Specialty Pharma Industry News is provided by SPA Member Dr. Larry Boos
June 30
Warning Letters
Homecare Laboratories, Inc. E. Scheiner President, 7 Odell Plaza, Suite 142, Yonkers, NY 10701
Our recent inspection revealed that your methods, facilities, or controls for manufacturing, processing, packing or holding do not conform to CGMP, consequently your product are adulterated within the meaning of the FD&C Act. Among other failures:
1. Your firm failed to have appropriate laboratory determination of conformance to specifications for your drug products.
2. Your firm failed to test samples of each incoming component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Also you failed to validate and establish the reliability of your component supplier's test results.
3. Your firm failed to clean and maintain equipment at appropriate intervals.
4. Your firm failed to establish adequate written procedures for production and process control.

Outoftheboxremedies.com, J Burket, 66/3 Emek Hahula, Modin 71703 Israel
The FDA has observed that your website offers iodine products (such as "Coronavirus Terminator") for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the FD&C Act and furthermore these products are misbranded under section 502 of the FD&C Act.

Editor's Note: the above company is an example of just one of the 60 Warning Letters sent out since April 1 concerning unapproved and misbranded products related to Coronavirus Disease 2019 (COVID-19)

The FDA has approved pembrolizumab for colorectal cancer.  Pembrolizumab (KEYTRUDA, Merck & Co.) has been approved for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.  The recommended pembrolizumab dose for MSI-H/dMMR colorectal cancer is 200 mg every 3 weeks or 400 mg every 6 weeks.

Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry
Download at https://www.fda.gov/media/128651/download The Food and Drug Administration Safety and Innovation Act (FDASIA) amended the REMS modification provisions under section 505-1(g) and (h) of the FD&C Act.
June 23
NIH: Universal Mosquito Vaccine Tested.  A small trial showed that a vaccine designed to provide broad protection against mosquito-borne diseases is safe and causes a strong immune response in healthy volunteers.  When a mosquito bites you, compounds in its saliva interact with your body's initial immune response to help pathogens evade your body's disease defenses.  Although there are vaccines being studied for individual mosquito-borne diseases-like malaria, West Nile virus, and dengue fever-a vaccine against mosquito saliva could provide broader protection against many diseases.   More research is needed before it can be used for the public at large.
June 22
Food and Coronavirus Disease 2019 (COVID-19 )   Coronaviruses, like the one that causes COVID-19, are thought to spread mostly person-to-person through respiratory droplets when someone coughs, sneezes, or talks.   It is possible that a person can get COVID-19 by touching a surface or object, including food or food packaging, that has the virus on it and then touching their own mouth, nose, or possibly their eyes. However, this is not thought to be the main way the  virus spreads .   Currently there is  no evidence to suggest that handling food or consuming food is associated with COVID-19.    Remember, it is always important to follow good  food safety practices  to reduce the risk of illness from common foodborne pathogens.  The virus that causes COVID-19 has not been found in drinking water.

June 19
Recall:  Children's Robitussin Honey Cough and Chest Congestion DM (Lots 02177 & 02178) and Children's Dimetapp Cold and Cough (Lot CL8292) by GSK Due to Dosing Cups Missing Graduation Markings.  There is potential risk of accidental overdose if the discrepancies are not noted between graduations printed on the dosing cups and the amounts administered (if following instructions for use).
June 16
Patient-Focused Drug Development: Collecting Comprehensive and Representative Input Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders     This guidance (Guidance 1) is the first of a series of four methodological patient-focused drug development (PFDD) guidance documents3 that FDA is developing to address, in a stepwise manner, how stakeholders (patients, researchers, medical product developers and others) can collect and submit patient experience data4 and other relevant information from patients and caregivers for medical product5 development and regulatory decision making.  Download by Control/Click on the colored title above or on:  https://www.fda.gov/media/139088/download

FDA Warns Four Manufacturers of Unapproved Injectable Drugs Labeled as Homeopathic.  
The FDA issued the warning letters to  Hevert Pharmaceuticals, LLC; MediNatura, Inc.; 8046255 Canada, Inc., doing business as Viatrexx; and World Health Advanced Technologies, Ltd.   The products included in the warning letters are new drugs because they are not generally recognized as safe and effective for their labeled uses, and FDA has not approved these products.   Many of the drugs were labeled to contain potentially toxic ingredients such as nux vomica, belladonna (deadly nightshade), mercurius solubilis (mercury), and plumbum aceticum (lead). For example, nux vomica contains strychnine, which is a highly toxic, well-studied poison that is used to kill rodents.
June15
Remdesivir by Gilead Sciences: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of Treatment of COVID-19.     FDA is warning health care providers that co-administration of remdesivirand chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir.   The safety and efficacy of remdesivir for the treatment of COVID-19 continue to be evaluated, and preliminary clinical trial results have shown that on average, patients treated with remdesivir had more rapid time to recovery.
June 11
Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of One Lot of Metformin Hydrochloride Extended-Release Tablets USP, 500mg Due to the Detection of N-Nitrosodimethylamine (NDMA)   Lupin Pharmaceuticals Inc. is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets USP (generic equivalent of Fortamet®), 500mg, lot G901203 to the consumer level. FDA analysis revealed that this lot exceeded the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA).  NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. To learn more Control/Click on the title above.
June 7
Metformin Hydrochloride Extended-Release Tablets USP 750 mg by Granules Pharmaceuticals: Recall - Due to the Detection of N-Nitrosodimethylamine (NDMA).  This is the same situation as with Lupin Pharmaceuticals above.
June 5
Metformin Hydrochloride Extended-Release 500 mg and 750 mg Tablets by Teva and Amneal Pharmaceuticals and 500 mg Tablets by Marksans Pharma: Recall - Due to the Detection of  N-Nitrosodimethylamine (NDMA).  These are the same situations  as with Lupin Pharmaceuticals above.

Report on the State of Pharmaceutical Quality, 2019      To download Control/Click on the title.
June 3
FDA Publishes Product-Specific Guidance (PSGs) to Facilitate Generic Drug Development.
Today, FDA published a new batch of 69 product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support Abbreviated New Drug Application (ANDA) approval, thereby helping to streamline generic drug product development by industry and ANDA assessment by FDA. Control/Click on the colored description above to learn which guidance have been created.
June 1
A federal judge has ordered Rahsan Hakim and Adoni-iah Rahsan doing business as Sundial Herbal Products to stop distributing unapproved new drugs and misbranded drugs until they comply with federal law. According to the complaint, despite previous warnings from the U.S. Food and Drug Administration and repeated promises to correct violations, Sundial continued to violate the law and distribute their products.   the FDA has not approved any application for any of Sundial's drugs, despite Sundial claiming that their products can cure, treat, or prevent a wide variety of diseases, including syphilis, cancer, and HIV/AIDS. For example, Sundial claimed that its Sundial Organic Hemp Seed Oil "suppresses the growth of cancer" and that Sundial Cassava Meal "prevents heart disease."  This action follows multiple FDA inspections conducted at Sundial between 2012 and 2017. The FDA issued a warning letter  to Sundial in 2013 for similar violations. Despite assurances that the violations noted in the warning letter would be corrected, follow-up inspections revealed that the defendants did not make the necessary corrections.  To read warning letter Control/Click on the colored link above.