Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
8/18/2017
/ Cosmetics ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Pilot Programs ,
Food and Drug Administration (FDA) ,
GAO ,
Health Care Providers ,
Healthcare Fraud ,
Medical Devices ,
Opioid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
On July 18, 2017, the Government Accountability Office (GAO) issued a follow-up report entitled “Update on Agency Efforts to Improve 340B Program Oversight.” In its initial report in 2011, the GAO highlighted the inherent...more
A recent House bill, titled the "Closing Loopholes for Orphan Drugs Act," would narrow the exception for orphan drugs in the federal 340B Drug Pricing program. Representative Peter Welch (D-VT) introduced the bill on June 13,...more
On April 19, 2017 a coalition of hospitals and safety-net providers, known as the 340B Coalition, submitted correspondence urging the government to implement regulations that would subject pharmaceutical manufactures to civil...more
In what amounts to a victory for the pharmaceutical industry, on October 14, 2015, the U.S. District Court for the District of Columbia vacated the interpretive rule issued by the U.S. Department of Health and Human Services...more
10/27/2015
/ Administrative Authority ,
Administrative Procedure Act ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Discount Pricing ,
HRSA ,
Interpretive Rule ,
Orphan Drugs ,
Pharmaceutical Industry ,
PHRMA ,
Section 340B ,
Vacated
The United States Government Accountability Office (GAO) recently released a report entitled “Medicare Part B Drugs: Action Needed to Reduce Financial Incentives to Prescribe 340B Drugs at Participating Hospitals” (“the...more
7/14/2015
/ Beneficiaries ,
GAO ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Medicare ,
Medicare Part B ,
Physicians ,
Prescription Drug Coverage ,
Prescription Drugs ,
Section 340B