All Matters FDA March 31 Virtual

Save the Date March 31, 2022

1pm-5pm Virtual

Find out the latest about COVID-19 from FDA’s Biologics Center Director Dr. Marks and other notable speakers. Other topics include criminal and civil enforcement, mandatory food recalls, vaping, e-cigarettes, unsafe pet products in the marketplace.  Invited Speakers/Designees to date include:

Brook Duer, JD, Pennsylvania State Univ., Center for Agriculture Law

Michael Helbing, JD, Office of Chief Counsel, U.S. Food and Drug Administration

Peter Marks, MD, PhD, Director, Center for Biologics, U.S. Food and Drug Administration

Christopher Mondics, Moderator

Matthew Noonan and Lillian Hsu, FDA Preventive Controls (PC) experts in CFSAN Office of Compliance, U.S. Food and Drug Administration  

Jessica Sleater, Esq. Veterinary Medicine, Pet Products

Roseann B. Termini, Esq., Food and Drug Law Cutting Edge Issues including Vaping

Julia C.Tierney, JD, Chief of Staff, U.S. Food and Drug Administration


Further Info. Roseann Termini: rbtermini@widener.edu

COVID-19 Treatment— FDA Issued Emergency Use Authorization to Pfizer

FDA granted the first oral treatment on Dec. 22. The FDA authorized Pfizer’s, Inc.’s (Pfizer) request that the Food and Drug Administration (FDA or Agency) issue an Emergency Use Authorization (EUA) for PAXLOVID (nirmatrelvir co-packaged with ritonavir) for treatment of mild-to-moderate COVID-19 in some adults and pediatric patients under the official Section 564 of the Federal Food, Drug, and Cosmetic Act codified in 21 U.S.C. §360bbb-3).

Here is the direct link to the EUA letter. https://www.fda.gov/media/155049/download

In the press release, Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research remarked:

“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.”

Direct Link to press release: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19

Overview of Expanded Access (EA) Program and EA eRequest Site 

Here is the link to the one hour webinar presented by FDA Dec. 14, 2021 1- 2pm EST

https://www.fda.gov/about-fda/fda-pharmacy-student-experiential-program/fda-drug-topics-overview-expanded-access-ea-program-and-ea-erequest-site-december-14-2021

REGISTRATION LINK:  https://collaboration.fda.gov/ddi121421/event/registration.html

More Details About Webinar from FDA

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians. Interact with FDA staff from a variety of divisions and learn more about the FDA and drug regulation!

On Tuesday, December 14, 2021, at 1:00PM ET, CDER’s Office of Communication, Division of Drug Information (DDI) will host a webinar titled: FDA Drug Topics: Overview of Expanded Access (EA) Program and EA eRequest Site. Expanded Access (EA) is use of an investigational drug or biologic to treat a patient with a serious disease or condition who does not have comparable or satisfactory alternative therapies. This webinar will provide an overview of FDA’s EA Program and introduce participants to resources like the EA eRequest site hosted by the Reagan-Udall Foundation for the FDA. The EA eRequest site enables physicians to prepare and sign EA requests and submit those requests securely to FDA.

Register Here: https://collaboration.fda.gov/ddi121421/event/registration.html

Activity Outline and Continuing Education Information: Overview of Expanded Access (EA) Program and EA eRequest Site (PDF – 158KB)

Ohio Opioid Verdict Brings Focus To Role Of Pharmacists

Duty to Warn

By Roseann Termini ·Law360® (December 1, 2021, 5:03 PM EST)  

The recent U.S. District Court for the Northern District of Ohio jury verdict in the combined cases In re: National Prescription Opiate Litigation, County of Lake v. Purdue Pharma LP and County of Trumbull v. Purdue Pharma LP, finding pharmacies liable for contributing to the opioid epidemic, has far-reaching consequences.[1]

Undoubtedly, the three chain pharmacies found liable for public nuisance, CVS Health Corp., Walmart Inc. and Walgreens Co., will appeal; however, that does not diminish the effect of the decision on pharmacists’ duty to warn or refuse to fill a prescription.

