A product is adulterated if, inter alia, it “has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.” 21 U.S.C. § 351(a)(2)(A). At trial, Kaplan argued that the needle guides were not “held for sale” because he never transferred their ownership to the patients, but merely used them in the treatment of a patient.

If a pharmaceutical company suspects that it might need assistance dealing with a government inquiry or, as a preventive measure, wants to conduct a review of its compliance programs and CGMP processes, our attorneys are well equipped to make assessments and advise as to the best course of action.Authorship Credit: John J. Carney, Lee H. Rosebush, Susrut A. Carpenter, Andrew M. Serrao[1] Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections, U.S. Food & Drug Administration (Mar. 10, 2020), https://www.fda.gov/news-events/press-announcements/coronavirus-disease-2019-covid-19-update-foreign-inspections. [2] Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections, U.S. Food & Drug Administration (Mar. 18, 2020), https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-focuses-safety-regulated-products-while-scaling-back-domestic. [3] 21 U.S.C. § 301 et seq. [4] See 21 U.S.C. § 351. [5] 21 U.S.C. § 351(a)(2)(B). [6] 21 C.F.R. § 211.28(a).

beginning was aimed at marketing Stratus to deliver Kenalog rather than saline.” With respect to design, the evidence reflected that the size of Stratus’s pores had been calibrated to accommodate Kenalog’s specific viscosity – meaning that Stratus did not even work to deliver saline, which is much less viscous and would rapidly seep out. With respect to sales, the government introduced evidence that Stratus “was promoted with a sales strategy devised to get physicians to associate Stratus with Kenalog and consider using it for drug delivery.” For example, sales trainees were not taught or given marketing materials for Stratus describing benefits of use with saline, and instead focused on the off-label uses related to Kenalog.After a jury trial, Acclarent’s former CEO and former vice president of sales were convicted of 10 misdemeanor counts for distributing an adulterated and misbranded device by failing to submit a required premarket notification under 21 U.S.C. §§ 331(a), 333(a)(1), 351(f) and 352(o). The defendants challenged their convictions on appeal, arguing (among other things) that the convictions violated the First and Fifth Amendments.First Amendment does not preclude use of speech as evidence of intended useThe defendants challenged the government’s use of their promotional speech as evidence to support a misbranding violation, arguing that such use effectively criminalizes the speech itself in violation of the First Amendment.In 1993, the Supreme Court ruled in Wisconsin v. Mitchell that the First Amendment does not generally apply to the “evidentiary use of speech to establish the elements of a crime or to prove motive or intent.” However, the Facteau defendants relied on a 2012 Second Circuit ruling (US v. Caronia), where the court held that a misbranding conviction violated the First Amendment. In that case, “the prosecution repeatedly argued that [the defendant] engaged in criminal conduct by promoting and marketing the off-label use of an FDA-approved dr

ntific evaluation,” and with weaknesses in study design are not scientifically sound. Will FDA object to SIUU communications based on such studies that are not scientifically sound?FDA’s recommendation for firm-generated presentations of scientific information is limited to presentations that accompany reprints. Will FDA object to firm-generated presentations of scientific information that are not accompanied by a reprint, or that present scientifically sound and clinically relevant information not contained in the reprint?FootnotesAvailable at: www.fda.gov/regulatory-information/search-fda-guidance-documents/communications-firms-health-care-providers-regarding-scientific-information-unapproved-usesAvailable at: www.fda.gov/regulatory-information/search-fda-guidance-documents/distributing-scientific-and-medical-publications-risk-information-approved-prescription-drugs-and-devicesSee, e.g., Sections 505(a), 515(a), 501(f)(1), and 301(a) and (d) of the FDCA (21 U.S.C.A. 355(a), 360e(a), 351(f)(1) and 331(a) and (d)).See, e.g., FDA’s 2021 Intended Use Final Rule, 86 FR 41383 at 41386-41388.See the FDA Guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers.”See, e.g., Washington Legal Foundation v. Henney, 202 F. 3d 331 (D.C. Cir. 2000); Unites States v. Caronia, 703 F.3d 149 (2d Cir. 2012).

