FDA Law Blog

MARCH 5, 2024

First, AstraZeneca alleged that CMS improperly defined a “qualifying single source drug” to include all dosage forms and strengths of the drug marketed by the manufacturer with the same active moiety or ingredient—even if those different forms and strengths were approved under different NDAs. 16 June 2023) Eliquis Novartis D.N.J. (1

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FDA Law Blog

JULY 17, 2022

Under the new law, Part B will continue to pay for discarded amounts from single-dose containers, but the manufacturer must pay a rebate (called a “refund”) to Medicare for discarded amounts above a specified threshold. Refunds will be payable for single-dose container drugs beginning on January 1, 2023.

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FDA Law Blog

JANUARY 18, 2023

They are: Terms and conditions of the manufacturer agreement, including each party’s responsibilities. Approach for considering (1) the manufacturer-reported data elements and (2) evidence about alternative treatments. Process for the offer and counteroffer exchange between the Secretary and manufacturers.

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FDA Law Blog

FEBRUARY 11, 2025

Gaulkin Drug manufacturers wont be receiving their first invoices for Medicare Part B and Part D inflation rebates until later this year, but rebates have been accruing since first quarter 2023 for Part B rebates and October 2022 for Part D rebates. Kirschenbaum & Sophia R.

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FDA Law Blog

MARCH 1, 2023

Brevig, Senior Regulatory Device and Biologics Expert — In January 2023, FDA published a paper summarizing its lessons learned from two pilot Quality Management Maturity (QMM) Pilot Programs, such as best practices for conducting QMM assessments and developing the QMM scoring system. By Holly N.

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FDA Law Blog

JUNE 26, 2023

Chamber of Commerce (complaint here ), in New Jersey by Bristol Myers Squibb (complaint here ), and in Texas by Pharmaceutical Research and Manufacturers of America (PhRMA) and others (complaint here ). Since then, complaints have been filed in federal court in Ohio by the U.S.

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FDA Law Blog

JANUARY 11, 2024

Koblitz — Back in late September 2023 (and corrected in October), FDA issued its first interchangeable exclusivity determination pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”). Notably, the purpose of the statute seemed to govern much of FDA’s interpretation. This all sounds complicated, I know.

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FDA Law Blog

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 2022, the Government Accountability Office reported that FDA needed to improve its foreign inspection program.

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FDA Law Blog

OCTOBER 4, 2023

According to the court, the Constitution guarantees no right to conduct business with the government, so the consequences of that participation can be “conditioned by regulation” without being considered unconstitutional. The drug was indeed selected on August 29, 2023.

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FDA Law Blog

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.

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FDA Law Blog

JUNE 12, 2023

As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee. They have inspectors in the field everyday with eyes on the products, on the local manufactures, and on the distributors and retailers.

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FDA Law Blog

FEBRUARY 27, 2023

In an erratum filed to the deposition of an official previously self-identified as the Chief FOIA Officer, the government stated that the individual was in fact, not the Chief FOIA Officer for DEA but Chief of the FOIA/PA Unit at DEA. Aims Institute, PLLC, v. Merrick Garland, et. al , Case No. 4:2022-cv-02396 S.D.

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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. § 812 (b)(1).

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FDA Law Blog

NOVEMBER 15, 2022

Any application from a State or Federal Government entity. BLA for product licensed for further manufacturing use only. The small business fees for FY 2023 can be found here. If you would like to request for FY 2023 status, you can submit an application through September 30, 2023. Third-party review. Not eligible.

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FDA Law Blog

MARCH 30, 2022

Earlier this week, FDA issued its Fiscal Year 2023 Budget Justification and related documents. Among the various documents, a document titled “ Executive Summary of FY 2023 Legislative Proposals ” caught our attention. But before we get back to “the Good” again, let’s take a look at “the Bad” and “the Ugly”.

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FDA Law Blog

AUGUST 17, 2022

This is important because self-fitting hearing aids require the submission and clearance of a 510(k) while regular OTC hearing aids do not, which provides incentive for manufacturers to self-classify their hearing aid products as regular OTC rather than self-fitting. (FYI, The preemption provisions, for example, have not changed.

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FDA Law Blog

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.”

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FDA Law Blog

NOVEMBER 16, 2021

The effective date of the amendments had already been delayed until January 1, 2023 pursuant to court orders in a lawsuit brought by the PBM industry association. In addition, section 90004 of the Act requires manufactures of drugs sold in single-dose containers to pay refunds to Medicare for discarded Part B drugs.

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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. Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers.

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FDA Law Blog

OCTOBER 17, 2023

The new guidance also presents an opportunity for device manufacturers working for patient populations affected by rare life-threatening or irreversibly debilitating diseases or conditions, such as sickle cell disease. By Philip Won & Lisa M.

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FDA Law Blog

AUGUST 14, 2022

The negotiations will result in a Maximum Fair Price (“MFP”) that the manufacturer must make available to providers furnishing the drug under Medicare Part B or pharmacies dispensing the drug under Part D. The same will be required under state Medicaid and CHIP programs by October 1, 2023.

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FDA Law Blog

JANUARY 24, 2024

Fast-forward to March 2023, when The White House OSTP issued a document per Executive Order 14081, titled “ Bold Goals for U.S. That’s a pretty lofty API manufacturing goal, but one that the API Innovation Center (“APIIC”) was charged to take up, consider, and propose some possible solutions. And so in November 2023 in St.

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FDA Law Blog

AUGUST 3, 2021

Department of Health and Human Services in December 2020 to prevent Medicare Part D and Medicaid Managed Care plans from receiving rebates from manufacturers unless the rebates are passed through to pharmacies to reduce patient out-of-pocket expenses. The rule was estimated to cost the federal government around $196 billion over ten years.

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FDA Law Blog

JUNE 27, 2022

If and when implemented, the amendments will likely force Medicare Part D plans and their PBMs to pass drug manufacturer rebates through to pharmacies to reduce out-of-pocket expenses of Part D enrollees, which would be a dramatic change from current practice.

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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. The MFP would be established through negotiations between HHS and the manufacturer and would incorporate foreign pricing benchmarks, as further described below. 3, the Elijah E.

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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.

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FDA Law Blog

MAY 19, 2022

By Faraz Siddiqui — Last June, we blogged about a lawsuit brought by the Pharmaceutical Research and Manufacturers of America (PhRMA) challenging CMS’s ill-conceived Accumulator Adjustment Rule (“final rule”), which amended the Medicaid Rebate best price regulation. On Tuesday, May 17, 2022, the D.C.

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FDA Law Blog

NOVEMBER 19, 2024

But shedding regulators in sensitive areas like drug manufacturing—even in the era of influencer-driven medicine—can lead to compromises in safety and efficacy, especially when FDA is already facing a massive inspectional backlog. Over that time the number of vacancies has steadily grown, from 25 in 2021 to 73 in 2023. Kennedy, Jr.,

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FDA Law Blog

MAY 23, 2025

During the first Trump Administration, the 10-for-1 Rule seemed to be more in name only when it came to FDA, whereas this administration seems more intent on its deregulatory approach, so we expect it to have more of an impact on FDA governance this time around. Radical Transparency. Deregulation Efforts.

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FDA Law Blog

MAY 26, 2025

Below, we highlight some of the challenges we would see in the governments attempt to pursue these cases. Second, absent some kind of contractual relationship between a provider and a manufacturer, a provider is generally immune from misbranding if the provider is not also selling a regulated product. Driehaus , 573 U.S. See 21 U.S.C.

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