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 HatchHatch urged Trump to ‘speak clearly’ against hate groups The Memo: Trump tries to quiet race storm Senators push FTC to finalize changes to contact lens rule MORE (R-Utah) and Lamar AlexanderAndrew (Lamar) Lamar AlexanderTrump to make ObamaCare payments to insurers for August CBO: ObamaCare premiums could rise 20 percent if Trump ends payments CBO to release report Tuesday on ending ObamaCare insurer payments MORE (R-Tenn.) wrote in a letter to Health and Human Services Secretary Sylvia BurwellSylvia Mathews BurwellOvernight Healthcare: GOP chairman to introduce pre-existing condition bill ObamaCare enrollment hits 11.5M for 2017 Obama, Dems eyeing strategy to defend ObamaCare 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 BurrSenate chairman hopes to wrap up Russia investigation this year Lawmakers seek to interview Trump secretary in Russia probe Senate Dem wants closer look at Russia's fake news operation on Facebook MORE (R-N.C.), Mike EnziMike EnziSenate panel might not take up budget until October Debt group urges GOP chairman to avoid budget 'gimmicks' Fiscal hawks call for ‘mini-bargain’ on budget MORE (R-Wyo.) and Pat RobertsPat RobertsNo. 2 Senate Republican backs McConnell in Trump fight Overnight Healthcare: McConnell warns Senate not to block repeal debate | Insurers knock Cruz proposal | WH tries to discredit CBO | Lawmakers propose .1B NIH funding boost Trump: I’ll be ‘very angry’ if Senate doesn’t pass ObamaCare repeal bill MORE (R-Kan.) also signed the letter.