FDA Law Blog

MARCH 9, 2023

Attorney’s Offices, and, importantly for readers of this blog, the Civil Division’s Consumer Protection Branch (CPB), will all consistently reward corporations that voluntarily disclose and remediate misconduct. Many federal agencies do have policies that provide a safe harbor for voluntary disclosures, but FDA does not.

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FDA Law Blog

MAY 7, 2025

Two recent cases from the Fifth and Seventh Circuits, however, support the legality of these arrangements in the absence of the government proving certain circumstances. Mallory , 988 F.3d 3d 730 (4th Cir. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th Polin , 194 F.3d

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FDA Law Blog

JANUARY 6, 2022

220 and was described on HP&M’s blog here. Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.”

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FDA Law Blog

AUGUST 4, 2022

The approval process, pre-approval concerns, product labeling, clinical trials, adverse events reports, patent concerns, and exclusivity – these are all critical aspects in the commercialization process for drugs and biologics that are governed by the FDA. UNDERSTAND the importance of cGMPs to the post-approval regulatory process.

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FDA Law Blog

NOVEMBER 6, 2022

Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. By Sophia R.

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FDA Law Blog

JANUARY 31, 2022

In addition, the Complaint alleges inappropriate dispensing to numerous individuals, multiple DEA recordkeeping violations, improper alteration of prescriptions, and violations Texas law and federal corresponding responsibility obligations required of pharmacists that dispense opioid prescriptions.

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FDA Law Blog

OCTOBER 13, 2024

Designed to incentivize the development of drugs for pediatric rare diseases where such development may not otherwise have occurred, vouchers may be granted for drugs for serious or life-threatening rare diseases where the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years.

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FDA Law Blog

JUNE 12, 2023

PFI expressed some of its frustration with the current state of regulation of pet food by individual states in its comments on the Center for Veterinary Medicine (CVM) Virtual Public Meeting FDA and the AAFCO Animal Feed Ingredient Definition Process. PFI has noted that it is not feasible to develop and label products for an individual state.

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FDA Law Blog

NOVEMBER 6, 2023

The LMG Life Sciences awards are based on case evidence and feedback from clients and peers and selected by the editors to provide attorneys and law firms with information on the legal market and the U.S. They range from individuals and start-up companies with no in-house legal staff to large multinational corporations.

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FDA Law Blog

JANUARY 6, 2022

220 and was described on HP&M’s blog here. Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.”

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FDA Law Blog

OCTOBER 10, 2022

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. Criterion 3 : Non-Device CDS software functions are intended for the purpose of supporting or providing recommendations about a patient’s care to a health care professional (HCP) user.

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FDA Law Blog

JANUARY 31, 2023

Of course, no patent counsel “worth their salt” would ever WANT to make a statement against their interest that they were incapable of coming up with any possible way to show that this drug’s use in treating a rare condition was indeed “new” and “not obvious”.

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FDA Law Blog

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 21 U.S.C. §

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FDA Law Blog

JUNE 27, 2024

Public Interest Factors The Controlled Substances Act provides that DEA may suspend or revoke a registration upon finding that the registrant has committed acts that would render the registration inconsistent with the public interest. The Government alleged that Coconut Grove violated numerous federal and state controlled substance laws.

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FDA Law Blog

NOVEMBER 2, 2023

These standards would be developed outside the Federal government, leveraging the expertise of the private sector. These meetings have a question-and-answer format to provide clarity to sponsors about the particular topics at hand.

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FDA Law Blog

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.

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FDA Law Blog

JUNE 16, 2023

The statement must itemize the cost components related to production of the drug, identify increases in materials or manufacturing costs, and provide other information that the manufacturer believes relevant to determining whether a violation has occurred. SF 2744 also provides a private right of action to enforce the prohibition.

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ABIM

JUNE 24, 2025

Visit the ABIM Blog for reports of prior meetings. Community Practice in ABIM Governance* Erica N. She also sought input on overlapping aspects of community practice across the disciplines of internal medicine to inform ABIM’s recruitment efforts for broad physician representation in governance roles.

