On The Hill
Health Update (February 25)
With the House and Senate both out for recess this week, there wasn’t much movement on Capitol Hill. Things look to pick up next week with HHS Secretary Alex Azar’s multiple testimonies in front of Congressional Committees on HHS’s FY 2021 Budget. Sen. Chuck Grassley (R-IA)’s drug pricing legislation (S. 2543) is gaining traction as fellow Iowan Sen. Joni Ernst (R-IA) became the 12th Senate Republican to voice support for the bill. Additionally, the Food and Drug Administration (FDA) hired two new advisors to Commissioner Stephen Hahn and also issued a final definition of the term “biological product” — an action the agency says should make it easier to get cheaper insulin on the market.
Drug Pricing Legislation
Sen. Joni Ernst (R-IA) is the latest Republican to support the bipartisan drug pricing legislation (S. 2543) by Sen. Chuck Grassley (R-IA), bringing the number of Senate Republicans who support the bill to 12.
Grassley said he needs support from at least 25 GOP senators to convince Senate Majority Leader Mitch McConnell (R-KY) to bring S. 2543 to the floor. Despite the expressions of support, the bill has no co-sponsors.
Ernst also endorsed a competing drug pricing bill from a group of Senate Finance Republicans led by Mike Crapo (R-ID).
The list of Republican Senators in support of the bill is: Chuck Grassley (IA), Joni Ernst (IA), Rob Portman (OH), John Cornyn (TX), Todd Young (IN), Steve Daines (MT), Bill Cassidy (LA), Lisa Murkowski (AK), Susan Collins (ME), Kevin Cramer (ND), Mike Braun (IN), and Martha McSally (AZ).
A Grassley spokesperson said they expect to announce several new GOP endorsements in the coming weeks. [1]
FDA
“Biological Product” Redefined
This week, the FDA issued a final definition of the term “biological product” — an action the agency says should make it easier to get cheaper insulin on the market. Critics say this might mean slower licensing of lower-cost drugs in the future.
The rule lines up FDA’s policies with a 2019 spending bill in which Congress inserted language to reclassify “chemically synthesized polypeptides” as biological products instead of small molecule drugs.
The Affordable Care Act (ACA) had defined a biological product as a protein other than a chemically synthesized polypeptide, which left uncertainty about the status of insulin and some other drugs. FDA Commissioner Stephen Hahn said the final rule would open new pathways for manufacturers to market biosimilar and interchangeable versions of drugs such as insulin. This could bring down prices, he said in a news release.
In addition to insulin, an FDA Q&A document notes that growth hormones in certain fertility drugs and others would be regulated as biologics beginning on March 23. FDA has argued that the generic drug pathway is not designed to enable copycat applications for complex proteins such as insulin, where generic versions may not be identical to the original.
But while the rule change could make it easier to market copycat insulin and other drugs whose market exclusivity has long expired, it will now take longer to get copies of new complex drugs on the market. Makers of biological products will have 12 years of exclusive marketing rights, compared with five years of exclusivity for small molecule drugs. [2]
FDA Adds Two Advisors
Jeet Guram, a Senior Advisor to CMS Administrator Seema Verma and University of California, San Francisco Professor Tim Solberg were added as two of FDA Commissioner Stephen Hahn’s new advisers.
Guram will assist with drug and tobacco related issues, while Solberg will look to focus on medical-device issues. [3]
2020 Economic Report
This week, the White House released their 2020 Economic Report.
A link to the full report can be found here.
References
[1] Cohen, Ariel. “Ernst is 12th Republican to Support Grassley – Wyden Drug Pricing Bill.” Inside Health Policy. 18 Feb. 2020. https://insidehealthpolicy.com/daily-news/ernst-12th-republican-support-grassley-wyden-drug-pricing-bill
[2] Allen, Arthur. “FDA redefines ‘biological product’ in final rule.” Politico Pro. 20 Feb. 2020. https://subscriber.politicopro.com/article/2020/02/fda-redefines-biological-product-in-final-rule-3976820
[3] Karlin-Smith, Sarah. “FDA commissioner hires 2 new advisers.” Politico Pro. 19 Feb. 2020. https://subscriber.politicopro.com/article/2020/02/fda-commissioner-hires-2-new-advisers-3976795
HOUSE.GOV
The Week Ahead
For the main events of the next week and more, go straight to the key events on the house.gov website.
SENATE.GOV
The Week Ahead
For the main events of the next week and more, go straight to the key events on the senate.gov website.