reform Memo to the LGBT community: Donald Trump is not your enemy MORE (R-Kan.) also signed the letter.