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.

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:

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


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:

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

Attached Documents


Government Agencies

 Ask a question! RELX GroupLexis Nexis

Are you Eating Pop-Tarts® Whole Grain Frosted Strawberry Toaster Pastries for your On-the-Go Holiday Breakfast?

Life gets hectic over the holidays, and many choose an on-the-go breakfast. The question becomes—Are you Eating “Pop-Tarts®” for your Holiday Breakfast?  Specifically, are you eating the “Whole Grain Frosted Strawberry Toaster Pastries”? If so, take a look at the recently filed lawsuit. Here is a link to the full complaint.

PopTart-Lawsuit-NY – PDF

Russett et alia. V. Kellogg Sales Co.,  Case 7:21-cv-08572-NSR


In this multi-million dollar lawsuit there are allegations of Deception as well as False and Misleading labeling 

Here plaintiff is alleging that the front of package labelling fails to disclose that the product is not 100% Strawberry. Rather, “Pop-Tarts®”, a popular breakfast favorite, contains dried pears too! Backed up with the labelling and competitor brands the plaintiff alleges that:

1. “Kellogg Sales Company (“defendant”) manufactures, labels, markets, and sells “Whole Grain Frosted Strawberry Toaster Pastries” under its “PopTarts®” brand (“Product”). (Complaint p.1)

2. “The packaging only depicts strawberries, in words and images, and shows the Product’s bright red filling, matching the color of strawberries.“ (Complaint p.1)

3. “The strawberry representations are misleading because the Product has less strawberries than consumers expect based on the labeling.“ (Complaint p.1)

Let’s take a look at the Front of Packaging Label.

The plaintiff alleges that the name: “Whole Grain Frosted Strawberry Toaster Pastries,” is false, deceptive, and misleading, because it contains mostly non-strawberry fruit ingredients. Here is the ingredient listing descending order of prominence of each ingredient. The question is why does the product name include Strawberry when in fact it is way down on the list of ingredients and follows apples and pears? Should the product be labelled Fruit filled Toaster Pastries? How about what the complaint suggests using percentages?

Whole wheat flour, sugar, corn syrup, enriched flour (wheat flour, niacin, reduced iron, vitamin B1 [thiamin mononitrate], vitamin B2 [riboflavin], folic acid), dextrose, soybean and palm oil, bleached wheat flour, polydextrose, glycerin. Contains 2% or less of fructose, wheat starch, calcium carbonate, salt, leavening (sodium acid pyrophosphate, baking soda), vegetable juice for color, dried pears, dried apples, dried strawberries, sodium stearoyl lactylate, citric acid, modified wheat starch, DATEM, cornstarch, gelatin, xanthan gum, brown rice syrup, paprika extract color, soy lecithin, vitamin A palmitate, niacinamide, reduced iron, vitamin B6 (pyridoxine hydrochloride), vitamin B2 (riboflavin), vitamin B1 (thiamin hydrochloride). 

The lawsuit details consumer love of strawberries alleging they are the “world’s most popular berry fruit (Complaint #7. p. 2) and the label is misleading to consumers. Essentially, plaintiff alleges the product is not in federal compliance under 21 CFR sect. 102.5 which details the common or usual name.

Would a listing of percentages of fruit solve the problem?  Ex. the Complaint states:

29. “One example of this disclosure could be, “Whole Grain Frosted Strawberry Toaster Pastries – 80% Non-Strawberry, 20% Strawberry.” 21 C.F.R. § 102.5(b).” (Complaint p.7)

Here is what 21 C.F.R. § 102.5(b). 

“The common or usual name of a food shall include the percentage(s) of any characterizing ingredient(s) or component(s) when the proportion of such ingredient(s) or component(s) in the food has a material bearing on price or consumer acceptance or when the labeling or the appearance of the food may otherwise create an erroneous impression that such ingredient(s) or component(s) is present in an amount greater than is actually the case.”

The complaint depicts competitor brands— Clover Valley from Dollar Tree and Great Value from Walmart- still labelled as “Strawberry  though these companies include legal terminology of “Naturally and Artificially Flavored”.

The complaint concludes with what a reasonable consumer expects and relies on in terms of honest identification of ingredients as well as the premium price.

54. “Reasonable consumers must and do rely on a company to honestly identify and describe the components, attributes, and features of a product, relative to itself and other comparable products or alternatives.” (Complaint p.11).

60. “Similar whole grain frosted toaster pastries which have equivalent amounts of strawberries to Defendant’s Product are, or would be sold for, approximately $4.09 per box of six pouches of two pastries six pastries (20.3 oz or 576g).” (Complaint p.12).

Concluding Commentary– hard to state with certainly how this case will proceed and be decided. What do you think? Ask yourself- is the labeling accurate? Would consumers be deceived by the labeling?

CDC Recommends COVID-19 Vaccine for Pediatric Ages 5-11

CDC Director Rochelle P. Walensky, M.D., M.P.H., followed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation that children ages 5 to 11 years old be vaccinated against COVID-19 with the Pfizer-BioNTech pediatric vaccine. 

What this Means—Recommendation applies to about 28 million children in the United States in this age group

When—as soon as possible.

Risk—Direct Link

FDA Advisory Committee Votes in Favor of COVID-19 Pfizer Vaccine for Ages 5-11

The FDA’s Vaccines and Related Biological Products Advisory Committee (FDA Vaccine Advisory Committee ) voted 17-0 (one abstention) to approve the use of the COVID-19 Pfizer Vaccine for Ages 5-11 using a risk/benefit approach. If authorized, the dosage would be a lower dose than for adults.

