FDA Law

DECEMBER 4, 2023

The government asserted additional allegations that are outside our scope. Pharmacists’ Corresponding Responsibility A controlled substance prescription, to be valid, must be issued for “a legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” Zarzamora Press Release.

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Treatment Plan ER Government Patient-Centered 139

FDA Law

JUNE 6, 2022

As faithful readers of our blog know, FDA’s broad interpretations of its governing statute have not always fared that well in the courts. While industry has been celebrating its judicial success, FDA has been quietly lobbying Congress to revise its governing statutes to reverse the agency’s losses. FDA , Catalyst Pharms.,

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IT Government Education Medical 98

ABIM

APRIL 24, 2025

Visit the ABIM Blog for reports of prior meetings. Chrostowski, DNP, APR-N, ANP-C , asked whether ABIM will offer continuing medical education (CME) credits through the LKA. Thousands of activities are eligible for both MOC and CME via a collaboration with the Accreditation Council for Continuing Medical Education at cmepassport.org.

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Board-Certified Board-Certified Physicians Community Government 40

FDA Law

JUNE 28, 2022

This consolidated case has implications not only for prescribers of controlled substances but also for pharmacists and pharmacies who are subject to a “corresponding responsibility” to only fill prescriptions issued for a legitimate medical purpose pursuant to the Controlled Substances Act (21 U.S.C. § United States, No. 21 U.S.C. §

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Government Manufacturing Medical IT 98

FDA Law

AUGUST 4, 2022

In September 2020, the Agency issued an unfavorable advisory opinion to Pfizer, concluding that the proposal was “highly suspect” under the AKS “because one purpose of the [proposed program]—perhaps the primary purpose—would be to induce Medicare beneficiaries to purchase [Pfizer’s] federally reimbursable Medications.”

Manufacturing 98

Manufacturing Medical Government IT 98

FDA Law

MAY 9, 2023

The risks she described caught our attention because two of the risk profiles she cited included things that touched on FDA-related entities, such as medical devices that transmit data. The news wasn’t all bad for the government, but FTC’s now has some decisions to make. So, the government here has a choice to make.

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Medical Government IT Relationship 59

FDA Law

NOVEMBER 15, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — In our last blog post , we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. In this blog post, we provide a primer on user fees and the Small Business Program.

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Medical Provider IT Manufacturing 59

FDA Law

SEPTEMBER 30, 2021

And the “David” cast of characters has successfully challenged FDA’s promulgation of its final Memorandum of Understanding (“MOU”) intended to “address” shipments of compounded medications interstate. See Federal Food, Drug, and Cosmetic Act (“FDCA”) Section 503A(b)(2).

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Board-Certified IT Government Individual 98

FDA Law

FEBRUARY 20, 2023

This case was the latest example of government regulators punishing a company that refused to live up to its promises of consumer data protection. That’s a good list of the kinds of things that most consumers really do not want their digital medical services provider to do with their sensitive personal information.

Patient-Centered 105

Patient-Centered Telehealth IT Government 105

FDA Law

JULY 30, 2024

By Sara M Keup & Véronique Li, Senior Medical Device Regulation Expert — The American Conference Institute (“ACI”) held its 11th Annual Summit for Women Leaders in Life Sciences Law at the Seaport Hotel in Boston, Massachusetts on July 25th & 26th of last week. Women in Government and Judiciary Roundtable.

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Government Medical IT 52

FDA Law

MARCH 12, 2023

These government measures included granting temporary exemptions from certain FDA and DEA legal requirements. By almost all accounts, these exemptions also improved prescribing and dispensing of medication to patients that need them. When the public health emergency ends on May 11, 2023 , so do these exemptions.

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Telemedicine Government Patients Medical 98

FDA Law

MARCH 4, 2024

This essential event for regulatory professionals in the biopharmaceutical and medical device industries will take place March 12-13, 2024, in Arlington, VA. FDA Law Blog readers can use the discount code 24SPKR150 for reduced registration fees.

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Government Provider Medical 59

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.

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Manufacturing Government Consulting IT 102

FDA Law

OCTOBER 8, 2023

As a reminder, back in February 2023, HPM blogged about DEA’s two proposed rules for prescribing (1) controlled substances generally and (2) for buprenorphine use in opioid treatment. Temporary Rule: Second Temporary Extension of COVID–19 Telemedicine Flexibilities for Prescription of Controlled Medications, 88 Fed.

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Telemedicine Relationship IT Mental Health 64

FDA Law

SEPTEMBER 28, 2021

Richardson — On September 24, 2021, the owner of a pharmacy in Puerto Rico pleaded guilty to participating in a felony conspiracy to convert government property and to commit health care fraud in connection with the illegal vaccination of minors between the ages of 7 to 11 with the Pfizer-BioNTech COVID-19 vaccine. By Kalie E.

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Vaccination Individual Government Provider 98

FDA Law

SEPTEMBER 22, 2022

While the authors did a yeoman’s job of combing through the criminal cases to identify what they view as a “handful” of cases and call for increased use of the Park doctrine, we at the FDA Law Blog respectfully disagree. The JAMA editorial notes that there are few Park cases for two primary reasons: [The government] may lead.

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Private Practice Government Individual Specialization 59

FDA Law

FEBRUARY 13, 2025

Baumhardt, Principal Medical Device Regulatory Expert FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSF).

