Health Care

Database for Dietary Ingredient Content of Dietary Supplements

Scientists from the Agricultural Research Service’s (ARS) Nutrient Data Laboratory, part of the Beltsville Human Nutrition Research Center, and the National Institutes of Health’s (NIH) Office of Dietary Supplements, in collaboration with other federal agencies, earlier this year updated and released a database that validates the content of popular dietary supplements — the Dietary Supplement […]

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The Public Isn’t Buying What the CPSC Is Selling

Health Care / Joi Jackson

By former CPSC Commissioner Nancy Nord The U.S. Consumer Product Safety Commission (CPSC) may want to help people sleep better at night, but their actions are more likely to keep people up or give them nightmares. This past week the CPSC re-announced a recall of portable, adult bed handles because the original announcement garnered such a low response

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EPA Hazardous Waste Pharmaceuticals Rule Begins Circulating: Proposal Applies To Dietary Supplements, 503B Outsourcing Facilities, And Any OTC Retailers

EPA, FDA, Health Care / Joi Jackson

On Tuesday, the Environmental Protection Agency (EPA) announced that its Administrator signed the proposed rule: Management Standards for Hazardous Waste Pharmaceuticals Rule. The announcement and EPA blog post are here. The summary of the pre-publication proposed rule is available here and the 267-page proposal is available for download here. EPA is expected to publish the

EPA Hazardous Waste Pharmaceuticals Rule Begins Circulating: Proposal Applies To Dietary Supplements, 503B Outsourcing Facilities, And Any OTC Retailers Read More »

Privacy Update: Refill Reminders Expressly Permitted In California – The State Finally Catches Up to the Feds

Health Care / Joi Jackson

Although HIPAA-compliant sponsored “refill reminders” have always been legally permissible for a host of treatments under California’s Confidentiality of Medical Information Act (CMIA), Cal. Civ. Code §§ 56-56.37, the state finally came right out and said so. California’s Office of Health Information Integrity (CalOHII), just published its long-awaited State Health Information Policy Manual (“Manual” or

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Device Firms: What You Should Know About The 21st Century Cures Act

FDA, Health Care, Public Policy / Joi Jackson

Last month, legislation that would affect, among other things, FDA’s regulation of medical devices and the manufacturers of such devices took a considerable step forward when it was introduced and then unanimously approved by the House Energy and Commerce Committee by a vote of 51-0 on May 21. Known as the 21st Century Cures Act (“Act”),

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May 19 Webinar on the Drug Supply Chain Security Act

Health Care, OFW Law News, Public Policy / Joi Jackson

Tish Eggleston Pahl will be speaking on May 19 at a webinar on dispenser obligations under the Drug Supply Chain Security Act (DSCSA). The webinar is sponsored by the Healthcare Distribution Management Association (HDMA). This “DSCSA Overview for Dispensers” continues HDMA’s education and outreach on the pharmacy and hospital–related implementation requirements under the DSCSA. Particular focus

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Hand Washing: A Simple Step

Health Care, USDA / Joi Jackson

By Barbara J. Masters, D.V.M. How many of you have ever sat in a public location, such as the airport, and watched the number of people that enter the restroom talking on their cell phone? Creepy, huh? Not nearly as creepy as the same number of people that exit a very short time later still talking

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Warning Letters Update

FDA, Health Care / Chris Kirksey

This past week FDA made a number of Warning Letters available on its website, with issues ranging from Juice HACCP to cGMPs for finished pharmaceuticals. A Warning Letter is informal and advisory, with the aim to achieve voluntary compliance and to establish prior notice. It communicates the agency’s position on a matter, but it does

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2015 Dietary Guidelines Advisory Committee Report Mixes Science and Policy

FDA, Health Care, Public Policy, USDA / Chris Kirksey

The 2015 Dietary Guidelines Advisory Committee (DGAC) submitted its report to the Secretaries of Agriculture and Health and Human Services last month and disbanded. It is now up to the USDA and HHS to take the DGAC’s conclusions and recommendations and issue a revised edition of the Dietary Guidelines for Americans. Interested persons may submit

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Webinar: Drug Supply Chain Security Act Overview for Dispensers

FDA, Health Care, Public Policy / Chris Kirksey

On April 21, OFW Law’s Tish Eggleston Pahl will participate in a webinar being held by the Healthcare Distribution Management Association (HDMA) for dispensers on implementation of the Drug Supply Chain Security Act (DSCSA) Register Today! Learn what is expected of dispensers as it relates to the DSCSA through a HDMA webinar on Tuesday, April 21 from 2:00–3:00

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Dietary Guidelines – Confused About Caffeine

Health Care, Public Policy, USDA / Chris Kirksey

The news wires have been buzzing lately about the recently released scientific report of the Dietary Guidelines Advisory Committee. One of the hottest topics for discussion is how out of step the report is on a number of issues, including the Committee’s dive into political matters like sustainability, soda taxes, and “added sugar” labeling. These

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Who Regulates the Advertising of Your App?

