In a break with past precedent, last year’s Food and Drug Administration (FDA) user fee reauthorization legislation did not contain significant FDA policy changes. Although the Senate Health, Education, Labor and Pensions...more
Key Points -
The new drug price negotiation process under the IRA takes into account a complex mix of price, competitive status, market exclusivity and scientific data.
New price setting provisions built into the IRA...more
With the second session of the 117th Congress underway, stakeholders are poised for another busy legislative session set against the dynamic backdrop of an ongoing global pandemic and midterm election year. Numerous...more
As has been widely reported, earlier this summer, President Biden issued Executive Order (EO) 14036, “Promoting Competition in the American Economy.” The EO provides insight into how the Biden-Harris administration plans to...more
9/10/2021
/ Biden Administration ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Competition ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Healthcare Reform ,
Hospitals ,
Life Sciences ,
Pharmaceutical Industry
• The administration’s drug pricing Blueprint combines proposals that are already under way with new initiatives that may or may not be adopted.
• Many of the more dramatic proposals would require federal rulemaking or...more
5/17/2018
/ Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Health Care Providers ,
Legislative Agendas ,
Medicaid ,
Medicare ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Patients ,
Pharmaceutical Industry ,
Prescription Drugs ,
Request For Information ,
Section 340B ,
Trade Agreements ,
Trump Administration ,
WTO