FDA Law Blog

JUNE 3, 2021

Schlanger — While federal efforts to address prescription drug prices are debated, states have continued to pursue their own measures that require drug manufacturers and other entities in the drug supply chain to disclose information about pricing. The 2019 law did not include any penalties for noncompliance with these reporting requirements.

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FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

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FDA Law Blog

SEPTEMBER 7, 2022

Number of Manufacturing Sites and Registered Products. The report states that for fiscal year 2021, there were 4,451 CDER drug manufacturing sites, which is a 3% increase over fiscal year 2018, the only comparison year provided. For fiscal year 2021, CDER oversaw 12,428 ANDAs, 3,537 NDAs and 315 BLAs. Import Alerts and Recalls.

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FDA Law Blog

JUNE 28, 2021

Under current Minnesota law enacted in May 2019, manufacturers that sell, deliver, or distribute into or within Minnesota 2 million or more units of an opiate are required to pay an annual product registration fee of $250,000.

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FDA Law Blog

SEPTEMBER 11, 2023

More recently, in 2019, FDA announced a push for predicate modernization ( link ) following a 2018 plan to modernize the 510(k) program by eliminating use of old predicates, sunsetting older predicates, and establishing the Safety and Performance Based Pathway ( link ).

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FDA Law Blog

SEPTEMBER 29, 2021

Department of Health and Human Services (“HHS”), which reported that discounted purchases totaled $38 billion in 2020, a 27% increase compared to 2019. Manufacturers may choose not to participate in this program, but the federal government will not reimburse for their outpatient drugs under Medicaid or Medicare Part B if they do not.

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FDA Law Blog

NOVEMBER 6, 2022

Pfizer manufactures tafamidis (sold under brand names Vyndaqel and Vyndamax), a breakthrough treatment for a rare, progressive heart condition called transthyretin amyloid cardiomyopathy (ATTR-CM). In June 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. Background.

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FDA Law Blog

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).

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FDA Law Blog

FEBRUARY 5, 2023

Last week, a panel of three judges at the Third Circuit who reviewed these three cases decided in favor of the drug manufacturers. First, the statute requires manufacturers to offer 340B prices to covered entities but is silent about delivery. The court decided that it did not, and gave three reasons for its decision.

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FDA Law Blog

JUNE 15, 2022

billion annually, and continued the same reimbursement cuts for 2019. In 2019, we blogged that the District Court found for the plaintiffs, holding that CMS did not have the statutory authority to make such a change without first conducting a hospital acquisition cost survey data. CMS estimated a savings of $1.6 See 85 Fed.

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FDA Law Blog

OCTOBER 14, 2021

FDA issued the same type of warning regarding RAS devices and mastectomy back in February 2019 suggesting that FDA believes the problem has persisted. Given these onerous requirements, it is not a surprise that RAS device manufacturers have not sought clearance for RAS devices for oncology procedures.

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FDA Law Blog

OCTOBER 20, 2021

As we have previously discussed , under the PMTA pathway, manufacturers must demonstrate that, among other things, marketing of the new tobacco product would be appropriate for the protection of the public health. In a press release announcing the orders, Mitch Zeller, J.D.,

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FDA Law Blog

OCTOBER 2, 2024

FDA, Guidance for Industry, The Special 510(k) Program (2019). While the description of the content that should be included in a PCCP is generally helpful, the Draft Guidance leaves much uncertainty—and uneasiness—about the types of changes FDA will ultimately allow manufacturers to make via the PCCP process.

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FDA Law Blog

APRIL 19, 2021

The Court decision limiting FDA’s discretion provides regulatory certainty for device manufacturers, as the claimed discretion, if recognized by the Court, would have meant that any medical device potentially could be classified and regulated as a drug. District Court, which sided with Genus in December 2019.

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FDA Law Blog

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. FDA gives no rationale for interpreting the apparently broad statutory term “medical information” in such a restrictive manner.

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Health One Family Medicine

APRIL 30, 2021

As with parabens, manufacturers add them to reduce the risk of bacterial contamination. Contaminated Talc In 2019, the FDA advised consumers to avoid using certain cosmetic products because they tested positive for asbestos. This means they can upset your hormones and alter your growth, development, and reproduction.

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FDA Law Blog

FEBRUARY 28, 2022

The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies.

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FDA Law Blog

SEPTEMBER 15, 2022

FDA indicates that this guidance is intended to help manufacturers ensure consistent content and format of the statement of identity and strength for all nonprescription drug products, which then will allow consumers to compare products. For both draft guidances, it is unclear what induced FDA to publish these draft guidances now.

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FDA Law Blog

OCTOBER 1, 2024

Specifically, Vanda alleges that FDA communications to certain generic competitors regarding dissolution rates, impurities, and micronization revealed Vanda’s confidential manufacturing information and caused economic injury to the company. VANDA PHARMACEUTICALS, INC. 1:2022cv00938 (D.D.C.) Preliminary Injunction) Table 2.

