On Monday, May 12, President Donald Trump signed an Executive Order (EO) titled, “Delivering Most-Favored-Nation Prescription Drug Pricing to Americans,” aimed at reducing prescription drug prices by implementing a...more
Key Points - GLP-1 agonists have ushered in a new era in anti-obesity medication policy considerations against the backdrop of a continued focus by policymakers on both drug access and pricing. CMS has taken steps to clarify...more
5/29/2024
/ Abbreviated New Drug Application (ANDA) ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
Medicare ,
Medicare Modernization Act ,
Medicare Part D ,
National Institute of Health (NIH) ,
Orange Book ,
Patents ,
Pharmaceutical Industry
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
4/25/2024
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Review Act ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
GAO ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
HRSA ,
Laboratory Developed Tests ,
Medicaid ,
Medicare ,
NIST ,
Nursing Homes ,
OIG ,
OIRA ,
OMB ,
Payment Systems ,
PHI ,
Policies and Procedures ,
Prescription Drugs ,
Presidential Elections ,
Proposed Guidance ,
Regulatory Agenda ,
Regulatory Standards ,
Rulemaking Process
Congress is taking a closer look at business practices in the health care sector and considering bipartisan reforms in light of increasing consolidation and its perceived affects on patient access and affordability. Various...more