GOP senators press for generic vaccines

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 Grant HatchKoch groups: Don't renew expired tax breaks in government funding bill Hatch tweets link to 'invisible' glasses after getting spotted removing pair that wasn't there DHS giving ‘active defense’ cyber tools to private sector, secretary says MORE (R-Utah) and Lamar AlexanderAndrew (Lamar) Lamar AlexanderWeek ahead: Lawmakers near deal on children's health funding Ryan suggests room for bipartisanship on ObamaCare Time to end fiscal year foolishness MORE (R-Tenn.) wrote in a letter to Health and Human Services Secretary Sylvia BurwellSylvia Mathews BurwellPrice was a disaster for HHS — Time for an administrator, not an ideologue Overnight Healthcare: GOP chairman to introduce pre-existing condition bill ObamaCare enrollment hits 11.5M 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 Mauze BurrNSA spying program overcomes key Senate hurdle Senate Intel chairman: No need for committee to interview Bannon McConnell: Russia probe must stay bipartisan to be credible MORE (R-N.C.), Mike EnziMichael (Mike) Bradley EnziGOP is addressing tax cuts and a pension bill that could help coal miners Overnight Finance: Congress sends Trump funding bill to avert shutdown | WH sees 'tentative' deal on defense spending | GOP discovers corporate tax snag | Consumer bureau fight heats up | Apple could see B windfall from tax bill Overnight Finance: Congress sends Trump bill to avert shutdown | GOP discovers corporate tax snag | CFPB leadership battle rages MORE (R-Wyo.) and Pat RobertsCharles (Pat) Patrick RobertsGOP senators eager for Romney to join them Canada tamps down worries about US NAFTA withdrawal Canada worried Trump will withdraw from NAFTA: report MORE (R-Kan.) also signed the letter.