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FDA Law Blog

OCTOBER 14, 2024

Court Opinion One of Defendant’s primary arguments was that its SVF treatments constituted the practice of medicine, not the manufacture and administration of a “drug” and were, therefore, not subject to FDA regulation. 588, 566 (2019)). Robbins , 519 U.S. 452 (1997); see also Kisor v. Wilkie , 588 U.S.

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FDA Law Blog

MAY 2, 2022

They are the most stringently regulated substances of abuse and it is unlawful to manufacture and distribute them. 15 and 16, 2019). 21 U.S.C. § It is important to understand the lead up to Garland’s stance. Confirmation Hearing on the Nomination of Hon. William Pelham Barr to Be Attorney General of the United States, S.

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FDA Law Blog

DECEMBER 21, 2021

In other words, the California law assumes that every potential Paragraph IV patent settlement is anticompetitive, and the pharmaceutical manufacturers must show that the settlement is not anticompetitive to avoid upwards of $20 million in fines.

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FDA Law Blog

APRIL 11, 2022

As background, Medtronic manufactures the MiniMed 600 series insulin infusion pumps. During an inspection, FDA learned that Medtronic had opened a CAPA to address complaints of damaged retainer rings in these pumps (more than 74,000 between June 2016 and November 2019, with more than 57,000 reported to FDA as MDRs).

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The Clinical Problem Solvers

NOVEMBER 6, 2023

Between the years 2019 and 2021, Harrison served as Associate Editor—and later as Managing Editor—of Wear Your Voice Magazine. Harrison currently serves as Editor-at-Large at Scalawag Magazine, is a co-host of the podcast “Unsolicited: Fatties Talk Back,” and one third of the video podcast “In The Middle.” Williams-Forson and Da’Shaun L.

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FDA Law Blog

SEPTEMBER 30, 2024

CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. Remarkably, manufacturers may not dispute a CMS notification.

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Physician's Weekly

JUNE 19, 2025

Bob’s journey here begins in 2019 — the first day of high school for his daughter, Mary. Claire: All of that, but the celebrity factor isn’t really what makes Cost Plus different: The company buys meds direct from manufacturers, and adds 15 percent to their wholesale cost. Dan: Another addition: Manufacturer coupons.

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Common Sense Family Doctor

FEBRUARY 15, 2025

On Sensible Medicine, Dr. Edward Livingston pointed out that the manufacturer, AbbVie, spent $580 million on DTCA for this drug in 2023, or $290 for each of the 2 million potential patients in the United States. The annual price of risankizumab is $288,000, so this is still a huge bargain for the company given the potential returns.

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FDA Law Blog

NOVEMBER 22, 2022

Reported illnesses began just three days before Thanksgiving in 2017, but due to the unknown source of the turkey at the center of the outbreak, the Centers for Disease Control and Prevention (CDC) did not conclude the outbreak investigation until April 2019. Two days before Thanksgiving the following year, the CDC warned U.S.

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FDA Law Blog

JUNE 2, 2023

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average manufacturer price (AMP), best price, and nominal prices.

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FDA Law Blog

DECEMBER 21, 2021

In other words, the California law assumes that every potential Paragraph IV patent settlement is anticompetitive, and the pharmaceutical manufacturers must show that the settlement is not anticompetitive to avoid upwards of $20 million in fines.

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FDA Law Blog

AUGUST 21, 2023

Specifically, the Court explained, because “[t]he Pregnancy Warning Regulation simply does not speak to whether a further warning related to a drug’s use during pregnancy can be added to the general Pregnancy Warning on a drug label, whether added by the FDA or added by a manufacturer,” the ”regulation does not, therefore, preempt state law.”

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FDA Law Blog

FEBRUARY 4, 2025

The authors suggested that the developers of such therapies would receive a priority review voucher that they can sell to manufacturers of blockbuster drugs.

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GeriPal

MARCH 2, 2023

AFP 2019 Gabapentin for chronic neuropathic pain in adults. And for that reason, there was actually an enormous lawsuit, and the manufacturer was fined, now I think 20 years ago, in the millions and millions of dollars for off-label prescribing. Cochrane Database of Systematic Reviews Review.

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GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution.

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FDA Law Blog

JANUARY 11, 2022

The Federal Circuit twice reversed the District Court decision at issue in GSK v. Amarin listed Vascepa in the Orange Book with multiple patents, including several method-of-use patents covering only the CV indication.

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FDA Law Blog

JANUARY 11, 2022

The Federal Circuit twice reversed the District Court decision at issue in GSK v. Amarin listed Vascepa in the Orange Book with multiple patents, including several method-of-use patents covering only the CV indication.

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FDA Law Blog

JUNE 10, 2025

Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Manufacture of Controlled Substances and Listed Chemicals, 90 Fed. We think that the agency will revise and update the list more frequently as clandestine manufacturing trends require. 21 U.S.C. § 21 U.S.C. § 842(a)(11). 23,711 (June 4, 2025).

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