The initial inquiry involves the role of the various actors in this epidemic. Is it simply the physicians as the learned intermediaries, the pharmaceutical manufacturers who heavily promote the product, the drug distributors and the government? Or are there other players who play a role, such as the pharmacist?

Previously pharmacists were rarely mentioned as contributors to the opioid epidemic. Yet, pharmacists, as well as others mentioned above, play a significant role. A practitioner providing legal counsel to a pharmacist has a duty to advise in this regard.

The jury in the Ohio verdict recognized that the opioid crisis did not simply occur overnight and that pharmacists played a critical role in this epidemic.

The opioid epidemic is such that the pharmacist, as a professional, could red-flag or refuse to fill an opioid drug prescription for the patient. There is a duty of the professional pharmacist to warn — and the jury in the Ohio cases understood that duty. Practitioners also need to advise pharmacists of this critical duty.

Years ago, most courts found pharmacists owed no duty to warn. The consensus among the majority of courts centered on the physician as the conduit for conveying information to the patient and assessing the risks involved with the adverse effects of a prescription drug. The physician, as the learned intermediary between the manufacturer and the patient, was deemed the proper medical professional to warn a patient of possible risks associated with drug consumption.

Traditionally, under the learned intermediary doctrine, the physician had the sole responsibility to monitor and counsel the prescription drug consumption of a patient. Thus, the sole obligation of the pharmacist centered on the accurate dispensing of pharmaceuticals.

Yet, health care today is not the Norman Rockwell picture of yesteryear.

Today, the role of the pharmacist in the health care system has taken on a greater significance. Recent changes in pharmacist education, sophisticated tracking technology, direct-to-consumer advertising and the competitive nature of the pharmaceutical market have altered the scope of liability on the part of pharmacists.

The view has evolved into greater recognition of pharmacists as proactive professionals in the health care field. Advances in technology also expanded the role and capabilities of pharmacists. Computer systems that maintain patient profiles and warn of drug interactions are now commonly utilized within the pharmaceutical market, especially at huge chain drugstores such as Walgreens, Walmart and CVS Health.

The Ohio decision brings into focus when a pharmacist owes a duty to warn.

When Pharmacists Owe a Duty to Warn

The opioid epidemic is one where pharmacists’ actions should be scrutinized.

The primary legal decision supporting pharmacist liability is Hooks SuperX Inc. v. McLaughlin.[2] In that 1994 decision, the Supreme Court of Indiana determined a pharmacist had a duty to refuse to refill prescriptions at an unreasonably faster rate than prescribed, pending direct and explicit directions from the prescribing physician.

Furthermore, the court found that the duty of the pharmacist to provide a standard of care includes the duty to refuse to refill a prescription.

In Hooks, the customer was injured while working and his physician prescribed medication to relieve the pain. The customer became addicted to this medication and was treated for this addiction on numerous occasions. The customer had his prescriptions filled at the same pharmacy for a period of about one-and-a-half years. Although all the prescriptions were valid, the customer had them refilled at a rate considerably faster than the rate prescribed.

The Supreme Court of Indiana considered three factors in concluding a duty exists between a pharmacist and a customer: the relationship between the parties, the foreseeability of harm and public policy.

First, to determine whether there was a relationship between a pharmacist and customer sufficient to constitute a duty, the court focused on what constitutes a relationship. The court found the relationship between a pharmacist and a customer was based on contract principles and was independent of the physician-patient relationship. The Hooks court found the existence of privity of contract between the parties and the expertise of the pharmacist sufficiently close to justify the imposition of a duty.

Second, the Hooks court examined the foreseeability of the harm. The court held it is reasonably foreseeable that consumption of large quantities of addictive substances can give rise to an addiction and that addiction carries foreseeable consequences. Therefore, for the purpose of determining the existence of a duty, the court was satisfied that the addiction was foreseeable from the series of events that occurred.

