In the first week of 2023, the Biden administration announced two actions centered on expanding access to medication abortion. The first involves a policy change by the FDA regarding the ability of retail pharmacies to...more
1/13/2023
/ Abortion ,
Biden Administration ,
Department of Justice (DOJ) ,
Food and Drug Administration (FDA) ,
New Legislation ,
Patient Access ,
Pharmaceutical Industry ,
Pharmacies ,
Policy Statement ,
Pregnancy ,
Reproductive Healthcare Issues ,
State and Local Government
On May 11, the U.S. Food and Drug Administration (FDA) released two guidance documents to provide recommendations for sponsors “to accelerate development” of drugs and biologics designed to prevent or treat COVID-19. ...more
On May 8, 2019, the Centers for Medicare & Medicaid Services (“CMS”) finalized the regulation (“Final Rule” or “DTC Rule”) requiring direct-to-consumer (“DTC”) prescription drug television advertisements to include the...more
5/14/2019
/ Acquisitions ,
Advertising ,
Centers for Medicare & Medicaid Services (CMS) ,
Direct to Consumer Sales ,
Drug Pricing ,
First Amendment ,
Lanham Act ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Wholesale
On October 15, 2018, the Centers for Medicare & Medicaid Services (CMS) published a Proposed Rule requiring disclosures by pharmaceutical manufacturers of the list price for certain drugs and biologicals directly or...more
The Food and Drug Administration (FDA) issued a new guidance document on Dear Health Care Provider (DHCP) letters, titled “Dear Health Care Provider Letters: Improving Communication of Important Safety Information.” DHCP...more