Lauren Bloch at Faegre Drinker Biddle & Reath LLP

Three New Prescription Drug Innovation Models Latest Action on Drug Pricing

As the Biden administration moves ahead to implement provisions of the Inflation Reduction Act (IRA), including those related to drug negotiation and inflationary rebate, the administration announced three Medicare and...more

2/17/2023 / Centers for Medicare & Medicaid Services (CMS) , CMMI , Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , Medicare Part B , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

What to Know Before Getting Back to the Business of Health Care: FY2023 Omnibus Spending Bill

In late December, Congress passed and President Biden signed into law a $1.7 trillion year-end omnibus spending bill to fund the federal government through FY2023. This alert summarizes the notable health policies and...more

1/6/2023 / HDHPs , Health Insurance , Health Savings Accounts , Medicaid , Medicare , Mental Health , Substance Abuse

Fall 2022 Federal Healthcare Legislative Landscape

With President Biden signing the Inflation Reduction Act (IRA) into law on August 16, the next big question is what the last third of 2022 will bring. Enacting the IRA takes the “will it or won’t it happen” issue of...more

8/26/2022 / Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Inflation Reduction Act (IRA) , Medicare , Telehealth , User Fees

Lawmakers Introduce Cures 2.0 Legislation

Nearly five months after releasing their initial 21st Century Cures 2.0 draft, Congressman Fred Upton (R-MI) and Congresswoman Diana DeGette (D-CO) introduced the long-anticipated bill on November 15. The bill includes...more

11/18/2021 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , PDUFA , Pharmaceutical Industry

Weighing Benefits and Risks: New Draft Guidance Offers Insights on FDA Decision-Making

In late September, the Food and Drug Administration (FDA) released a draft guidance on benefit-risk assessments for drugs and biological products. The draft guidance includes considerations the agency uses when weighing the...more

10/6/2021 / Biologics , Draft Guidance , Food and Drug Administration (FDA) , PDUFA , Prescription Drugs , User Fees

Substance Use Disorder Treatment Centers: Uncovering Fraud and Advancing Policies to Promote Best Practices

On June 9, 2021, Arnold Ventures, researchers from the Boston University School of Public Health and Faegre Drinker hosted a virtual event to explore the issue of fraud in substance use disorder (SUD) treatment. In response...more

6/15/2021 / Drug Treatment , Enforcement Actions , Fraud , Health Care Providers , Substance Abuse

Patient Perspectives—There’s an App for That!

On November 7, the U.S. Food and Drug Administration (FDA) announced the launch of the MyStudies app, the latest in a series of concrete activities to drive the integration of the patient voice in clinical trials and the drug...more

11/12/2018 / Food and Drug Administration (FDA) , Health Care Providers , Mobile Health Apps , Pharmaceutical Industry

In 2018 Strategic Policy Roadmap, FDA Unveils Plans for 2018 Addiction, Drug Competition and Innovation Efforts

On January 11, 2018, the Food and Drug Administration (FDA) released its 2018 Strategic Policy Roadmap, which sheds light on the agency’s key focus areas for the year. This Roadmap builds on some of the FDA’s existing work,...more

1/15/2018 / 21st Century Cures Act , Food and Drug Administration (FDA) , Opioid , Prescription Drugs , REMS

How Might the FDA's Proposed Patient Affairs Office Impact Patient Advocacy Efforts?

Earlier this month, the Food and Drug Administration (FDA) solicited public comments on the agency’s proposal to create a new Office of Patient Affairs. The agency said in its Federal Register notice that the concept was...more

3/29/2017 / Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

Lauren Bloch

Faegre Drinker Biddle & Reath LLP

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