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Manufacturing Management Specialization Provider 71

FDA Law

NOVEMBER 6, 2023

Admittedly, BiMo inspections (into items like adequacy of bioequivalence data, consistency of clinical trial data with medical records, and compliance with clinical trial protocols) lend themselves better to an RIE than assessing manufacturing compliance with regulatory requirements. We should explain what RIEs are.

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Manufacturing Clinic IT Utilities 105

FDA Law

JANUARY 28, 2024

FDA points to a nearly 50-year-old statute, the Medical Device Amendments (MDA), as the source of its supposed authority to regulate LDTs as medical devices—authority which it apparently chose to not enforce until now. But, as we detail in the WLF publication: “ the MDA supplies no such clear [congressional authorization].

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Government Medical Management IT 64

ABIM

MAY 18, 2025

Without a full understanding of the disease context, he recommended surgery that, in hindsight, was not the medically appropriate next step. We need not only your medical expertise, but also empathy, cultural humility, and a willingness to look beyond what’s visible. I often reflect on those years because they were the most traumatic.

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Diagnose Healthcare Diagnosis Physicals 40

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. By Steven J. Gonzalez & Allyson B.

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IT Manufacturing Government Clinic 64

FDA Law

FEBRUARY 18, 2025

While on paper the respective credentials of each of the experts would indicate a balance of authority, or maybe even weigh in favor of the pharmacys expert (DEAs expert had prior disciplinary history), the ALJ and DEA Administrator each found the testimony of the governments expert more credible. Whats the take away?

Government 69

Government Specialization Patients IT 69

FDA Law

APRIL 19, 2021

We have blogged recently about several FDA setbacks in court ( here , for example). Genus Medical Technologies secured an important victory in the D.C. In Genus Medical Technologies v. The decision has wide-ranging implications for FDA’s assertion of discretion in classifying and regulating medical products.

Manufacturing 40

Manufacturing Government Medical IT 40

FDA Law

JUNE 8, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — On May 11, 2023, the U.S. The pandemic also deeply impacted how industry and the government conduct their operations. The pandemic also deeply impacted how industry and the government conduct their operations. However, not all changes are forever.

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Relationship Government Screening Medical 53

FDA Law

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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Clinic Clinical Practice Provider Utilities 64

FDA Law

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.

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83

FDA Law

MAY 7, 2025

Gonzalez There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. In that decision, a medical laboratory paid Marchetti percentage-based compensation for successful referrals of Medicare patients to the laboratory.

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Referral Relationship Government Healthcare 59

FDA Law

JANUARY 31, 2022

The United States filed a Complaint against Texas entities Zarzamora Healthcare LLC, Rite-Away Pharmacy and Medical Supply #2– and its Pharmacist-in-Charge (PIC), and part owner. Because the Government also failed to provide the Court a written certification in order to comply with Fed. 21 U.S.C. §

Government 40

Government IT Provider Healthcare 40

FDA Law

OCTOBER 25, 2021

The Medical Device Amendments of 1976 created the initial premarket application (PMA) review and 510(k) substantial equivalence review processes. Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. befitted a very important pathway to market for novel medical devices. Part 860.

Manufacturing 52

Manufacturing Government Specialization IT 52

FDA Law

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. § 812(c)(c)(10).

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Government Medical IT Manufacturing 59

FDA Law

JANUARY 12, 2025

FDAs interpretation of several threshold criteria for eligibility (serious condition, available therapy, unmet medical need) will continue to rely upon the 2014 Guidance. As such, we will publish a separate blog post focused on confirmatory trials and how FDA is interpreting this key provision of its accelerated approval authority.

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Clinic Relationship Provider IT 64

FDA Law

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. Specifically, the guidance interprets the Cures Act’s four criteria for exclusion of CDS software functions from FDA’s medical device jurisdiction (so-called “Non-Device CDS”).

Clinic 52

Clinic Medical Provider Patients 52

FDA Law

FEBRUARY 26, 2024

With over 26 years of dedicated service to the pharmaceutical and medical device industries, Ms. Walsh has garnered acclaim for her passionate efforts in assisting companies with preventing or responding to government investigations, conducting internal investigations to ensure compliance, and defending against DOJ prosecutions.

Government 59

Government IT Medical 59

FDA Law

SEPTEMBER 17, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — Over the last three and a half years, meetings with FDA were conducted virtually. Inside Building 66 Upon arriving at Building 66, all visitors must present government-issued photo identification for check-in.

Screening 59

Screening Transportation Provider Electronics 59

FDA Law

MAY 19, 2025

For a controlled substance prescription to be effective, that is valid, it must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of their professional practice. Attorneys Office, Northern District of Illinois, April 21, 2025. Complaint, 82. 81, 86, 251.

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Individual Patients Provider Medical 64

FDA Law

DECEMBER 22, 2022

That, of course, is reserved for the practice of medicine, and FDA does not govern the practice of medicine. Previously, FDA determined whether a product was safe and effective for its intended use but could not dictate the way a practitioner used that product.

Patient-Centered 114

Patient-Centered Education Government IT 114

FDA Law

AUGUST 15, 2021

Shapiro — A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices. FDA has now issued a final rule governing how intended use of a distributed product is to be determined. It is embodied in parallel drug and device regulatory definitions of intended use (21 C.F.R. §§ 201.128 (drugs), 801.4

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Manufacturing IT Provider Government 93