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 HatchTrump to award racing legend Roger Penske with Presidential Medal of Freedom Trump awards Presidential Medal of Freedom to economist, former Reagan adviser Arthur Laffer Second ex-Senate staffer charged in aiding doxxing of GOP senators MORE (R-Utah) and Lamar AlexanderAndrew (Lamar) Lamar AlexanderHere are the lawmakers who aren't seeking reelection in 2020 EXCLUSIVE: Swing-state voters oppose 'surprise' medical bill legislation, Trump pollster warns The 13 Republicans needed to pass gun-control legislation MORE (R-Tenn.) wrote in a letter to Health and Human Services Secretary Sylvia BurwellSylvia Mary Mathews BurwellWhy Trump will win the wall fight Price was a disaster for HHS — Time for an administrator, not an ideologue Overnight Healthcare: GOP chairman to introduce pre-existing condition bill 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 BurrLawmakers applaud Trump's ban on flavored e-cigarettes Trump to hold campaign rally in North Carolina day before special House election Hoekstra emerges as favorite for top intelligence post MORE (R-N.C.), Mike EnziMichael (Mike) Bradley EnziHere are the lawmakers who aren't seeking reelection in 2020 Liz Cheney and Rand Paul extend war of words The Hill's Morning Report - 2020 Democrats set for Lone Star showdown MORE (R-Wyo.) and Pat RobertsCharles (Pat) Patrick RobertsInternal poll shows Kobach trailing Democrat in Kansas Senate race Here are the lawmakers who aren't seeking reelection in 2020 Hillicon Valley: Lawmakers ramp up Silicon Valley antitrust probe | Treasury sanctions North Korean cyber groups | Thiel to host Kobach fundraiser MORE (R-Kan.) also signed the letter.