FDA, Health Care / Chris Kirksey

We have blogged and hosted numerous webinars on FDA regulation of mobile medical apps (see here, here, here, here and here); but if you are an app developer, you should be aware that FDA is not the only agency looking at your app. The Federal Trade Commission (FTC) may also be watching how you promote your app. In fact, on February 23, 2015 the

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Privacy Update: White House Drops Draft Consumer Privacy Bill . . . Splat!

Health Care, Public Policy / Chris Kirksey

The White House (via the Department of Commerce) has released a “discussion draft” of consumer privacy legislation intended to codify President Obama’s 2012 Consumer Data Privacy In A Networked World: A Framework For Protecting Privacy And Promoting Innovation In The Global Digital Economy. The 2012 Framework included a Consumer Privacy Bill of Rights and called

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Drug Supply Chain Security Act – What’s Next? A whole lot.

FDA, Health Care, Public Policy / Chris Kirksey

The passage of the Drug Supply Chain Security Act (DSCSA) in November 2013 led to a very busy 2014 as FDA and manufacturers, wholesale distributors, and dispensers began the statute’s complex 10-year implementation. 2015 promises to be equally busy. A Surge Of Activity At Year-End In 2014 2014 closed in a flurry of DSCSA action.

Drug Supply Chain Security Act – What’s Next? A whole lot. Read More »

Statement by Senator Bob Dole on Nutrition Report

Health Care, Public Policy, USDA / Chris Kirksey

Contact: Marshall Matz (202) 789-1212; mmatz@ofwlaw.com or Marion Watkins (202) 654-4863; marion.watkins@alston.com “As co-author with Senator George McGovern of the original 1977 ‘Dietary Goals for the United States’ report, I commend the USDA, HHS and its Dietary Guidelines Advisory Committee for continuing to focus attention on human nutrition. The Committee’s recently-released report notes the staggering numbers of

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FDA’s Draft Guidance On DSCSA Preemption Misses The Mark

FDA, Health Care, Public Policy / Chris Kirksey

In a flurry of end-of-year activity, FDA recently issued a Draft Guidance on the express preemption provisions in §585 of the FDC Act, added last year by the Drug Supply Chain Security Act (or DSCSA). FDA, the pharmaceutical supply chain, and other stakeholders have been working very hard to implement the DSCSA as quickly as

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FTC Reminds Us That HHS’s Office for Civil Rights Not Only One Watching Medical Privacy

Health Care / Chris Kirksey

Seasons greetings from the Federal Trade Commission (FTC). Yesterday, the FTC published its Agreement Containing Consent Order and attendant press release regarding its settlement with a medical billing company (PaymentsMD) and the company CEO for alleged failure to adequately inform patients regarding the company’s collection of their medical records. Although not arising under HIPAA (which

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Webinar Tomorrow: What Dispensers Need to Know About the Drug Supply Chain Security Act

FDA, Health Care, Public Policy / Chris Kirksey

A Complimentary Webinar Presented by OFW Law’s Tish Pahl and the Food Marketing Institute Thursday, December 4th, 2014 3:00 pm – 4:00 pm US/Eastern Please join FMI on a webinar with Tish Pahl —Under the Drug Supply Chain Security Act (DSCSA), beginning January 1, 2015, manufacturers, wholesaler drug distributors, and repackagers, must provide transaction data

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The DSCSA Standards Guidance is here!