information to detect a life-threatening condition and display time-critical alarms intended to notify an HCP about the need for potential clinical intervention.AGG ObservationsThe Warning Letter distinguishes between MDDS/CDS and medical devices. Companies should review their product labeling, promotion, and other product attributes to evaluate a product’s regulatory status. FDA guidance and our previous Bulletin are useful resources.It appears FDA became aware of the issue during an inspection, and not because of any product promotion.A “misunderstanding” of the law or FDA’s expectations may lead to “some kind of mistake” (another lyric in the aforementioned song), a mistake that can be costly and delay product authorization and sales.AGG Food & Drug co-chair Alan Minsk would like to recognize AGG law clerk Priya Sinha as a co-author of this Bulletin.[1] https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/abiomed-inc-663150-09192023.[2] 21 U.S.C. § 351(f)(1)(B). The device company was also deficient in many quality-related and other issues, but that is beyond the scope of this Bulletin.[3] For more information on FDA’s CDS software guidance, please view a previous AGG Bulletin here.[4] https://www.fda.gov/media/109618/download.[5] https://www.fda.gov/media/88572/download.

a review of each section of the draft guidance.Chemistry, Manufacturing, and ControlsThis section does not provide any policy that is specific or unique to psychedelic drugs but does reference potentially applicable guidance.Two particular topics are discussed, botanicals and current good manufacturing practice (CGMP) requirements for investigational drug products.FDA explains that investigational products that use plant material, algae, or macroscopic fungi may be considered a botanical, and are covered by FDA’s December 2016 “Botanical Drug Development” guidance.Psychedelic compounds that are genetically modified; produced by fermentation of yeast, bacteria, or plant cells; or are highly purified substances derived from naturally occurring sources are not considered botanicals, even though they may be derived from plants or fungi.FDA points out that all investigational drug products are subject to CGMP as required by section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §351(a)(2)(B)).CGMP recommendations for the manufacture of investigational drug products intended for phase I trials are discussed in the July 2008 guidance “CGMP for Phase 1 Investigational Drugs”.CGMP recommendations for investigational drugs intended for phase II and III trials are discussed in the May 2003 guidance “INDs for Phase 2 and 3 Studies; Chemistry, Manufacturing, and Controls Information”.NonclinicalGenerally, FDA’s recommendations for nonclinical testing are found in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline “M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals”, which was adopted by FDA in January 2010.FDA, however, adds additional points regarding nonclinical psychedelic drug development in its guidance.FDA notes that “typical” animal toxicology testing may not be necessary where there is already “extensive human exposure and informatio

Indeed, in a September 2022 FBI Private Industry Notification, the FBI noted that around 53% of connected medical devices and other internet of things (IoT) devices in hospitals had known critical vulnerabilities. These vulnerabilities could allow hackers to direct medical devices to give inaccurate readings, administer drug overdoses, or otherwise endanger patient health.In the past, the U.S. Food & Drug Administration (FDA) has urged manufacturers to take measures to ensure the cybersecurity of their products through non-binding guidance. On December 29, 2022, President Biden signed into law the $1.7 trillion Omnibus Appropriations Act, which provided the FDA with authority to require manufacturers to take cybersecurity protection measures as to medical devices that are brought to market through future pre-market submissions. See H.R. 2617 (117th Congress, 2021-2022), text available here.Section 3305 of the Omnibus Appropriations Act amends the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) to include cybersecurity requirements for “cyber devices,” which are defined to be devices that:“include[] software validated, installed, or authorized by the sponsor [of an application or submission under sections 510(k), 513, 515(c), 515(f), or 520(m)];”“[have] the ability to connect to the internet;” and“contain[] any such technological characteristics validated, installed, or authorized by the sponsor that could be vulnerable to cybersecurity threats.”This definition includes a broad range of devices, from internet-connected devices in hospitals like smart beds, to pain pumps and insulin pumps, and to wearable technology like smart watches.Specifically, under the Act, manufacturers of “cyber devices” must include in premarket submissions “such information as the [FDA] Secretary may require to ensure that such cyber device meets” certain cybersecurity requirements. This includes the following:A plan to monitor, identify, and address, as appropriate, in a reasonable time, p

