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 HatchOvernight Finance: NAFTA defenders dig in | Tech pushes Treasury to fight EU on taxes | AT&T faces setback in merger trial | Dems make new case against Trump tax law | Trump fuels fight over gas tax What sort of senator will Mitt Romney be? Not a backbencher, even day one Lawmaker interest in NAFTA intensifies amid Trump moves MORE (R-Utah) and Lamar AlexanderAndrew (Lamar) Lamar AlexanderOvernight Health Care: Trump health chief backs CDC research on gun violence | GOP negotiators meet on ObamaCare market fix | Groups sue over cuts to teen pregnancy program GOP negotiators meet on ObamaCare market fix 30 million people will experience eating disorders — the CDC needs to help MORE (R-Tenn.) wrote in a letter to Health and Human Services Secretary Sylvia BurwellSylvia Mary 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 BurrOvernight Finance: Senate rejects Trump immigration plan | U.S. Bancorp to pay 0M in fines for lacking money laundering protections | Cryptocurrency market overcharges users | Prudential fights to loosen oversight Senators introduce bill to help businesses with trade complaints Our intelligence chiefs just want to tell the truth about national security MORE (R-N.C.), Mike EnziMichael (Mike) Bradley EnziThe 14 GOP senators who voted against Trump’s immigration framework Mulvaney remarks on Trump budget plan spark confusion Overnight Finance: Breaking down Trump's budget | White House finally releases infrastructure plan | Why it faces a tough road ahead | GOP, Dems feud over tax-cut aftermath | Markets rebound MORE (R-Wyo.) and Pat RobertsCharles (Pat) Patrick RobertsOvernight Finance: Lawmakers, Treasury look to close tax law loopholes | Trump says he backs gas tax hike | Markets rise despite higher inflation | Fannie Mae asks for .7B Senators working on fix to agriculture provision in GOP tax law Trump budget would slash crop insurance funds for farmers MORE (R-Kan.) also signed the letter.