2007, FDA Approval and Marketing - Drug Discovery Digest

FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Most OTC drugs, particularly drugs that have been around for a while, are primarily marketed pursuant to OTC monographs.

FDA Approval

FDA Approval FDA Production Drugs

U.S. FDA Approves PREVNAR 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older

The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

Vaccine

Vaccine FDA Approval FDA Disease

Skinny Label and Induced Infringement: The Saga Continues

FDA Law Blog: Biosimilars

MAY 11, 2023

If an FDA-approved carve-out could support an intent to induce infringement claim, the use of the “section viii pathway would be substantially deterred.” Plainly, the Government brief states “The decision below is incorrect.

Government

Government FDA FDA Approval Doctors

Every Day Counts for PTE: Court Finds FDA’s Reinterpretation of Testing Phase Arbitrary and Capricious

FDA Law Blog: Biosimilars

AUGUST 12, 2024

For animal drugs approved under FDC Act § 512, the “testing phase” begins on the earlier of the effective date of an Investigation New Animal Drug (“INAD”) exemption or the date a major health or environmental effects test on the drug was initiated and ends on the date a NADA is “initially submitted” to FDA under FDC Act § 512(b).

FDA

FDA Regulations FDA Approval Drugs

New Legislation Would Cut Off Access To The Courts And Immunize FDA Actions From Timely Judicial Review

FDA Law Blog: Biosimilars

APRIL 30, 2023

1067, the “ Ensuring Timely Access to Generics Act of 2023 ,” and it would fundamentally transform the playing field for NDA, ANDA, BLA, and aBLA applicants seeking to preserve their rights in the wake of an adverse FDA approval decision. 110-85 (2007), as amended by Section 301 of Pub. That bill is S.

FDA

Analysis Life Sciences Thank You The FDA tried to call the dietary supplement industry’s bluff. It appears to have blinked.

Agency IQ

JUNE 7, 2024

dietary supplement market has grown into a vast industry that has little in common with its DSHEA-era predecessor. But despite a recent attempt by the FDA to wrangle the industry into some degree of control, the agency has not followed through on a threat to go after companies that failed to go through a required premarket review process.

FDA

FDA Science Production FDA Approval

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Agency IQ

JUNE 2, 2023

The FDA first proposed a rule on “Prescription Drug Labeling: Medication Guide Requirements” in 1995 , which was finalized in 1998. However, over the last decade the FDA and other stakeholders have acknowledged that there are opportunities for improvement. After all, companies already have FDA-approved labels.

FDA

FDA FDA Approval Production Regulations

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The FDA maintains a webpage with the full rulemaking history for OTC nasal decongestant drug products.

Science

Science FDA Clinical Trials Clinical Pharmacology

Analysis Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

Agency IQ

MARCH 7, 2024

This follows a contentious April 2023 meeting of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee, at which the committee members raised serious concerns about the methodology of such a study and did not support its utility for a post-marketing requirement (PMR).

FDA

FDA Packaging Science Drugs

Medicare Coverage Analysis Worksheet

Advarra

DECEMBER 14, 2022

Effective as of 2007, Medicare has offered coverage for routine costs in clinical trials. FDA-approved IDE devices may be deemed qualifying under the Medicare Benefit Policy Manual, Chapter 14. The investigational agent in the trial has an FDA-issued investigational new drug (IND) approval and associated six-digit number.

Clinical Trials

Clinical Trials Trials Compliance Pharmacokinetics

Sell or Don’t Sell: Liability May Await Either Way

Drug & Device Law

FEBRUARY 22, 2024

This “keep selling” theory found some traction in two 2007 decisions, Abigail Alliance for Better Access to Developmental Drugs v. 2007) (en banc), and CareToLive v. Ohio 2007), but has generally failed to expand that foothold since. von Eschenbach , 495 F.3d 3d 695 (D.C. von Eschenbach , 525 F. 2d 952 (S.D.

FDA Approval

FDA Approval Clinical Trials Trials FDA

Malarkey ? The Ten Worst Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 21, 2023

We’ve been diligently preparing bottom ten annual lists since 2007, even though it’s distasteful, because if we don’t do it nobody else is likely to, and these abominable decisions deserve to be called out for what they are. Holley also allowed a “pre-approval” warning claim to escape preemption, largely on the same rationale.

FDA Approval

FDA Approval FDA Drugs Production

NPP, DCC, And FDA-Regulated Medical Products

Drug & Device Law

MAY 26, 2023

A hundred years later, we detailed three rounds of litigation over Massachusetts’ serial efforts to ban, or at least substantially limit, the use of FDA-approved pain medications. For instance, Sorsaia primarily involves a challenge to a state trying to prevent in-state use of an FDA-approved drug for its FDA-approved use.

Regulations

Regulations Production FDA FDA Approval

Mifepristone Manufacturer Wins First Round in West Virginia

Drug & Device Law

MAY 19, 2023

The core premise of Bexis’ article is very simple: Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying say “no” and trying to ban that same FDA-approved drug. In GenBioPro, Inc.

FDA Approval

FDA Approval Pharmacy FDA Production

The FDA and Feasible Alternative Designs

Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

FDA

FDA FDA Approval Testimonials Vaccine

Comment K, Presumptions, and Medical Device Design Defects Under Texas Law

Drug & Device Law

FEBRUARY 2, 2023

1974) (applying Texas law), the Fifth Circuit had held: [T]o conclude that the maker of an unavoidably unsafe product did not act unreasonably in placing it on the market is not to relieve him of the responsibility to market it in such a way as to prevent unreasonable danger. 2007 WL 4042757, at *3 (N.D. 15, 2007); McNeil v.

Production

Production FDA Approval Vaccine FDA

Dobbs Would Likely Have Significant Impacts On Drug And Device Companies

Drug & Device Law

JUNE 2, 2022

2012), addressed a challenge to the application of Idaho’s Pain-Capable Unborn Child Protection Act to criminalize the use of an FDA-approved abortifacient medication obtained through an internet prescription and mailed to the plaintiff from out of state. 124 (2007), which would also be knocked out by Dobbs if it sticks.

FDA Approval

FDA Approval Pharmacy FDA Drugs

Split Decision

Drug & Device Law

MARCH 31, 2022

We discussed these concerns – which have since crystallized into what is called either the “municipal cost recovery rule” or the “free public services doctrine” – more detail back in one of the Blog’s early(2007) posts. In other words, the generic manufacturers are not allowed to change the FDA-approved label. E.g , Morris v.

Government

Government Production FDA Approval FDA

Drug Discovery Digest

FDA-Approved Labeling: Is Enough Enough?

U.S. FDA Approves PREVNAR 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older

Trending Sources

Skinny Label and Induced Infringement: The Saga Continues

Every Day Counts for PTE: Court Finds FDA’s Reinterpretation of Testing Phase Arbitrary and Capricious

New Legislation Would Cut Off Access To The Courts And Immunize FDA Actions From Timely Judicial Review

Analysis Life Sciences Thank You The FDA tried to call the dietary supplement industry’s bluff. It appears to have blinked.

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Analysis Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

Medicare Coverage Analysis Worksheet

Sell or Don’t Sell: Liability May Await Either Way

Malarkey ? The Ten Worst Prescription Drug/Medical Device Decisions of 2023

NPP, DCC, And FDA-Regulated Medical Products

Mifepristone Manufacturer Wins First Round in West Virginia

The FDA and Feasible Alternative Designs

Comment K, Presumptions, and Medical Device Design Defects Under Texas Law

Dobbs Would Likely Have Significant Impacts On Drug And Device Companies

Split Decision

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