1 Comment / FDA, Health Care, Public Policy / Chris Kirksey

This morning, FDA met another of its milestones in implementing the Drug Supply Chain Security Act (DSCSA) and posted a Draft Guidance, DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information. FDA is to be commended for both getting the Draft Guidance

The DSCSA Standards Guidance is here! Read More »

Consumer-Directed Promotions About Prescription Drugs: A Look Back at Print and TV Communications

FDA, Health Care, OFW Law News, Public Policy / Chris Kirksey

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part VI) By Tish Eggleston Pahl In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to share some highlights throughout the years. Parts I, II, III, IV and V focus on

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GMPs Have Long History That Precedes Application In Medical Products

1 Comment / FDA, Health Care, OFW Law News, Public Policy / Chris Kirksey

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part V) By Neil P. Di Spirito In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to share some highlights throughout the years. Parts I, II, III, and IV focused on

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26 Years, With 9 To Go…. 35 Years to Prescription Drug Traceability

2 Comments / FDA, Health Care, OFW Law News, Public Policy / Chris Kirksey

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part IV) By Tish Eggleston Pahl In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to share some highlights throughout the years. Parts I, II, and III focused on Hatch-Waxman, medical

26 Years, With 9 To Go…. 35 Years to Prescription Drug Traceability Read More »

The Realized Benefits of User Fees

3 Comments / FDA, Health Care, OFW Law News, Public Policy / Chris Kirksey

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part III) In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to share some highlights throughout the years. Parts I and II focused on Hatch-Waxman and medical privacy laws, while

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Phil Olsson and Rick Frank on 35 Years of Life at OFW

FDA, Health Care, OFW Law News, Public Policy, USDA / Chris Kirksey

Phil: Rick, it’s hard to believe that 35 years have passed since we started this firm as a two-lawyer shop in 1979. Rick: It sure is. I remember working with you at the law firm I joined fresh out of the University of Michigan Law School, and which you had joined several years earlier out

Phil Olsson and Rick Frank on 35 Years of Life at OFW Read More »

HIPAA Comes of Age… Thanks to HITECH, D.D.S.

4 Comments / FDA, Health Care, OFW Law News, Public Policy / Chris Kirksey

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part II) In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to share some highlights from throughout the years. Part I focused on Hatch-Waxman. Today’s blog focuses on the development

HIPAA Comes of Age… Thanks to HITECH, D.D.S. Read More »

Thirty Years of Hatch Waxman

4 Comments / FDA, Health Care, OFW Law News, Public Policy / Chris Kirksey

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part I) Since its inception in 1979, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practices have focused on myriad regulatory issues arising under FDA and broader HHS jurisdiction. We advise clients on matters ranging from Hatch-Waxman and generic drug marketing exclusivity

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The Next Dietary Guidelines Debate

Health Care, Public Policy, USDA / Chris Kirksey

By Marshall L. Matz and Nathaniel B. Fretz, as published by Agri-Pulse There is a new question surrounding the Dietary Guidelines for Americans now being drafted for release in 2015. The question is whether the Dietary Guidelines Advisory Committee should continue to focus their review and recommendations on scientific advances in nutrition and diet or should they venture

The Next Dietary Guidelines Debate Read More »

Following the Money: House And Senate Appropriations Release Draft Bills & Reports Funding FDA For FY 2015

FDA, Health Care, Public Policy / Chris Kirksey

The House and Senate Appropriations Committees with oversight of FDA have been very busy. Both voted out draft bills for FY 2015 that include appropriations for FDA and released draft reports. Roger Szemraj and the rest of our government relations practice have scoured the draft bills and reports looking for insight into what FDA drug-related activities

Following the Money: House And Senate Appropriations Release Draft Bills & Reports Funding FDA For FY 2015 Read More »

HHS Releases HIPAA Security Rule Risk Assessment Tool

FDA, Health Care / Reed Diskey

The Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR), Office of the National Coordinator for Health Information Technology (ONC), and Office of the General Counsel (OGC), have released their Security Risk Assessment (SRA) tool. The SRA tool is designed to assist Covered Entities and their Business Associates (BA) ensure compliance with

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CPSC Proposes to Make Voluntary Recalls and Compliance Programs Legally Binding

Health Care, Public Policy / Chris Kirksey

On November 13, 2013, the U.S. Consumer Product Safety Commission (CPSC) issued a proposed interpretive rule concerning corrective action plans for “voluntary” recalls that may impact future voluntary consumer product recalls in two significant ways. First, CPSC proposes to make voluntary recall agreements that companies negotiate with CPSC legally binding. Second, CPSC proposes to permit

CPSC Proposes to Make Voluntary Recalls and Compliance Programs Legally Binding Read More »