Next Steps- FDA would have to agree with the FDA Vaccine Advisory Committee recommendation. Next the Centers for Disease Control and Prevention’s (CDC) independent advisory committee (Advisory Committee) will meet in early November and vote on whether to recommend the vaccine for this age group. Finally, CDC Director Dr. Rochelle Walensky will decide whether to accept or perhaps amend the Advisory Committee’s recommendation.

Here are Direct Links for Review:

FDA Briefing Document and Meeting
EUA amendment request for Pfizer-BioNTech COVID-19 Vaccine for use in children 5 through 11 years of age Vaccines and Related Biological Products Advisory Committee Meeting October 26, 2021 and

COVID-19 Booster Update


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.

FDA First COVID-19 Vaccine Approval Comirnaty August 23, 2021


Approval Letter

Package Insert

FAQ for Comirnaty (COVID-19 Vaccine mRNA)

Press Release:

Indication and Approval: The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” 

According to FDA “Comirnaty contains messenger RNA (mRNA), a kind of genetic material, used by the body to make a mimic of one of the proteins in the virus that causes COVID-19.” “The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material.” Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart. 

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”

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

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 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.”

Emergency Use Authorization vs. Approval and Other Key Terminology

Following Pfizer BioNTech’s Biologics License application, Moderna filed a Biologics License application. Currently Pfizer BioNTech and Moderna were granted Emergency Use Authorization Status.

Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19

See links or read below.

“There’s a lot of confusion about which medical products might work to prevent or treat coronavirus disease 2019 (COVID-19). Scientists are working hard to develop a number of potential drugs for the prevention or treatment of coronavirus.The FDA recently approved the first treatment for COVID-19, the antiviral drug remdesivir. Some other investigational drugs are already in clinical trials. In some cases, scientists are testing whether drugs that are already approved for a different disease are safe and effective against COVID-19.As studies continue, these drugs are sometimes made available to patients through the FDA’s Expanded Access Program, or under an Emergency Use Authorization. Health care providers may also decide to treat a patient with a drug that has been approved by the FDA for one use, but not for the patient’s disease or condition (sometimes called “off-label” use).If you think you have, or have had, COVID-19, your health care provider has a complete picture of your health and health history and can help you make the best decisions for your care.The language used to describe potential therapies can be confusing, and there’s public interest around the FDA’s work to ensure access to potentially life-saving treatments. Here’s what those terms mean.

What “FDA Approved” Means

U.S. consumers rely on the FDA to provide independent scientific reviews of medical products, including drugs and vaccines. During this public health emergency, there is an urgent need for products to treat or prevent the virus that causes COVID-19. Before the FDA can approve a drug, the agency must determine whether the clinical data and other information show that the drug is safe and effective for its intended use (for example, to prevent or treat a certain disease), and that the product can be made according to federal quality standards.When the FDA approves a drug, it means the agency has determined, based on substantial evidence, that the drug is effective for its intended use, and that the benefits of the drug outweigh its risks when used according to the product’s approved labeling.The FDA is working with manufacturers and researchers to make sure the agency is getting the information needed to complete that evaluation for drugs to treat or prevent COVID-19 as quickly as possible.

Investigational Treatments

An investigational drug can also be called an experimental drug. Scientists conduct clinical trials to study investigational drugs to see if they can safely and effectively prevent or treat a specific disease or condition. As part of those clinical trials, they might try to discover:

  • How the drug might be used for that disease or condition.
  • If the drug is safe for people.
  • How much of the drug is needed. 
  • Information about whether it works against the disease and the potential benefits and risks of taking the drug.

Expanded Access

Sometimes called “compassionate use,” expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biological product, or medical device) for treatment outside of clinical trials when there is no comparable or satisfactory alternative therapy.

Currently, expanded access is one pathway for use of COVID-19 convalescent plasma for patients with serious or immediately life-threatening COVID-19 disease who are not eligible for or who are unable to participate in randomized clinical trials.

Limited information suggests that convalescent plasma – an antibody-rich product made from blood donated by people who have recovered from the virus – may help COVID-19 patients. Because current information is limited, it’s important to evaluate this therapy in the context of a clinical trial.

Emergency Use Authorization (EUA)

An Emergency Use Authorization (EUA) is one of several tools the FDA is using to help make certain medical products available quickly during the COVID-19 pandemic. In certain emergencies, the FDA can issue an EUA to provide access to medical products that may potentially be used when there are no adequate, approved, and available options.

The EUA process is different than an FDA approval or clearance. Under an EUA, in an emergency, the FDA makes a product available to the public based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance.

When evaluating an EUA, we carefully balance the potential risks and benefits of the products based on the data currently available. 

EUAs are effective until the emergency declaration ends. EUAs can also be revised or revoked by the FDA at any time as we continue to evaluate the available data and patient needs during the public health emergency.

The FDA has granted EUAs to a few possible COVID-19 therapies. Learn more about EUAs in this videoExternal Link Disclaimer.

“Off-Label” Use: Unapproved Uses of Approved Drugs

Once the FDA has approved a drug for a disease or medical condition, health care providers generally may prescribe or administer the drug in clinical practice for an unapproved use not described in the approved labeling (i.e., “off-label”) based on their medical judgment, recognizing that the FDA has not assessed the safety or effectiveness of such use.”