Tag Archives: Food and Drug Administration

FDA Delays “Intended Use” Final Rule until March 2018

Late last week, the U.S. Food and Drug Administration (FDA) announced that it was once again delaying implementation of the final rule issued January 9, 2017 related to amendments to its regulations regarding intended use (Final Rule). This implementation delay follows a Petition to Stay and for Reconsideration (Petition) filed February 8, 2017 by the Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Biotechnology Innovation Organization (BIO). The Petition argued that the Final Rule’s inclusion of a “totality of the evidence” standard is a new standard not found in the Food, Drug, and Cosmetic Act (FDCA) or case law related to intended use and was promulgated in violation in the APA because parties subject to this significant liability standard did not receive fair notice or a meaningful opportunity to comment.

Continue reading

Leave a comment

Filed under FDA, FDA Final Guidance

FDA Announces Critical Off-Label Forum for Drugs and Devices

A notice was published today in the Federal Register regarding a two day public hearing that will be held on November 9-10, 2016 by the U.S. Food and Drug Administration (FDA) to obtain input from a wide range of stakeholders regarding communications by industry related to unapproved uses of FDA-regulated drugs, biological products and medical devices (collectively, “Medical Products”). The announcement noted that FDA has been engaged in a comprehensive review of its regulations and policies related to off-label communications of approved or cleared Medical Products since 2014, and input from the meeting will further inform FDA’s policy development.

Continue reading

1 Comment

Filed under FDA

All is Well:  FDA to Host Webinar on its Final Guidance for Low-Risk General Wellness Devices on September 1, 2016

The U.S. Food and Drug Administration (FDA) recently released final version of its guidance, General Wellness:  Policy for Low-Risk Devices (Policy), with a webinar slated for September 1st as part of the rollout.  While not much has changed from the 2015 draft guidance, the number of mobile apps and general wellness products that are pushing the limits of what the FDA believes could be “devices” under the Food, Drug, and Cosmetic Act (FDCA) increases daily.

In order to fit under the FDA Policy, the product needs to both solely marketed for general wellness and present a low risk of safety to the user and other persons. The guidance provides useful examples that anticipate the desire to help  “reduce the risk of” or “live well with” chronic conditions, the most interesting boundaries of the Policy for those wishing to differentiate themselves within the wellness industry.

Agency metrics on the 513(g) Requests for Information may provide some feedback on the impact of the Policy since its draft issuance, and future enforcement needs to be monitored for defining the limits of the Policy.

Leave a comment

Filed under FDA Final Guidance, Health IT, Medical Devices

FTC Announces Guidance for Developers of Mobile Health Apps

Chairwoman Edith Ramirez of the Federal Trade Commission (FTC) announced the release of new guidance directed towards developers of mobile health apps (the “Guidance”), while speaking today at the International Association of Privacy Professionals (IAPP) conference in Washington, DC.  The Guidance is a tool created in collaboration with the FTC, the U.S. Department of Health and Human Services (HHS), and the Food and Drug Administration (FDA) to assist app developers in determining what laws and regulations apply to their products. Continue reading

Leave a comment

Filed under FDA, Health Care, Health Information Privacy, Health IT, HIPAA, Medical Devices, Mobile Health, Privacy and Security

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 their medical devices.  From the letter, the rationale for selecting these companies is that together they “control more than one-quarter of the global medical device market” and it is her hope that they can send “a signal” to the broader medical device industry. Continue reading

Leave a comment

Filed under FDA Draft Guidance, Health IT, Medical Devices, Technology, Uncategorized

“Common Rule” Overhaul Proposed – Intended to Modernize Human Research Subject Protections

On September 2, 2015, sixteen federal agencies and departments jointly issued a Notice of Proposed Rulemaking (“the NPRM”), designed to “modernize, strengthen, and make more effective” the so-called “Common Rule”.  The Common Rule is a uniform federal policy for the Protection of Human Subjects, originally issued in 1991. The U.S. agencies and departments adopting the Common Rule generally agree to the same set of basic protections to be applicable to human subject research activities they will conduct or support, but adopt such protections within their own applicable regulations. The NPRM is expected to appear in the September 8, 2015, issue of the Federal Register, and to be open for public comment through December 7, 2015.

Continue reading

Leave a comment

Filed under Clinical Trials, Compliance, FDA, Health Care

HHS OIG Approves Drug Company Program Providing Free Cancer Treatment Drugs

On Tuesday, the Health and Human Services (HHS) Office of Inspector General (OIG) issued an Advisory Opinion regarding a program to provide a 30-day supply of cancer drugs free of costs to patients who experience an insurance coverage determination delay of at least five business days (the Free Supply Program).  The OIG concluded that although the Free Supply Program could potentially generate prohibited remuneration under the federal health care program anti-kickback statute (AKS) (42 U.S.C. 1320a-7b(b), the OIG would not impose administrative sanctions against the two requestors, pharmaceutical companies that co-promote the drug, in connection with this arrangement.

Continue reading

Leave a comment

Filed under Advisory Opinions, OIG Guidance