Nicholas Manetto

Nicholas Manetto

Faegre Drinker Biddle & Reath LLP

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Bipartisan Reform of 340B Drug Discount Program?

On February 2, 2024, a bipartisan group of six U.S. senators released much-anticipated draft legislation to reform the Health Resources and Services Administration’s (HRSA) 340B drug discount program. Known as the SUSTAIN...more

2/6/2024  /  Department of Health and Human Services (HHS) , Drug Pricing , HRSA , Pharmaceutical Industry , Pharmacy Benefit Manager (PBM) , Prescription Drugs , Section 340B

An Updated Look at the Federal Health Care Policy Legislative Landscape: Opportunity for Action or ‘Groundhog Day’?

With Congress again delaying full resolution of fiscal year 2024 (FY24) federal spending legislation, now until at least early March, health care stakeholders are once again left waiting to resolve several priority issues. ...more

1/25/2024  /  Medicare , Pharmaceutical Industry , Pharmacy Benefit Manager (PBM) , Prescription Drugs

Federal Health Care Legislative Agenda: Fall Updates

As Congress returns and summer turns to fall, the federal health care legislative agenda remains crowded. While much near-term energy is focused on September 30 and averting a shutdown of the federal government before the...more

9/8/2023  /  Centers for Medicare & Medicaid Services (CMS) , Continuing Resolution , Pharmaceutical Industry , Pharmacy Benefit Manager (PBM)

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

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

Requiring a Price Tag in Drug Commercials: Furthering Consumer Transparency or Government Overreach?

The Trump Administration released a draft regulation published in the Federal Register on October 18, 2018, which proposes to require drug manufacturers to include a drug’s list price in its direct-to-consumer (DTC)...more

10/19/2018  /  Advertising , Centers for Medicare & Medicaid Services (CMS) , Comment Period , Department of Health and Human Services (HHS) , Direct to Consumer Sales , Pharmaceutical Industry , Prescription Drugs , Television Commercials , Trump Administration

American Patients First: The Trump Administration's Blueprint to Lower Drug Prices

On Friday, May 11, 2018, President Trump delivered a highly anticipated speech addressing high drug prices and unveiling his administration’s blueprint to lower drug prices and reduce out-of-pocket costs. American Patients...more

5/15/2018  /  Department of Health and Human Services (HHS) , Drug Pricing , Medicare Part D , Pharmaceutical Industry , Prescription Drugs , Section 340B , Trump Administration

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

Dems Call for Hearing on Costs of Hep C Drug Sovaldi

Dialing up the issue of high-cost medications, Rep. Henry Waxman, the lead Democrat on the House Energy & Commerce Committee and Rep. Diana DeGette of Colorado are calling today for a hearing into the impact Sovaldi will have...more

6/20/2014  /  Food and Drug Administration (FDA) , Medicare , Pharmaceutical Industry , Prescription Drugs
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