Coronavirus (COVID-19) Update: Daily Roundup July 31, 2020

The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic: As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to one company for selling fraudulent COVID-19 related products. The company, Vapore, LLC, dba Mypurmist, sells Mypurmist with misleading claims that the product can mitigate, prevent, treat, diagnose, or cure COVID-19 in people. There are currently no FDA-approved products to prevent or treat COVID-19. FDA requested that Vapore, LLC, immediately cease selling this unapproved and unauthorized product. Consumers concerned about COVID-19 should consult with their health care provider. Testing updates: To date, the FDA has currently authorized 194 tests under EUAs; these include 159 molecular tests, 33 antibody tests, and 2 antigen tests

Resources for Animal Food Producers in Puerto Rico and the Southeastern U.S. Affected by Hurricane Isaias

As Hurricane Isaias approaches Puerto Rico and the Southeastern United States, the U.S. Food and Drug Administration’s Center for Veterinary Medicine reminds those who may be affected about resources available for animal food producers who may be harvesting, mixing, storing or distributing grains and other foods for animals. The FDA reminds harvesters that crops harvested from flooded fields are often unacceptable because of contamination. Flood waters, which are different from pooled rain water, may contain sewage, pathogenic organisms, pesticides, chemical wastes, or other toxic substances. Mold growth is another serious concern for flood impacted crops intended for use in animal food. Some molds produce mycotoxins, which are toxic to certain animals and people.

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Coronavirus (COVID-19) Update: Daily Roundup July 29, 2020

The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic: On July 28, the FDA updated the Molecular Diagnostic templates. The Molecular Diagnostic templates include recommendations for laboratories and commercial manufacturers who may use the templates to help facilitate the preparation and submission of requests for emergency use authorizations (EUAs). The updates are regarding diagnostic tests for use with sample pooling, at the point of care, and in the detection and differentiation of SARS-CoV-2 and other respiratory pathogens such as viruses that cause influenza. Today, the FDA posted a new template for commercial manufacturers to help facilitate the preparation and submission of emergency use authorization (EUA) requests for prescription or non-prescription COVID-19 diagnostic tests that can be performed entirely outside of a laboratory, such as at home, in schools or in other non-lab settings. Testing updates: To date, the FDA has currently authorized 193 tests under EUAs; these include 158 molecular tests, 33 antibody tests, and 2 antigen tests.

FDA Warns Companies Illegally Selling Hangover Remedies

Today, the U.S. Food and Drug Administration announced it has issued warning letters to seven companies for illegally selling unapproved products labeled as dietary supplements that claim to cure, treat, mitigate or prevent hangovers, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The warning letters were issued to: Double Wood LLC; Ebnsol Inc.; Vita Heaven LLC (doing business as Hangover Heaven); Happy Hour Vitamins; LES Labs; Mind, Body & Coal LLC; and Purple Biosciences LLC. “Dietary supplements that claim to cure, treat, mitigate or prevent hangovers could potentially harm consumers, especially young adults,” said Steven Tave, director of the FDA's Office of Dietary Supplement Programs. “Consumers may get the false impression that using these products can prevent or mitigate health problems caused by excessive drinking. Dietary supplements are not a substitute for responsibly limiting one’s alcohol consumption.” Under the FD&C Act, products intended to cure, treat, mitigate or prevent disease are drugs and are subject to the requirements that apply to drugs. Unlike drugs approved by the FDA, there has been no FDA evaluation of whether these unapproved products are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs, or...

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Kodak Shifts Into Drug Production With Help of a $765 Million U.S. Loan

Kodak Shifts Into Drug Production With Help of a $765 Million U.S. Loan

Wall Street Journal· 7 hours ago

The photography pioneer won a government loan under the Defense Production Act to help expedite...

Kodak stock triples on $765 million government loan — for ...

www.mynbc5.com/article/kodak-stock-triples-on...

Jul 28, 2020 · Kodak stock soared Tuesday morning after it won a a $765 million U.S. government loan to help produce pharmaceutical ingredients — part of an effort to reduce dependence on foreign drug makers ...

