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 HatchLive coverage: Senate GOP unveils its ObamaCare repeal bill Grassley doesn't see how Judiciary 'can avoid' obstruction probe Ryan calls for tax reform to be permanent MORE (R-Utah) and Lamar AlexanderLamar AlexanderThe Hill's Whip List: Senate ObamaCare repeal bill Trump administration pays June ObamaCare subsidies to insurers Republicans and the lost promise of local control in education 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 BurrOvernight Tech: Uber CEO resigns | Trump's Iowa tech trip | Dems push Sessions to block AT&T-Time Warner deal | Lawmakers warned on threat to election systems | Overnight Cybersecurity: Obama DHS chief defends Russian hack response | Trump huddles on grid security | Lawmakers warned about cyber threat to election systems Lawmakers told of growing cyber threat to election systems MORE (R-N.C.), Mike EnziMike EnziBudget committee approves Trump's OMB deputy Senate GOP paves way for ObamaCare repeal bill Senate returns more pessimistic than ever on healthcare MORE (R-Wyo.) and Pat RobertsPat RobertsThe Hill's Whip List: Senate ObamaCare repeal bill Meet Jay Sekulow, the new face of Trump’s legal team Overnight Healthcare: Senate GOP eyes July vote on health bill MORE (R-Kan.) also signed the letter.