Vince Sampson on Food and Drug Administration (FDA)

FDA Greenlights Florida’s Proposal for Importing Prescription Drugs From Canada

On Friday, January 5, 2024, the US Food and Drug Administration (FDA) authorized the Section 804 Importation Program (SIP) proposal of Florida’s Agency for Health Care Administration (FAHCA). The SIP is a pathway that allows...more

1/15/2024 / Canada , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Imports , Pharmaceutical Industry , Prescription Drugs

DOJ Previews Enforcement Policies Aimed at Clinical Trial Fraud

On December 9, 2021, one of the nation’s top healthcare prosecutors made clear that clinical trial fraud will be a major enforcement priority of President Joe Biden’s Department of Justice. Speaking at the Food and Drug Law...more

12/21/2021 / Clinical Trials , Criminal Penalties , Department of Justice (DOJ) , Food and Drug Administration (FDA) , Fraud

Blog: Drug Pricing 2019 Year in Review

In 2019, Congress and the Administration set out to make strides to effectuate policies to curb the rising costs of prescription drugs. These efforts while significant in number, were few in completion. Congress, while...more

1/2/2020 / Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , Medicare , Medicare Part B , Medicare Part D , Pharmaceutical Industry , Prescription Drugs , Trump Administration

Blog: Administration releases drug importation plan but implementation questions abound

Yesterday, the Department of Health and Human Services (HHS) announced two “pathways” for drug importation. This plan is the latest step in the Administration’s push to lower prescription drug prices and one the President has...more

8/1/2019 / Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , Imports , Pharmaceutical Industry , Prescription Drugs

Blog: President set to outline drug pricing plan: how far will it go?

Tomorrow at 2 p.m., EST, the President is scheduled to deliver a long-awaited drug pricing strategy speech to put “America’s patients first.” While details of the speech have been closely held, it is anticipated that it...more

5/10/2018 / Drug Pricing , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs , REMS , Trump Administration

Blog: Drug Costs Targeted in Administration’s Fiscal Year 2019 Budget

Yesterday, the Administration released its Fiscal Year 2019 (FY19) Budget blueprint. The $4.4 trillion Budget blueprint includes several proposals directed at lowering the cost of prescription drugs. These proposals are...more

2/13/2018 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Federal Budget , Food and Drug Administration (FDA) , Generic Drugs , Medicare Part D , Prescription Drugs

Blog: FDA Releases Digital Health Guidance to Spur Innovation

On December 7th, the Food and Drug Administration (FDA) announced the release of a much-anticipated suite of guidance documents that loosen the regulatory requirements for digital health technologies. By clarifying what is –...more

12/19/2017 / 21st Century Cures Act , Digital Health , Draft Guidance , Food and Drug Administration (FDA) , Medical Devices

Blog: Off-Label Use Gets Congressional Hearing

Today, the House Energy and Commerce Committee will hold a hearing tilted “Examining Medical Product Manufacturer Communications.” According to the Committee, the focus of the hearing will be how the Food and Drug...more

7/12/2017 / Food and Drug Administration (FDA) , Labeling , Manufacturers , Medical Devices , Off-Label Use , Product Labels

Blog: User Fee Reauthorization Picks Up Steam

In preparation for a vote this week, the House of Representatives Committee on Energy and Commerce yesterday released a new draft of the user fee reauthorization. The bill, titled the “FDA Reauthorization Act of 2017,”...more

7/11/2017 / FDA Reauthorization Act , Food and Drug Administration (FDA) , Prescription Drugs , User Fees

Blog: User Fee Act Legislation Introduced Free of Controversial Issues…for the Time Being

Recently, the House Energy and Commerce Committee and Senate Health, Education, Labor and Pensions (HELP) Committee introduced a bipartisan discussion draft of legislation to reauthorize the Food and Drug Administration’s...more

4/27/2017 / Biosimilars , Food and Drug Administration (FDA) , HELP , Prescription Drugs

Blog: Price Confirmed For HHS Secretary, Other Key Agency And Department Positions Next To Be Filled

Around 2 a.m., the Senate voted along party lines to confirm Representative Tom Price to become Secretary of the Department of Health and Human Services. The vote was 52-47 with no Democrats voting in favor. With repeated...more

2/13/2017 / Affordable Care Act , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA)

Blog: 21st Century Cures Clears Senate, President Expected to Sign into Law but Some Issues Remain

Today, the Senate voted overwhelmingly – 94-5 – to pass sweeping medical innovation legislation clearing the way for President Obama to sign it into law when it reaches his desk later this week. The 21st Century Cures Act,...more

12/8/2016 / 21st Century Cures Initiative , Food and Drug Administration (FDA) , Health Care Providers , Medical Devices , Prescription Drugs

Alert: FDA Issues Draft Cybersecurity Guidance to Medical Device Manufacturers

On January 22, 2016, the US Food and Drug Administration ("FDA") issued draft guidance outlining important steps medical device manufacturers should take to address cybersecurity risks in order to improve patient safety and...more

2/23/2016 / Cybersecurity , Draft Guidance , Food and Drug Administration (FDA) , Information Sharing , Manufacturers , Medical Devices , Risk Management

Blog: Senator Calls on Med Device Leaders to Improve Cybersecurity

Late last week, Senator Barbara Boxer (D-CA) wrote to the leaders of Johnson & Johnson, GE Healthcare, Siemens USA, Medtronic and Philips USA, to “express serious concerns” about potential cybersecurity vulnerabilities in...more

2/10/2016 / Cybersecurity , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , General Electric , Johnson & Johnson , Medical Devices , Medtronic , Philips Electronics , Siemens

Blog: Senate Opts For “Step By Step” Approach For Innovation Legislation

Tuesday, Senator Lamar Alexander (R-Tenn.), Chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee announced that he will pursue a “step by step” approach to crafting major biomedical innovation...more

1/23/2016 / Food and Drug Administration (FDA) , HELP , Innovation , Legislative Agendas , Medical Devices , Proposed Legislation

Blog: Trend Watch: First Amendment Challenges To FDA Promotional Requirements Continue

In the wake of Amarin Pharma’s victory in securing a preliminary injunction against the Food and Drug Administration’s (FDA) prohibition of off-label communication of Vacepa , Pacira Pharmaceuticals has filed a First...more

9/21/2015 / Advertising , Amarin , First Amendment , Food and Drug Administration (FDA) , Off-Label Promotion , Pharmaceutical Industry , Preliminary Injunctions

Alert: Federal Policy Developments Impacting Medical Technology Companies

Health care is always a major issue in Washington, DC but recently how to promote innovation in medtech has become a priority within that conversation. Thus far, 2015 has produced a major legislative initiative in the form of...more

3/19/2015 / Digital Health , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Healthcare , Internet of Things , Technology

Alert: FDA Finalizes Guidance on Devices that Store and Transfer Data

The Food and Drug Administration (FDA) on February 6th, finalized guidance on certain medical devices that store and transfer data, opting for a very light regulatory touch. In its guidance, the FDA states that it doesn't...more

2/16/2015 / Data Collection , Digital Health , Food and Drug Administration (FDA) , Medical Device Data System , Medical Devices , mHealth , Software

Blog: FDA Releases List of FY 2015 of Guidance Priorities

On January 9th, the Food and Drug Administration (FDA) released lists of final and draft guidance documents they intend to publish in Fiscal Year 2015. This guidance is a first for the FDA and comes as a product of...more

1/12/2015 / Draft Guidance , Final Guidance , Food and Drug Administration (FDA) , Medical Devices

Vince Sampson

Cooley LLP

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