Third, the Hooks court analyzed the three public policy considerations present: preventing intentional and unintentional drug abuse, not jeopardizing the physician-patient relationship and avoiding unnecessary health costs. The court determined that the public policy of Indiana requires the imposition of a duty on the pharmacist.

The court examined the Indiana Pharmacy Code, which provides immunity for a pharmacist who refuses to fill a prescription: “The pharmacist is immune from criminal prosecution or civil liability if he, in good faith, refuses to honor a prescription because, in his professional judgment, the honoring of the prescription would … [a]id or abet an addiction of habit.”

Although the statute does not create a duty on the part of the pharmacist, the Hooks court found the statute demonstrates the state’s significant interest in preventing drug addiction. The Hooks court concluded that establishing this duty for pharmacists would not interfere with the physician-patient relationship.

The principles enunciated in Hooks similarly apply to the current opioid litigation. All the factors detailed in Hooks — relationship between the parties, foreseeability of harm and public policy for determining the imposition of a duty — indicate this obligation should be utilized in the opioid crisis.

Understandably, what is required in each case is a question of fact depending upon the circumstances of each case. These elements relied on by the Hooks court — relationship, foreseeability and public policy — all evidenced the recognition of an independent duty on the part of the pharmacist separate from that of the physician. Those elements undoubtedly are relevant to the opioid epidemic.

Final Commentary for Practitioners

The crisis our nation struggles with today did not materialize overnight. The opioid epidemic is complex and there is no simple, quick-fix solution. Decades of questionable practices in the pharmaceutical and medical communities, coupled with government decisions, barriers to treatment, and lack of public and medical awareness around addiction created this enormous problem.

The pharmacist plays a serious role in the crisis. The pharmacist is the final point of patient contact. The pharmacist most certainly can refuse to fill the prescription and/or contact the prescribing physician.

Regarding many of the opioid lawsuits, including the recent Ohio decision, there should have been a red-flag system in place. Alternatively, if there was a system to flag these prescriptions, it was disregarded. There is no excuse for filling the abnormally high volume of prescriptions.

Finally, today the pharmacist is more than a pill counter and is obligated to uphold the tenets of the Oath of a Pharmacist, which, in part, is as follows:

I promise to devote myself to a lifetime of service to others through the profession of pharmacy. In fulfilling this vow:

  • I will consider the welfare of humanity and relief of suffering my primary concerns.
  • I will apply my knowledge, experience, and skills to the best of my ability to assure optimal outcomes for my patients.
  • I will hold myself and my colleagues to the highest principles of our profession’s moral, ethical and legal conduct.

The recent Ohio verdict demonstrates that the days when the sole duty of a pharmacist consisted of accurately filling and dispensing prescription drugs are no longer — and it is incumbent that pharmacists be aware of this.


Roseann B. Termini is teaches at Widener University’s Delaware Law School. She is the author of “Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Food, Dietary Supplements, Personal Care, Veterinary and Tobacco Products.”

The opinions expressed are those of the author(s) and do not necessarily reflect the views of the organization, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.

[1] In re: National Prescription Opiate Litigation, case number 1:17-md-02804, County of Lake v. Purdue Pharma LP et al., case number 1:18-op-45032, and County of Trumbull v. Purdue Pharma LP et al., case number 1:18-op-45079, in the U.S. District Court for the Northern District of Ohio.

[2] Hooks SuperX v. McLaughlin , 642 N.E.2d 514 (Ind. 1994). 

For a reprint of this article, please contact reprints@law360.com.