OFW Law’s MMXIII in Retrospect

FDA, Health Care, OFW Law News, Public Policy, USDA / Chris Kirksey

As MMXIV starts, it’s time for a retrospective look at MMXIII. What follows is a list of noteworthy events from MMXIII in our food, drug, medical device, and agriculture corner of the universe, focusing on matters that were of particular interest to OFW Law’s attorneys and Senior Policy Advisors and our clients. We start, of

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And They’re Off! FDA Wastes No Time in Implementing its New Compounding Authority

FDA, Health Care, Public Policy / Chris Kirksey

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And They’re Off! FDA Wastes No Time in Implementing its New Compounding Authority Read More »

Regulatory Mismanagement of Medical Foods?

FDA, Health Care / Chris Kirksey

FDA published in yesterday’s Federal Register notice of a 30 day (albeit 60 days had been requested) reopening of the comment period on its Draft Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition, updated in August 2013. Prior versions of the guidance document had been published in May 1997 and May 2007.

Regulatory Mismanagement of Medical Foods? Read More »

Bienvenue Aux Etats-Unis!

FDA, Health Care, Public Policy / Chris Kirksey

With so many of our respected friends and colleagues furloughed, federal agency budgets decimated, or wholly dependent on user fees to operate, and so much important business on hold due to the intransigent federal budget showdown, it’s not surprising that the States have stepped up to fill the vacuum. One example is the State of

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HHS Guidance Expands Scope of Refill Reminders and Reasonable Costs

Health Care / Chris Kirksey

As we reported recently, the Department of Health and Human Services (HHS) announced its intent to issue guidance regarding prescription “refill reminder” programs that can be conducted without patient authorization by September 23, 2013. HHS’s Office for Civil Rights (OCR) actually beat that deadline by four days, publishing its Guidance on September 19, 2013. OCR’s

HHS Guidance Expands Scope of Refill Reminders and Reasonable Costs Read More »

Database for Dietary Ingredient Content of Dietary Supplements

The Public Isn’t Buying What the CPSC Is Selling

EPA Hazardous Waste Pharmaceuticals Rule Begins Circulating: Proposal Applies To Dietary Supplements, 503B Outsourcing Facilities, And Any OTC Retailers

Privacy Update: Refill Reminders Expressly Permitted In California – The State Finally Catches Up to the Feds

Device Firms: What You Should Know About The 21st Century Cures Act

May 19 Webinar on the Drug Supply Chain Security Act

Hand Washing: A Simple Step

Warning Letters Update

2015 Dietary Guidelines Advisory Committee Report Mixes Science and Policy

Webinar: Drug Supply Chain Security Act Overview for Dispensers

Dietary Guidelines – Confused About Caffeine

Who Regulates the Advertising of Your App?

Privacy Update: White House Drops Draft Consumer Privacy Bill . . . Splat!

Drug Supply Chain Security Act – What’s Next? A whole lot.

Statement by Senator Bob Dole on Nutrition Report

FDA’s Draft Guidance On DSCSA Preemption Misses The Mark

FTC Reminds Us That HHS’s Office for Civil Rights Not Only One Watching Medical Privacy

Webinar Tomorrow: What Dispensers Need to Know About the Drug Supply Chain Security Act

The DSCSA Standards Guidance is here!

Consumer-Directed Promotions About Prescription Drugs: A Look Back at Print and TV Communications

GMPs Have Long History That Precedes Application In Medical Products

26 Years, With 9 To Go…. 35 Years to Prescription Drug Traceability

The Realized Benefits of User Fees

Phil Olsson and Rick Frank on 35 Years of Life at OFW

HIPAA Comes of Age… Thanks to HITECH, D.D.S.

Thirty Years of Hatch Waxman

The Next Dietary Guidelines Debate

Following the Money: House And Senate Appropriations Release Draft Bills & Reports Funding FDA For FY 2015

HHS Releases HIPAA Security Rule Risk Assessment Tool

CPSC Proposes to Make Voluntary Recalls and Compliance Programs Legally Binding

OFW Law’s MMXIII in Retrospect

And They’re Off! FDA Wastes No Time in Implementing its New Compounding Authority

Regulatory Mismanagement of Medical Foods?

Bienvenue Aux Etats-Unis!

HHS Guidance Expands Scope of Refill Reminders and Reasonable Costs

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