FDA Law Blog: Biosimilars

APRIL 8, 2024

In 2022, the Government Accountability Office (GAO) reported that FDA needed to improve its foreign inspection program and that report prompted a hearing on Capitol Hill in February of this year where HPM Counsel John Claud offered testimony. Finally, on October 3, 2023, DEA published an increase to the methylphenidate APQ.

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Perficient: Drug Development

JANUARY 23, 2024

I mean, it was Merriam Webster’s word of the year in 2023.) One way is to lean into consumer quotes and testimonials, whether patients or clinical profiles. However, consumers have made it clear that authenticity is exactly what they are after. (I So how can you strike the balance?

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PLOS: DNA Science

OCTOBER 19, 2023

But it took until this September 27, 2023, for FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee to finally vote. The amazing testimonials we have seen online do not align with the data that BrainStorm has shared with us or has been published in peer-reviewed publications.

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The latest update, announced this week, is known as the Spring 2023 Unified Agenda.

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Agency IQ

MAY 28, 2024

The new draft document comes as FDA leadership has been flagging concerns about misinformation, including in public testimony and reports. For example, recent guidance from the National Institute of Standards and Technology (NIST) offered insights into how Generative AI could contribute to health care misinformation.

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Agency IQ

MARCH 1, 2024

In September 2023’s version of the FY 2024 contingency plan , the agency stated that 81% of staff would be retained: “15,602 (81%) of FDA staff will be retained including 12,300 (64%) who are exempt (their activities or position are already funded or otherwise exempted) and 3,302 (17%) who are excepted.” What happens to inspections?

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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PLOS: DNA Science

APRIL 4, 2024

” The Patent Trail Rather than relying on social media, company websites, and testimonials, I consulted the Patent and Trademark database to reconstruct the story of invention. A highly-tauted quality of Lume is that the effect lasts 72 hours, although a class action lawsuit filed May 2023 challenges that claim, key to the advertising.

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Agency IQ

OCTOBER 20, 2023

OCT 11, 2023 7:05 PM CDT What are PFAS? The EPA updated and widened the definition of a PFAS in the final TSCA recordkeeping and reporting rule for PFAS published on October 11, 2023. On June 28, 2023, the EPA published a TSCA framework for how it planned to address new PFAS and new uses of PFAS. BY PATRICIA ISCARO, ESQ. |

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FDA Law Blog: Biosimilars

MARCH 14, 2023

Merrick Garland, Testimony Before the Senate Judiciary Committee, Mar. 1, 2023 ( 02:38:46 ). AG Garland concluded that he anticipates DOJ’s cannabis policy will be consistent with what he said during his confirmation in that “it will be very close” to the Cole Memorandum.

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Agency IQ

JULY 28, 2023

Everything the FDA is planning to do in Q3 2023 The third quarter of the 2023 calendar year is shaping up to be one of the busiest periods of regulatory policymaking at the FDA in at least the last decade. Notably, one aspect of its transition plan will come into effect on August 9, 2023.

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Agency IQ

JULY 13, 2023

BY LAURA DIANGELO, MPH JUL 12, 2023 7:14 PM CDT Quick background: the Pandemic and All-Hazards Preparedness Act The Pandemic and All-Hazards Preparedness Act (PAHPA) was originally passed in 2006. PAHPA must be reauthorized by the end of federal fiscal year 2023, or by September 30, 2023. Pallone (D-NJ)

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Drug & Device Law

DECEMBER 21, 2023

Speaking of cold and darkness, it is now time for us to look back upon the results of drug and medical device litigation during 2023 and to select the ten worst decisions of the year. 122 (2023) ( here ). 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. FDA , 78 F.4th

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Drug & Device Law

JUNE 15, 2023

Ladapo , 2023 WL 3833848 (N.D. 2023), appeared in our daily search results because it briefly addresses off-label use of prescription drugs. 2023 WL 3833848, at *3. Doe , 2023 WL 3833848, at *2. 2023 WL 3833848, at *2. 2023 WL 3833848, at *2. 2023 WL 3833848, at *2. 2023 WL 3833848, at *7.

