FDA Law Blog

NOVEMBER 6, 2022

The Court found that there is at best little utility in interpreting the AKS by reference to the BIS. As Pfizer has argued throughout this legal battle, its proposed copay assistance program “poses no risk of corrupting independent decision making” or of inducing improper utilization of tafamidis. Pfizer’s Petition to SCOTUS.

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83

FDA Law Blog

OCTOBER 24, 2023

Firm-generated communications must meet the general recommendations in the Draft Guidance and “should be truthful, non-misleading, factual and unbiased and provide all information necessary for HCPs to interpret the strengths and weaknesses and validity and utility of the presented information.”

Clinic 64

Clinic Clinical Practice Provider Utilities 64

FDA Law Blog

JULY 17, 2022

Currently, a health care provider identifies any discarded quantity from such a vial in the claim using a JW modifier, and Medicare Part B pays for both the utilized and the discarded amount. The manufacturer responsible for paying the refunds will be the company whose NDC is on the label.

Manufacturing 52

Manufacturing Utilities Government Provider 52

Permanente Medicine

MAY 20, 2025

These priorities include supporting the physician workforce, utilizing data and predictive interventions to improve patient outcomes, and boosting quality and affordability for patients. I know for a fact that the government or legislators looked to us in Permanente. And then putting that on steroids with AI.

Patient-Centered 52

Patient-Centered Patients Medical IT 52

GeriPal

JUNE 26, 2025

And the government can do something about that?!? And it was her conceptual, like incorporation of functional decline, some measure of functional decline along with a serious illness diagnosis that you’re utilizing here. So that’s the macro environment and the role in this government policies, how this could play a role.

Illness 60

Illness Hospital IT Patient-Centered 60

FDA Law Blog

FEBRUARY 2, 2023

Alternative methods will require significant research investment to demonstrate their utility for a particular context of use and inform regulatory decision-making. FDORA replaces the language in (bb) regarding animal studies with “an assessment of toxicity (which may rely on, or consist of, a study or studies described in item (aa) or (cc).”

Clinic 64

Clinic IT Utilities Government 64

FDA Law Blog

JUNE 22, 2022

This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. Department of Justice (“DOJ”), Sovah Health to Pay United States $4.36 Million to Settle Claims of Controlled Substance Act Violations (June 8, 2022).

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FDA Law Blog

JUNE 27, 2024

The Government alleged that Coconut Grove violated numerous federal and state controlled substance laws. Factor B was the pharmacy’s experience with dispensing or conducting research with respect to controlled substances while Factor D was compliance with applicable state, federal, or local laws relating to controlled substances.

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Insurance Patients Utilities Chronic Condition 52

FDA Law Blog

JULY 13, 2022

If the biosimilar has not been licensed and marketed within the approved delay period (either 1 or 2 years depending on likelihood of licensure), the manufacturer of the biological product must pay a rebate to the government for the lost savings due to the delay. Each product is limited to two years of delay.

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IT Manufacturing Utilities Complication 52

FDA Law Blog

MARCH 20, 2022

FDA has model recall communication templates available here that firms can utilize. Most FDA-regulated entities have an established SOP that governs the evaluation, decision, notification, and process for conducting a recall.

Electronics 40

Electronics Manufacturing Provider IT 40

FDA Law Blog

NOVEMBER 15, 2022

Any application from a State or Federal Government entity. To reduce the chances of inefficiencies with delivery and processing, we recommend utilizing eSTAR to submit your applications to FDA. One-time first submission fee waiver for a small business with gross receipts of sales $30 million or less. Suggestion for FDA.

Medical 59

Medical Provider IT Manufacturing 59

FDA Law Blog

JUNE 16, 2023

Identified drugs and related price information will be publicly disclosed, except for information the Board determines to be proprietary, not public, or trade secret. The Board may then initiate a cost review of any such identified drug product.

Manufacturing 45

Manufacturing Provider Consulting IT 45

GeriPal

JULY 19, 2024

So I think we’re poised now with the guide model and with the evidence we have about healthcare utilization, impact on caregivers, course of dementia, comorbidity management and all of that. I don’t have access to change the levers of government. Eric 19:56 Okay, but I’m a primary care provider. But I don’t.

