FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. Part 1: Multiple PTEs Under the PTE statute at 35 U.S.C. § To that end, 35 U.S.C. § 156(c)(4)

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Agency IQ

JUNE 2, 2023

The FDA recently concluded its work on a proposed rule focused on PMI. The regulator sent the rule to the White House’s Office of Information and Regulatory Affairs (OIRA) on October 4, 2022. The content of the PMI : The regulation describes, in broad terms, what must be included in the PMI.

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Drug & Device Law

DECEMBER 21, 2023

FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. That’s significant because the labels for over 500 drugs already have such information, under a voluntary FDA program. Remember Riegel ( 2008+1 )? 4th 210 (5th Cir. Gilead Sciences, Inc.

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Drug & Device Law

MARCH 25, 2022

Even before the anti-osteoporosis drug Fosamax was FDA approved, its manufacturer was aware of a biologically plausible mechanism for that class of drug (“bisphosphonates”) to cause low-energy – later renamed “atypical” ? The manufacturer informed the FDA, but no evidence then established that risk as anything more than hypothetical.

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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. See this post on one of our decisions from 2008.) Hiedeman, 694 F.3d

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Drug & Device Law

JANUARY 30, 2023

440 (2008) Buckman was not cited at all in the Merck Sharp & Dohme Corp. Plaintiffs Legal Committee , 531 U.S. Kent , 552 U.S. Albrecht , 139 S. 2019), or Mutual Pharmaceutical Co. Bartlett , 570 U.S. 472 (2013), implied preemption decisions, cited only by the dissent in Wyeth v. . Jones , 225 U.S. Davidowitz , 312 U.S. Myrick , 514 U.S.

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Drug & Device Law

DECEMBER 30, 2022

When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications. An unfortunate fiction developed post- Buckman —particularly after Riegel v.

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Drug & Device Law

SEPTEMBER 18, 2023

The ASR program was initially open to regulated manufacturers of twelve device categories; Intravascular (I.V.) FDA, CDER, “Guidance for Industry − Medical Device Reporting − Alternative Summary Reporting (ASR) Program, 2000 WL 34503093, at *1 (Oct. 312 (2008). an exemption from the individual event reporting requirements.”

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Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. Lederle Laboratories , 2008 WL 972657 (W. In Bruesewitz v. Wyeth LLC , 562 U.S. at 237-38. 2d at 401.

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Drug & Device Law

JULY 18, 2023

As evidenced by our PMA Preemption Score Card , on which today’s case became the 651 st entry, defendant manufacturers of FDA-approved Class III medical devices generally do pretty well with preemption motions. 312 (2008). Since that would encroach on the FDA’s regulatory authority, this claim is also expressly preempted.

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Drug & Device Law

MAY 4, 2023

2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. FDA approved the drug with its particular formulation and the manufacturer could not have changed the formulation on its own. As detailed here , the decision in Yates v. 3d 281 (6th Cir.

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Drug & Device Law

SEPTEMBER 22, 2023

Constitution’s Supremacy Clause, it strikes a balance between state and federal power on issues of public health and safety, and raises questions about whether our country’s approach to regulation and litigation makes sense for pharmaceuticals and medical devices (spoiler alert: it doesn’t). 312 (2008), and considering 21 U.S.C.

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Drug & Device Law

JUNE 28, 2022

June 24, 2022), we fully expect attempts by such states to ban FDA-approved prescription drugs that can be used to bring about abortions by chemical means. On occasion, states have attempted to prohibit sale and/or use of non-abortion-related FDA-approved products, but with one exception, these efforts have not resulted in litigation.

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