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Drug & Device Law

JUNE 1, 2023

We think that they can, and for a state (like Pennsylvania and a number of others) that still follows the “ Frye ” standard looking to the “general acceptance” of expert testimony as the touchstone to admissibility, a Rule 702 state-law equivalent might look something like this: Rule 702. E.g. , Walsh v. BASF Corp. , 3d 446, 461 (Pa.

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Drug & Device Law

JULY 24, 2023

3d , 2023 WL 4191651 (C.D. PATDC82 II , 2023 WL 4191651, at *3. 2023 WL 4191651, at *8. PATDC82 II , 2023 WL 4191651, at *10. This time-tested type of evidence is mostly absent from the analysis in PATDC82 II – as in Neurontin , the only actual prescriber testimony belied plaintiffs’ position.

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Drug & Device Law

FEBRUARY 11, 2024

3d , 2023 WL 2825871 (N.D. April 7, 2023) (“ AHM I ”). 2023) (“ AHM II ”). See AHM I , 2023 WL 2825871, at *4 n.9 19, 2021) (admitting and excluding Studnicki testimony); Whole Woman’s Health Alliance v. See Alliance for Hippocratic Medicine v. See Alliance for Hippocratic Medicine v. FDA , 78 F.4th Studnicki J.,

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Drug & Device Law

DECEMBER 28, 2022

As we prepare to greet 2023, we find ourselves assuming the Janus-ian posture of simultaneously looking backward and forward. Even if expert testimony on general causation were not required, the plaintiffs did not manage to produce evidence from which a jury could infer that the drug was capable of causing heart failure.

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Drug & Device Law

JANUARY 15, 2024

2021), aff’d by an equally divided court , 2023 WL 8859656 (Pa. 22, 2023) (“ Sullivan I ”), another decision not involving prescription medical products. 2023 WL 8859656, at *9 (Pa. 22, 2023) (Opinion Announcing the Judgment of the Court (“OAJC”)). OAJC, 2023 WL 8859656, at *11. Werner Co. , 3d 730 (Pa. Sullivan v.

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Drug & Device Law

DECEMBER 28, 2023

3d _-, 2023 WL 8711617 (S.D.N.Y. 18, 2023), is a worthy heir to the history above. 2023 WL 8711617, *2. In a paraphrase of the testimony of a difficult opposing epidemiology expert who passed away recently, “you have to say what you will do and then do what you say.” Litig. , — F.

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Drug & Device Law

DECEMBER 20, 2023

Facteau , 2023 WL 8641918 (1st Cir. Despite the chorus of criticism of recent Congressional testimony by a trio of tone-deaf college presidents, there really is a valid, if sometimes difficult, distinction between speech and conduct.) Such is the case with United States v.

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Drug & Device Law

MAY 30, 2023

United States VA , 2023 U.S. May 16, 2023). The VA’s regulations provide that “VA personnel may not provide testimony or produce VA records in legal proceedings with the prior written approval of the responsible VA official designated.” The case is Schroeder v. LEXIS 85835 (D. Schroeder , at *4.

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Drug & Device Law

OCTOBER 11, 2023

19 2023). See LCJ, “ FRCP Amendments Are Needed To Guide Courts and Litigants in Proactively Managing Their Shared Obligations To Protect Privacy Rights and Avoid Attendant Cyber Security Risks ” (LCJ Sept. We think that’s an important initiative that our audience should know about, and consider. The court in Bell v. 3d 520 (M.D.N.C.

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Drug & Device Law

FEBRUARY 14, 2023

Dean Health Plan , 2023 WL 1820994 (E.D. Defendant, of course, argued a lack of causation based on plaintiff’s surgeon lack of reliance on or even reading of any of defendant’s warnings or labeling and his testimony that he performed the surgery based on his own experience and training. When is a warning not a warning?

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Drug & Device Law

MARCH 16, 2023

In two of these cases, our client won summary judgment at the trial court level and an appellate court ended up creating a new cause of action to accommodate the plaintiff’s theory (and lack of helpful testimony from the prescribing physician). 1:22-cv-00141-MR, 2023 WL 2386776 (W.D.N.C. 2023 WL 2386776, *3. In Beaver v.