Screening 120

Screening Primary Care Patient-Centered IT 120

FDA Law Blog

MAY 11, 2023

government in the now-infamous (at least in FDA circles) Teva v. In the brief , the Government takes a strong position, stating “[t]he court of appeals’ holding that respondents presented sufficient evidence of petitioner’s intent to induce infringement is erroneous and warrants this Court’s review.” GSK skinny label case , the U.S.

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Government Manufacturing IT Utilities 72

FDA Law Blog

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. These products are subject to the same regulatory requirements as any unapproved medical device”).

Lab Testing 98

Lab Testing Government IT Manufacturing 98

PEMBlog

MAY 24, 2023

This entails utilizing the least invasive non-pharmacologic means of assisting them, before moving to physical or chemical restraints. Government. Patient that are agitated should always be treated with dignity and respect.

Management 55

Management Patient-Centered Physicals Finance 55

GeriPal

JANUARY 20, 2023

There have been multiple subsequent government reports on nursing home care, most recently was about eight, nine years ago from the OIG. Part of it’s what Mike was saying, it’s accountability as a country, as a nation and as the government. This is a problem that’s existed for decades. What are they accountable for?

Finance 95

Finance Board-Certified IT Provider 95

FDA Law Blog

NOVEMBER 16, 2021

Congressional proponents of this provision argued that manufacturers have been deliberately overfilling single-use drug containers to permit their customers to obtain greater reimbursement, and have profited from the resulting increase in utilization of the drug.

Manufacturing 40

Manufacturing Utilities Management Provider 40

FDA Law Blog

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 59

Manufacturing Vaccination Government Diagnosis 59

FDA Law Blog

SEPTEMBER 6, 2021

Teva case, that the statutory provisions governing patent infringement, specifically induced infringement, do not address carve-outs. Especially now with the utility of the use code minimized. The catch is, as we have learned from the GSK v. But what is a “true carve-out?”

IT 52

IT Provider ER Insurance 52

GeriPal

JULY 6, 2023

I think to some extent, the county doesn’t necessarily know what they don’t know about geriatrics, just like I don’t necessarily know what I don’t know about the county and local government and national government and state government. We’re in about year two right now.

Community 89

Community Nurse Practitioner Provider IT 89

FDA Law Blog

AUGUST 14, 2022

With one recent and minor exception (see our blogpost here ), all of the government discount and rebate programs heretofore have been founded on agreements between the government and manufacturers. Manufacturers receive no benefits in exchange for the inflation rebates.

Manufacturing 98

Manufacturing Government Vaccination Utilities 98

GeriPal

DECEMBER 21, 2023

The typical utilization of inappropriate hospitalization and emergency room and total cost of care. Just to let you know, Eric, we have to give the credit to our federal government. Our alliance is governed by a steering committee and we go to them and say what are the areas? We have to demonstrate we can do that. Diane: Yeah.

Patient-Centered 126

Patient-Centered IT Families Family 126

FDA Law Blog

SEPTEMBER 14, 2021

This bill, which addresses numerous areas of the economy, public health, and government regulation, includes Subtitle E, Drug Pricing. Subtitle E is a slightly modified version of H.R. 3, the Elijah E. The AIM price is the volume-weighted average price of the drug in Australia, Canada, France, Germany, Japan, and the U.K.

Manufacturing 52

Manufacturing Insurance Government Patients 52

FDA Law Blog

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 59

Healthcare Professional Manufacturing Healthcare Utilities 59

GeriPal

JULY 20, 2023

We were the highest utilizers of telemedicine in the whole UCSF health system at that time which we’re very proud of. ” And I could tell you that’s a lot for a government agency to hear. I think at least we like to think of ourselves as ahead of the curve. We hear that all the time now.

Telemedicine 73

Telemedicine Telehealth Patient-Centered Board-Certified 73

Doctors for America

APRIL 29, 2025

We hope that Commissioner Makary will utilize his experience to help ensure FDA puts patients over politics throughout his tenure. Both Secretary Kennedy and Commissioner Makary have proposed strategies to mitigate the “revolving door” between the government and the industries they regulate.

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Medical Student Patients Medical Individual 52

FDA Law Blog

SEPTEMBER 13, 2021

Medicare negotiation authority; encourage biosimilars and generic drug utilization). Currently, individual Medicare Part D plan sponsors negotiate rebates but the government is explicitly prohibited from interfering in those negotiations. Controlling Medicare Part D Patient Out-of-Pocket Costs and Total Drug Costs.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98