It has been a busy year for issues related to drug pricing, and with the election around the corner, litigation issues that have been developing over the last few years are likely to be a key focus for the second half of...more
8/7/2024
/ Delisting ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Inflation Reduction Act (IRA) ,
Manufacturers ,
Orange Book ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Pharmacy Benefit Manager (PBM) ,
Popular ,
Prescription Drugs ,
Robinson-Patman Act
While only slightly past the midway point of 2023, it has already been a busy year for developments in drug pricing. Notably, CMS released its final guidance in preparation for price negotiations and the first 10 drugs...more
8/30/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Contract Negotiations ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Excise Tax ,
FTC Act ,
Inflation Reduction Act (IRA) ,
Manufacturers ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Preliminary Injunctions ,
Prescription Drugs ,
Section 340B ,
Transparency
Despite a busy 2022, drug pricing remains a hot topic at the federal and state levels, with a number of recent developments and trends worth monitoring heading into 2023. In the past year, the FTC increasingly focused on the...more
1/10/2023
/ Biden Administration ,
Drug Pricing ,
Enforcement ,
Federal Trade Commission (FTC) ,
FTC Act ,
Inflation Reduction Act (IRA) ,
Investigations ,
Legislative Agendas ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Rebates ,
Regulatory Agenda
States remain at the forefront of legislative efforts on a range of issues relating to drug pricing, such as increasing price transparency, capping out-of-pocket costs for insulin, and limiting certain PBM practices. These...more
9/15/2022
/ Disclosure Requirements ,
Drug Pricing ,
Health Care Providers ,
Manufacturers ,
Medicare Part B ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Price Transparency ,
Regulatory Agenda ,
Section 340B ,
State and Local Government ,
State Legislatures
The recent dismissal of an antitrust case against Sony relating to the sale of digital video games on the company's PlayStation Store could shed light on the viability of refusal-to-deal claims against platform technology...more
Federal efforts on drug pricing are increasingly focusing on the role of pharmacy benefit manager middlemen. A recently proposed Senate bill seeks to eliminate certain PBM practices, such as spread pricing and unfair claw...more
Among the drug pricing developments to watch in 2022, those at the top include legislation that would allow Medicare price negotiation and alter antitrust rules for the pharmaceutical industry, Federal Trade Commission...more
1/31/2022
/ Drug Pricing ,
Federal Trade Commission (FTC) ,
Legislative Agendas ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Price Transparency ,
Proposed Legislation ,
Rebates ,
Section 340B
State legislatures continue to push forward on drug pricing with legislation designed to reduce the cost of prescription drugs. Recent steps across a number of states include laying the groundwork for effective...more
On July 27, Reps. John Joyce (R-PA) and Jim Banks (R-IN) introduced legislation that would establish new US trade negotiating objectives for the pharmaceutical sector, in the context of a broader renewal of the trade...more
8/23/2021
/ Biden Administration ,
Enforcement ,
Export Controls ,
Pharmaceutical Industry ,
Proposed Legislation ,
Supply Chain ,
Tariffs ,
TPA Agreement ,
Trade Agreements ,
Trade Promotion Authority ,
United States-Mexico-Canada Agreement (USMCA) ,
US Trade Policies ,
WTO
Calls for changes to antitrust law, and how antitrust laws should be applied to the conduct of large technology companies, have been heating up in recent years. Now, the push for wide-scale changes to antitrust law has...more
8/2/2021
/ Biden Administration ,
Bipartisan Agreement ,
Competition ,
Department of Justice (DOJ) ,
Executive Branch ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Filing Fees ,
Legislative Agendas ,
Modernization ,
Proposed Legislation ,
Technology Sector
On Friday, July 9, 2021, President Biden signed Executive Order 14036, Promoting Competition in the American Economy, which includes—among 72 initiatives aimed at enhancing competition in the US—a directive encouraging the...more
Citing concerns about growing consolidation, reduced competition, and increasing prices, President Biden issued on July 9, 2021 a sweeping Executive Order containing 72 initiatives to address competition concerns in a number...more
The new Executive Order includes 72 initiatives instructing more than a dozen federal agencies to consider adopting rules intended to enhance competition.
A new Executive Order signed by President Biden includes 72...more
New challenges may lie ahead for the pharmaceutical industry -
What’s next for drug pricing in the US?
Proposals to alter antitrust and patent laws may signal a renewed focus on drug pricing by federal lawmakers,...more
On April 23, 2021, President Biden signed into law two bipartisan bills aimed at reducing prescription drug prices by supporting generic and biosimilar alternatives to branded drugs.
The Ensuring Innovation Act supports...more
On December 10, 2020, the Supreme Court in Rutledge v. Pharmaceutical Care Management Association held that ERISA does not pre-empt an Arkansas law regulating PBM prescription drug payment rates to pharmacies because it...more
12/23/2020
/ Drug Pricing ,
Employee Retirement Income Security Act (ERISA) ,
Health Insurance ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Preemption ,
Prescription Drug Coverage ,
Prescription Drugs ,
Rutledge v Pharmaceutical Care Management Association ,
SCOTUS
The Trump Administration recently announced two final rules that implement policy objectives to lower drug prices by tying certain Medicare Part B payments to prices paid by other countries and by replacing an anti-kickback...more
12/4/2020
/ Anti-Kickback Statute ,
Biden Administration ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
False Claims Act (FCA) ,
Final Rules ,
Medicare Part D ,
Most-Favored Nations ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Safe Harbors ,
Trump Administration
On September 13, 2020, President Trump issued an Executive Order seeking to establish most favored nation ("MFN") pricing for Medicare drug payments. The Trump Administration's Order, 'Lowering Drug Prices by Putting America...more
9/16/2020
/ Anti-Kickback Statute ,
Drug Pricing ,
Executive Orders ,
Imports ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Most-Favored Nations ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Rebates ,
Secretary of HHS ,
Trump Administration
On July 24 2020, President Trump signed three Executive Orders targeting prescription drug prices and proposed a fourth. The Orders represent the Trump Administration's latest effort to implement previously outlined...more
8/1/2020
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
FQHC ,
Healthcare Costs ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare ,
Pharmaceutical Industry ,
Popular ,
Prescription Drug Coverage ,
Prescription Drugs ,
Section 340B ,
Trump Administration
With proposed federal legislation on pause, state legislatures continue to target the pricing of pharmaceuticals, passing a number of new laws in 2020. As complexity at the state level continues to increase, pharmaceutical...more
While drug pricing continues to be an important political issue in the United States, it has been state legislatures, not the federal government, that have been able to translate policy proposals into new laws.
Over the...more