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COVID-19 Booster Update

Booster

FDA authorized the use of a heterologous or mix and match booster. This means that Pfizer-BioNTech COVID-19 vaccine recipients falling into one of the authorized categories for boosters may receive  the Moderna COVID-19 Vaccine which is a half dose, Pfizer-BioNTech COVID-19 Vaccine or Janssen COVID-19 Vaccine. The booster should be administed at least six months after completing the primary vaccination.https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine

FDA Approves New Treatment for Alzheimer’s Disease

In an interesting decision FDA decided on June 7 to approve a controversial new treatment for Alzheimer’s Disease, Aducanumab (trade name Aduhelm)

What is Aduhelm?

Aduhelm is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease.

Why FDA Decided to Approve Aduhelm to Treat Alzheimer’s Disease https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease

Approval Path: Aduhelm was approved under the Accelerated Pathway. According to Dr. Patrizia Cavazzoni, Director, FDA Center for Drug Evaluation and ResearchCDER Director the “Accelerated Approval https://www.fda.gov/drugs/information-health-care-professionals-drugs/accelerated-approval-program pathway, under which the FDA approves a drug for a serious or life-threatening illness that may provide meaningful therapeutic benefit over existing treatments when the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients and there remains some uncertainty about the drug’s clinical benefit.” Further, FDA consider Aduhelm a novel treatment. The last time a treatment for Alzheimer’s was approved was in 2003. Dr. Cavazzoni emphasized that “Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid beta plaques in the brain.”

Dr. Cavazzoni concluded that : “FDA will continue to monitor Aduhelm as it reaches the market and ultimately the patient’s bedside. Additionally, FDA is requiring Biogen to conduct a post-approval clinical trial to verify the drug’s clinical benefit. If the drug does not work as intended, we can take steps to remove it from the market. But hopefully, we will see further evidence of benefit in the clinical trial and as greater numbers of people receive Aduhelm.” https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease

FDA Authorizes Emergency Use for Adolescents – Pfizer-BioNTech COVID-19 Vaccine

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use

On May 10, another milestone occurred in the quest to prevent coronavirus disease commonly known as COVID-19. FDA gave the go ahead for expanded emergency use authorization (EUA) to Pfizer-BioNTech for the adolescent age group from ages 12 though 15.

According to FDA, approximately 1.5million cases of COVID-19 have occurred in that age group from March 1, 2020 through April 30, 2021.

Acting FDA Commissioner Janet Woodcock, M.D. “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

Further, on May 10, FDA recently updated the Fact Sheets for Vaccine Providers, Recipients and Caregivers- direct links:

Healthcare Providers: https://www.fda.gov/media/144413/download

Recipients and Caregivers: https://www.fda.gov/media/144414/download

FDA Matters Symposium Virtual March 24

https://delawarelaw.widener.edu/about/news-events/events/event/3681/

COVID-19 Impact on the Regulated Industry and Regulators

COVID-19-Impact on the Regulated Industry

COVID-19-Impact on the Regulated Industry
Date: November 18, 2020 
Time: Live 12:00pm (EST) / 9:00am (PST) / 17:00 (GMT) / 18:00 (CET)
Location: Webinar/Online

Join us for a unique opportunity to find out more about the COVID-19 pandemic in this nearly daily changing landscape. What you think applies today might change drastically tomorrow. This webinar will explore recent FDA activity regarding COVID-19 including an upcoming program discussion on inspections and other enforcement methods in the COVID-19 ERA. This is a Free CfPA Exclusive FREE Webinar.

Can’t make the LIVE webinar? Register now and we’ll send you a copy of the recording.

Registration Link: https://www.cfpa.com/CourseDescription/CourseDescription/2011907OL2974L/2974?utm_source=Listrak&utm_medium=Email&utm_term=Register+Now_2974&utm_campaign=2947_Free_1


Presented by: Roseann B. Termini, B.S., Ed. M., J.D. 
Ms. Termini has extensive experience in food, drug, medical devices, personal care, dietary supplement, tobacco and veterinary products regulation. Ms. Termini recently published a new comprehensive edition, both in print and E-book formats, of Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Personal Care, Veterinary and Tobacco Products (2019). Ms. Termini is also a featured speaker at international and national conferences and webinars.