s to implement specific corrective actions.Additional ConsiderationsThe Warning Letter indicated that a failure to address the noted violations could have serious and varying consequences. Failure to adequately address the notice could result in regulatory action, including seizure, injunction and civil monetary penalties. Non-compliance with the FDCA could impact the award of federal contracts and grant of Certificates to Foreign Governments. FDA’s determination of Quality System violations related to Class III device premarket approval applications could delay the approval of such devices.FOOTNOTES Untitled letter available here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/righteye-llc-643192-12202022. K181771 Indications for Use available here: https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181771.pdf.See 21 U.S.C. § 352(o), 21 U.S.C. § 360(k), 21 CFR 807.81(a)(3)(ii).See 21 U.S.C. § 352(t)(2), 21 U.S.C. § 360i, 21 CFR 830.See 21 U.S.C. § 351(f)(1)(B).See 21 CFR 820.

of the records to FDA, including actions such as removing data columns in a spreadsheet, removing data from the electronic record when providing the record to FDA, exporting data into reports without including all of the data fields (unless otherwise requested by FDA), or locking the electronic worksheet so that the data cannot be searched, sorted, or analyzed by FDA.As in the 2014 Guidance, the Inspection Draft Guidance explains that FDA broadly interprets the terms “delay,” “deny,” “limit,” and “refusal to permit entry or inspection,” and warns that a product may be deemed “adulterated” if a company denies, limits, delays, or refuses entry.Once FDA finalizes the Inspection Draft Guidance, medical device manufacturers will be subject to the principles and recommendations outlined in the guidance. Medical device manufacturers should be prepared to incorporate the principles in the Inspection Draft Guidance into manufacturing site policies and standard operating procedures.FOOTNOTESSee 21 U.S.C. § 351(j).

on (Dec. 2022), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/circumstances-constitute-delaying-denying-limiting-or-refusing-drug-or-device-inspection-december [hereinafter “2022 Draft Guidance”].23See id.; see also FDA, Guidance for Industry, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (Oct. 2014), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/circumstances-constitute-delaying-denying-limiting-or-refusing-drug-inspection [hereinafter “2014 Guidance”].4See FDA, Notice of Availability, Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection; Draft Guidance for Industry, Revision 1, 87 Fed. Reg. 77,125 (Dec. 16, 2022), https://www.federalregister.gov/documents/2022/12/16/2022-27344/circumstances-that-constitute-delaying-denying-limiting-or-refusing-a-drug-or-device-inspection.5See 2022 Draft Guidance at 5.6See id. at 5–7.7See id.8Id. at 4 (quoting 21 U.S.C. § 351(j)).9See id.10See id.; see also 2014 Guidance.11See 2022 Draft Guidance at 4; see also 2014 Guidance.122022 Draft Guidance at 5.13See id. at 7.14See id.15Id.16Id.17Id. at 9.18Id. at 8.19Id20See id. at 9.21See id.22See id. at 10.23Id.24Id25See id.26See id.27See id. at 11.28Id.29See id. at 12.30See id.31Id. at 11.32Id33See id.34See id. at 13.35See id.36See FDA, Notice of Availability, Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection; Draft Guidance for Industry, Revision 1, 87 Fed. Reg. 77,125 (Dec. 16, 2022), https://www.federalregister.gov/documents/2022/12/16/2022-27344/circumstances-that-constitute-delaying-denying-limiting-or-refusing-a-drug-or-device-inspection.