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 HatchOn The Money — Sponsored by Prudential — Senators hammers Ross on Trump tariffs | EU levies tariffs on US goods | Senate rejects Trump plan to claw back spending Senators hammer Ross over Trump tariffs Top Finance Dem wants panel to investigate Trump Foundation MORE (R-Utah) and Lamar AlexanderAndrew (Lamar) Lamar AlexanderOn The Money — Sponsored by Prudential — Supreme Court allows states to collect sales taxes from online retailers | Judge finds consumer bureau structure unconstitutional | Banks clear Fed stress tests Supreme Court rules states can require online sellers to collect sales tax 13 GOP senators ask administration to pause separation of immigrant families 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 BurrHillicon Valley: New FTC chief eyes shake up of tech regulation | Lawmakers target Google, Huawei partnership | Microsoft employees voice anger over ICE contract On The Money — Sponsored by Prudential — Senators hammers Ross on Trump tariffs | EU levies tariffs on US goods | Senate rejects Trump plan to claw back spending Senate Intel requests more testimony from Comey, McCabe MORE (R-N.C.), Mike EnziMichael (Mike) Bradley EnziHouse panel to mark up 2019 budget Overnight Defense: Top general defends Afghan war progress | VA shuffles leadership | Pacific Command gets new leader, name | Pentagon sued over HIV policy Senate GOP urges Trump administration to work closely with Congress on NAFTA MORE (R-Wyo.) and Pat RobertsCharles (Pat) Patrick RobertsModerates need to hold firm against radical right on Farm Bill GOP senators introduce bill to prevent family separations at border Senate GOP tries to defuse Trump border crisis MORE (R-Kan.) also signed the letter.