Blog, Clinic, Government and Manufacturing

Lots of FDA Guidance, But Few Drug Manufacturing “Remote Interactive Evaluations” (We Would Call Them “Virtual Inspections”)

FDA Law

NOVEMBER 6, 2023

A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections.

Manufacturing

Manufacturing Clinic IT Utilities

D.C. Circuit Sides with Manufacturers in Latest 340B Contract Pharmacy Case

FDA Law

MAY 30, 2024

Kirschenbaum — Last week, the United States Court of Appeals for the District of Columbia ruled that Section 340B of the Public Health Service Act does not prohibit pharmaceutical manufacturers from imposing conditions on the distribution of discounted drugs to covered entities in the program. In United Therapeutics Corporation v.

Manufacturing

Manufacturing Patient-Centered Government Hospital

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Law

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” In brief, such devices can be commercially distributed to the general public for non-medical purposes without FDA regulation (e.g., products intended for medical purposes).

Medical

Medical Manufacturing Healthcare Government

GAO Report on Clinical Research Inspections Encourages FDA to Care for its Clinical Inspection Program

FDA Law

MARCH 29, 2024

Many have noted that FDA has been slow to recover We’ve blogged before on FDA’s post-pandemic inspection work, writing about the resumption of both good manufacturing practice (GMP) and bioresearch monitoring (BIMO) inspections. In other words, the inspectional output was inversely proportional to the importance of clinical research.

Clinic

Clinic IT Manufacturing Government

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Law

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” In brief, such devices can be commercially distributed to the general public for non-medical purposes without FDA regulation (e.g., products intended for medical purposes).

Medical

Medical Manufacturing Healthcare Government

The Most Engaging Decision You’ll Read All Year – Five Stars

FDA Law

JANUARY 15, 2024

Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. FDA extended PMTA compliance deadlines for years so it could figure out appropriate application instructions and so that manufacturers could figure out how to comply.

Manufacturing

Manufacturing IT Provider ER

Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

FDA Law

AUGUST 4, 2022

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. That court granted summary judgment to the government on the APA claim and rejected Pfizer’s narrower reading of the AKS, which would require an element of “corrupt” intent to impose AKS liability.

Manufacturing

Manufacturing Medical Government IT

Keeping Your Company’s Federal Contracting Options Safe in the Face of Pending BIOSECURE Act Legislation

FDA Law

MARCH 3, 2024

This proposed legislation should be of interest to any biotechnology companies that want to do business with the federal government in the future. Scope Part 2 —Is reimbursement under Medicaid a grant of funds by the federal government, such that they are governed by the Act? House of Representatives ( H.B.

Manufacturing

Manufacturing Government Consulting IT

Vanda-lay Litigation Industries, Inc.: Taking Stock of Vanda Pharmaceuticals, Inc.’s Big Bets on Petitioning and Litigation Against FDA and the Federal Government

FDA Law

OCTOBER 1, 2024

District Court for the District of Columbia (“DDC”) against FDA alleging that the Agency’s structure of NDA review is unconstitutional (by our count the 31st Vanda litigation against FDA or another government entity in the last five years, including appeals). VANDA PHARMACEUTICALS, INC. VANDA PHARMACEUTICALS, INC. 1:2022cv00938 (D.D.C.)

Government

Government Appointment Manufacturing IT

FDA Abandons Its Defense of the LDT Rule, But is It Signaling an Increase in RUO Scrutiny?

FDA Law

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so. RUO-labeled reagents and materials are often used in LDTs in clinical laboratories. By Steven J.

IT

IT Manufacturing Government Clinic

The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

FDA Law

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. You can find our preliminary blog post on the release of this guidance here , and our blog posts on the draft CDS guidances here and here.

Clinic

Clinic Medical Provider Patients

News on FDA’s Quality Management Maturity Program-Maturity to Continually Improve and to not be Reactive

FDA Law

MARCH 1, 2023

FDA published two Federal Register Notices in October 2020 to recruit domestic drug product manufacturers of finished dosage forms and foreign manufacturers of active pharmaceutical ingredients to participate in the QMM Pilot Programs. FDA describes the QMM as “above-the-bar behaviors” that exceed good manufacturing practices (GMPs).

Management

Management Manufacturing Supply Chain Provider

FDA Publishes De Novo Classification Final Rule with Few Changes from the Proposed Rule

FDA Law

OCTOBER 25, 2021

Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. Yet, all this time, this process lacked implementing regulations governing the process and the criteria for approval. Part 807, Subpart E). In 1986, FDA followed up with the PMA regulations (21 C.F.R. The regulatory uncertainty has ill?befitted

Manufacturing

Manufacturing Specialization Government IT

The 340B Showdown: HRSA Proceeds Towards Enforcement Despite Litigation

FDA Law

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

Manufacturing

Manufacturing Government Referral Provider

Price Limits, Affordability Boards, Penalties, Oh My: Minnesota Enacts Sweeping Drug Pricing Reforms

FDA Law

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below. Best price?

Manufacturing

Manufacturing Provider Consulting IT

Answers to the Most Frequently Asked Questions about the Previous Answers to the Most Frequently Asked Questions about Charging for Investigational Drugs

FDA Law

SEPTEMBER 6, 2022

As the new Federal Register notice explains, FDA issued the 2016 Guidance in question and answer format to respond to the most frequently asked questions about charging for investigational drugs provided under an IND for either clinical trials or expanded access for treatment use under 21 CFR section 312.8. Changes from the 2016 Guidance.

Clinic

Clinic Manufacturing Patients IT

As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement

FDA Law

JANUARY 5, 2023

It is another effort from CDRH’s Digital Health Center of Excellence to provide structure and guidance to participants across the connected device playing field, including both delivery organizations as well as manufacturers. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.