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Drug & Device Law

MARCH 23, 2023

22-1737, 2023 WL 2446703 (4th Cir. 10, 2023). Plaintiff also argued that the trial court should have allowed her to offer expert causation testimony from the explanting physician, thus raising an issue of material fact to defeat summary judgment. In an unpublished decision, the Fourth Circuit affirmed. Ethicon, Inc. ,

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Drug & Device Law

FEBRUARY 20, 2023

2023 WL 1192538 (Mag. 27, 2023), which we discussed here , addressed at length the plaintiff’s attempt to rely on “alternatives” that “existed,” but “were not yet cleared by the FDA for the purpose of treating” the plaintiff’s condition. Therefore, Davis excluded as “not relevant” expert testimony about non-FDA-approved alternatives.

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Drug & Device Law

OCTOBER 18, 2023

In our recent ediscovery for defendants update , we highlighted two of the twenty-eight cases we included as the most important: In re Tasigna (Nilotinib) Products Liability Litigation , 2023 WL 6064308 (Mag. 18, 2023), and Davis v. March 16, 2023). 2023 WL 6064308, at *1. Disability Rights New Jersey , 291 A.3d

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Drug & Device Law

OCTOBER 4, 2023

25, 2023), is a not very good decision. Not citing any case where such a distinction had been recognized, the Burton court held the difference between SJS and TEN, and the significance of such difference, to be questions of fact “that will require medical expert testimony to resolve.” We learned a lot. We have warm feelings for C.D.

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Drug & Device Law

JUNE 20, 2023

2023 WL 4034314 (U.S. June 16, 2023), affirming a Third Circuit decision we discussed here. Polansky , 2023 WL 4034314, at *4 (citations and quotation marks omitted). Polansky , 2023 WL 4034314, at *6. Polansky , 2023 WL 4034314, at *7 (statutory citations omitted). Polansky , 2023 WL 4034314, at *9.

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Drug & Device Law

SEPTEMBER 12, 2023

Opting instead for expert testimony based on a consumer’s perspective is risky and likely problematic. If a court tells you your only non-preempted claim is one based on a theory that your labeling does not comply with the Federal Food, Drug & Cosmetic Act (“FDCA”), it’s probably a good idea for your expert so opine.

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Drug & Device Law

OCTOBER 31, 2023

Howmedica Osteonics Corporation, 2023 WL 6850144 (D. 17, 2023) told plaintiff when it dismissed his case. Clinical experience can be a basis for reliable expert testimony, but only where the clinician has “extensive experience” with the issue on which he is opining. As the court in Hobus v.

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Drug & Device Law

SEPTEMBER 25, 2023

Assuming the expert testimony doesn’t change, the defendant essentially gets a do-over. 3d , 2023 WL 5541638 (D. July 10, 2023). Not surprisingly the once and future exclusion of the plaintiffs’ expert testimony loomed large in this ginned-up dispute. 2023 WL 5541638, at *2 (quoting 28 U.S.C. See Gareis , supra.

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Drug & Device Law

JUNE 14, 2023

Sometimes expert testimony bolsters the warnings story for one or both sides, but not always. 2023 WL 3589654 (Ariz. May 23, 2023). The defendant has the option of offering “responsive expert testimony that physicians are free to ignore such a directive.” And therein, in a strange way, lies our interest in Francisco v.

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Drug & Device Law

DECEMBER 12, 2023

In re: Zostavax Products Liability Litigation , 2023 WL 8258533, *1 (E.D. Ten cases alleging miscellaneous injuries were selected for trial by plaintiffs and defendants, and all were dismissed either because plaintiff conceded they could not get expert testimony or because the court excluded what expert evidence was offered.

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Drug & Device Law

JUNE 6, 2023

2023 WL 1192538 (Mag. 27, 2023) that granted summary judgment to defendant on all claims – failure to warn and design defect – for a lack of causation. 2023 WL 3681693 (Mag. So, at most plaintiff had her experts’ testimony that defendant did not do enough testing. Ethicon Inc., That led to today’s decision – Baksic v.

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Drug & Device Law

JANUARY 5, 2024

2023 WL 8717570 (W.D. 18, 2023). 2023 WL 8717570, *3. Plaintiffs had no evidence to rebut the treater’s clear testimony. The best group of legal wonks there is. Today we discuss the Western District of Washington’s recent summary judgment order in Dearinger v. Eli Lilly & Co.,

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