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ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. Community Practice in ABIM Governance* Erica N. She also sought input on overlapping aspects of community practice across the disciplines of internal medicine to inform ABIM’s recruitment efforts for broad physician representation in governance roles.

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FDA Law Blog

NOVEMBER 14, 2021

But like James Bond, companies in the crosshairs of a government investigation have No Time to Die, as they answer to shareholders and fight for corporate survival. To receive such consideration, companies cannot limit disclosure to those individuals believed to be only substantially involved in the criminal conduct.

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FDA Law Blog

FEBRUARY 7, 2024

Gilbert — Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers, maintaining records, and filing reports of individuals selling/purchasing pill presses and encapsulating machines.

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FDA Law Blog

NOVEMBER 18, 2021

The tests are very accurate in detecting individuals with a relatively high viral load (symptomatic or not). On the minus side, a rapid antigen test may miss an infected individual with a low viral load (e.g., True, these tests will never provide the same diagnostic quality results as RT?PCR, A follow up laboratory?run

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FDA Law Blog

MARCH 15, 2023

See Government Accountability Office, “ GAO-06-724 Mammography: Current Nationwide Capacity Is Adequate, but Access Problems May Exist in Certain Locations ” (July 2006). Current regulations do not require breast density notification to be part of the healthcare provider report or the lay summary to the patient.

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FDA Law Blog

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. FDA will consider if technologies and device features “address unmet needs in these populations” when evaluating criterion one.

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FDA Law Blog

APRIL 8, 2024

MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. Unfortunately, the White Paper does not provide further analysis on the generic sterile injectables and instead refers back to FDA’s analysis from 2013-2017. surgical robots, MRIs)?

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GeriPal

JANUARY 11, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Eric: Yeah.

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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. Best Price Stacking We previously blogged about the 4 th Circuit Court of Appeals decision in United States Ex Rel. Sheldon, v.

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FDA Law Blog

SEPTEMBER 6, 2021

Though the carve-out seems at odds with FDA’s regulations requiring generic drugs to have the “same labeling” as their RLDs, such regulations specifically provide for differences arising from carved-out, patent-protected method of use. The catch is, as we have learned from the GSK v.

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GeriPal

MARCH 16, 2023

So this week we’re going to be talking about writing for the lay public, and next week we’ll be publishing a podcast on writing for healthcare providers. And then I feel like when I’m in clinic I’m helping individuals, and you only have so much time to help so many people. Rosanne: I certainly do.

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FDA Law Blog

FEBRUARY 11, 2024

The three letters together provide the range of actions DEA may take: no rescheduling from schedule I (former drug officials), rescheduling to schedule III (Democratic state attorneys general), or descheduling altogether (Democratic senators). (We We blogged on the December 5, 2023, letter from six Democratic governors to President Biden).

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FDA Law Blog

AUGUST 3, 2021

CMS estimated that the rule would result in savings in individual out-of-pocket costs but such savings would be more than offset by increased premiums. The rule was estimated to cost the federal government around $196 billion over ten years. See bipartisan bill summary at 5.

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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. A manufacturer that failed to provide access to the MFP would be subject to a civil monetary penalty of ten times the excessive price charged. Subtitle E is a slightly modified version of H.R.

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FDA Law Blog

MAY 26, 2025

Specifically, these are procedures and drugs used in providing what HHS had, until recently, referred to as gender-affirming care. Department of Health & Human Services purporting to provide a comprehensive review of the evidence and best practices for promoting the health of children and adolescents with gender dysphoria.

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FDA Law Blog

MAY 12, 2025

Kirschenbaum On September 15, 2020, I posted an article in this blog entitled Trump Embraces International Reference Pricing in Executive Order, which described an order in Trumps first administration to use most-favored-nation (MFN) pricing as a limit on Medicare payment. So far, only Florida has obtained FDA authorization to operate a SIP.)

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FDA Law Blog

SEPTEMBER 13, 2021

Currently, individual Medicare Part D plan sponsors negotiate rebates but the government is explicitly prohibited from interfering in those negotiations. The attraction of the repeal is that Part D negotiations can potentially save the federal government “hundreds of billions of dollars,” as explained in the Plan.

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