Manufacturing

Manufacturing Patient-Centered Provider Telehealth

FDA Would Like to Join You in the Sandbox When Developing AI Enabled Devices

FDA Law

MARCH 6, 2025

We were struck by the level of detail expected by FDA for processes related to data management, especially for data collected and used early in development to train an initial AI model, which may occur before a manufacturer decides to move forward with device development under design controls. data acquisition device).

Manufacturing

Manufacturing Management Clinical Practice Clinic

It’s My Party and I’ll Cry if I Want to: A Bittersweet Happy 30th Birthday to LDTs

FDA Law

AUGUST 3, 2022

3, 1992) (“It has come to the attention of FDA that laboratories have been manufacturing, “home brew” products, either from products already on the market, or from components, and utilizing these unapproved products for diagnostic purposes. As we began to prepare this blog, we thought it might be both birthday card and death notice for LDTs.

Lab Testing

Lab Testing Government IT Manufacturing

Where Are All the OTC Rapid Antigen Tests for COVID? FDA’s Role in Blocking These Tests from the American Market

FDA Law

NOVEMBER 18, 2021

Rapid tests for COVID-19 are fast, inexpensive to manufacture, and a relatively easy method to detect the presence of an active SARS?CoV?2 This capacity limitation does not apply to OTC lateral flow antigen tests, which can be manufactured in the hundreds of millions per month at a much lower cost than RT?PCR Why is that? Background.

Screening

Screening Manufacturing Healthcare IT

Does the Drug Shortage White Paper Fall Short?

FDA Law

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. The proposed Manufacturing Resiliency Assessment Program (MRAP) would be managed as a public-private partnership and would assign resilience scores to manufacturers of generic drugs, “based on an assessment of manufacturer practices and past performance.”

Supply Chain

Supply Chain Manufacturing Government Hospital

New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations

FDA Law

OCTOBER 17, 2023

In October 2022, FDA released the draft guidance entitled “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare,” as previously discussed in our blog. If FDA’s evidentiary expectations are set too high, it could undermine the intent of the new guidance.

Medical

Medical Diagnosis Healthcare Clinic

The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law

JUNE 4, 2025

Ordinarily, a public health initiative of such magnitude would have been governed by a transparent multi-step process featuring public meetings and drawing on external scientific expertise. In other words, as you read this, the Assessments findings and recommendations are getting baked into federal government policy, for better or worse.

Chronic Disease

Chronic Disease Government Chronic Condition Clinic

CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

FDA Law

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers.

Manufacturing

Manufacturing Vaccination Government Diagnosis

Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument

FDA Law

FEBRUARY 20, 2025

On February 19, 2025, Judge Sean Jordan in the Eastern District of Texas heard oral arguments in American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathologys (AMP) [1] lawsuit against the Department of Health and Human Services. Perhaps most notable in yesterdays argument, though, was what didnt happen.

Patient-Centered

Patient-Centered Consulting Government Clinic

Senator Durbin Has Questions About FDA’s “Operational Capacity” to Oversee DTC Prescription Drug Advertising Amid Workforce Reductions – Don’t We All?

FDA Law

JUNE 1, 2025

Government Accountability Office (GAO) published a report finding that, for the years 2016-2018, the pharmaceutical industry spent on average for a sample of 553 drug products approximately $6 billion annually on DTC advertisements, with a significant portion of this spending allocated to television commercials. In 2021, the U.S.

Healthcare Professional

Healthcare Professional Manufacturing Healthcare Utilities

Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

FDA Law

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.

Manufacturing

Manufacturing Supply Chain Patient-Centered Utilities

Primary Care Digest

Lots of FDA Guidance, But Few Drug Manufacturing “Remote Interactive Evaluations” (We Would Call Them “Virtual Inspections”)

D.C. Circuit Sides with Manufacturers in Latest 340B Contract Pharmacy Case

Trending Sources

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

GAO Report on Clinical Research Inspections Encourages FDA to Care for its Clinical Inspection Program

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

The Most Engaging Decision You’ll Read All Year – Five Stars

Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

Keeping Your Company’s Federal Contracting Options Safe in the Face of Pending BIOSECURE Act Legislation

Vanda-lay Litigation Industries, Inc.: Taking Stock of Vanda Pharmaceuticals, Inc.’s Big Bets on Petitioning and Litigation Against FDA and the Federal Government

FDA Abandons Its Defense of the LDT Rule, But is It Signaling an Increase in RUO Scrutiny?

The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

News on FDA’s Quality Management Maturity Program-Maturity to Continually Improve and to not be Reactive

FDA Publishes De Novo Classification Final Rule with Few Changes from the Proposed Rule

The 340B Showdown: HRSA Proceeds Towards Enforcement Despite Litigation

Price Limits, Affordability Boards, Penalties, Oh My: Minnesota Enacts Sweeping Drug Pricing Reforms

Answers to the Most Frequently Asked Questions about the Previous Answers to the Most Frequently Asked Questions about Charging for Investigational Drugs

As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement

FDA Would Like to Join You in the Sandbox When Developing AI Enabled Devices

It’s My Party and I’ll Cry if I Want to: A Bittersweet Happy 30th Birthday to LDTs

Where Are All the OTC Rapid Antigen Tests for COVID? FDA’s Role in Blocking These Tests from the American Market

Does the Drug Shortage White Paper Fall Short?

New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations

The MAHA Assessment’s Implications: Drugs (Part One)

CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument

Senator Durbin Has Questions About FDA’s “Operational Capacity” to Oversee DTC Prescription Drug Advertising Amid Workforce Reductions – Don’t We All?

Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

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