• Giant federal loan to Kodak could boost drug production in U.S. — and hiring in St. Paul

  The Business Journals· 1 hour ago
  Eastman Kodak Co., the venerable maker of photographic film, is getting into the drug production...

• Kodak Gets $765M Government Loan for Generic Drugs Production

  TheStreet.com· 4 hours ago
  Kodak is receiving a $765 million loan from the International Development Finance Corp. to make ingredients for drugs.

Coronavirus (COVID-19) Update: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products

Agency Urges Consumers, Health Care Professionals Not to Use Certain Products, Citing Serious Adverse Events and Death

The U.S. Food and Drug Administration continues to warn consumers and health care professionals not to use certain alcohol-based hand sanitizers due to the dangerous presence of methanol, or wood alcohol – a substance often used to create fuel and antifreeze that can be toxic when absorbed through the skin as well as life-threatening when ingested. The agency has also taken additional action to help prevent certain hand sanitizers from entering the United States by placing them on an import alert. The FDA is proactively working with manufacturers to recall products and is encouraging retailers to remove products from store shelves and online marketplaces. As part of these actions, a warning letter has been issued to Eskbiochem S.A. de C.V. regarding the distribution of products labeled as manufactured at its facilities with undeclared methanol, misleading claims –including incorrectly stating that FDA approved these products—and improper manufacturing practices.

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Trump issues drug pricing executive orders on 340B, international drug pay

President Donald Trump signed four executive orders to advance policies on passing through some 340B discounts, tying Medicare payment for outpatient drugs to international prices, passing drugmaker rebates to patients and importation.

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Coronavirus (COVID-19) Update: Daily Roundup July 24, 2020

The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic: The U.S. Food and Drug Administration (FDA) issued an updated FDA COVID-19 Response At-A-Glance Summary that provides a quick look at facts, figures, and highlights of the agency's response efforts. FDA maintains up-to-date webpages on COVID-19-related resources including its searchable database of medical devices that have been issued emergency use authorizations during the pandemic. Testing updates: To date, the FDA has currently authorized 188 tests under EUAs; these include 155 molecular tests, 31 antibody tests, and 2 antigen tests.

Recall Alert: FDA MedWatch Safety Alert: Dexmedetomidine Hydrochloride Injection by Fresenius Kabi

CVM is sharing this recall announcement because these products may be used in veterinary settings. TOPIC: Dexmedetomidine Hydrochloride Injection by Fresenius Kabi: Recall - Due to Cross - Contamination of Lidocaine AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy ISSUE: Fresenius Kabi is recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg/mL), 50 mL fill in a 50 mL vial due to the possible presence of trace amounts of lidocaine in these two lots based on FDA investigation. Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy could result in anaphylaxis, a potentially life-threatening condition. To date, no adverse drug experience reports have been received for either of the lots being recalled by Fresenius Kabi. BACKGROUND: Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is approved for intravenous use and indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. List of recalled lots and product photos below:

RECOMMENDATION: Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

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FDA Proposes New Rule on Reporting Requirement Under Right to Try Act

FDA Proposes New Rule on Reporting RequirementUnder Right to Try Act

Today, the U.S. Food and Drug Administration published the proposed rule, Annual Summary Reporting Requirements Under the Right to Try Act, that when finalized, will implement a statutory requirement for sponsors and manufacturers to provide an annual summary to the FDA for any eligible investigational drug they provide to eligible patients under the Right to Try Act. “The FDA is dedicated to achieving the goals that Congress set forth in the Right to Try Act, so that patients facing terminal conditions have another avenue to access investigational medicines,” said Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs. “Today’s proposed rule builds on the FDA’s long-standing dedication to enhancing access for patients who are facing life-threatening diseases or conditions and our continued commitment to transparency.” The Right to Try Act, or the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2017, provides a pathway for patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a clinical trial, to access certain unapproved treatments. Ultimately, the sponsor or manufacturer who is developing the drug or biologic, not the FDA, is responsible for determining whether to make their product available to patients who qualify for access under the Right to Try Act.

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