August 28-29 * 4th Annual Regulatory Workshop
Offices of Buchanan Ingersoll & Rooney * Washington, D.C.

Regestration is now open. 
Visit our website to register and for agenda details.
Specialty Pharma Industry News is provided by SPA Member Dr. Larry Boos

June 28
FDA warns patients and health care professionals not to use sterile products from Pacifico National Inc., dba AmEx Pharmacy due to a lack of sterility assurance. FDA investigators recently inspected AmEx Pharmacy's facility in May 2019 and observed conditions that could cause AmEx Pharmacy's drugs to become contaminated or otherwise pose risks to patients.

Outbreak Investigation of Salmonella Uganda Potentially Linked to Whole, Fresh Papayas from Mexico. These illnesses have been reported in eight states: Connecticut, Massachusetts, New York, New Jersey, Pennsylvania, Rhode Island, Florida, and Texas. Retailers, restaurants, and other food service providers in those states should not serve or sell whole, fresh papayas imported from Mexico, until more is known about this outbreak.

FDA seeks to advance safe and effective prostate tissue ablation devices by outlining clinical study recommendations for manufacturers. The FDA issued a draft guidance to provide recommendations for device manufacturers regarding the clinical testing that must be conducted in accordance with special controls for high intensity ultrasound systems for prostate tissue ablation devices regulated under the agency's 510(k) premarket notification program. This draft guidance also outlines recommended clinical data to support marketing submissions for prostatic tissue ablation devices that use newer, more innovative technologies or forms of energy to ablate (or destroy) prostate tissue. Control/Click on title above to reach the download link.

June 27 
Central Aquatics of Franklin, Wisconsin is recalling 96 cases of Aqueon Betta Food (item number 100106051 sold in a .95 ounce jar) because it has the potential to be contaminated with Salmonella. Fish with Salmonella infections are not well documented and fish carrying salmonella typically do not show any signs of disease. The Aqueon Betta Food, that is the subject of this recall, was distributed to Georgia, Illinois, New Jersey, and Pennsylvania via distribution centers.

The U.S. Food and Drug Administration is warning patients and health care providers that certain Medtronic MiniMed insulin pumps are being recalled due to potential cybersecurity risks. It recommends that patients using these models switch their insulin pump to models that are better equipped to protect against these potential risks. Cybersecurity vulnerabilities could allow a person to over deliver insulin to a patient, leading to low blood sugar (hypoglycemia), or to stop insulin delivery, leading to high blood sugar and diabetic ketoacidosis (a buildup of acids in the blood).

Food and Drug Administration is providing an update on its investigation into reports of dilated cardiomyopathy (DCM) in dogs eating certain types of pet food. As part of this update, the FDA is sharing a compilation of adverse event reports of DCM submitted to the agency through April 30, 2019, an updated case count, and new testing results. For the first time, the agency is also posting the pet food brands most frequently identified in these adverse event reports. This website shows breeds most reported along with other important information.

CDC Reports that Minorities and Women are at Greater Risk for Alzheimer's Disease. Hispanic and African Americans in the United States will see the largest increases in Alzheimer's disease and related dementias between 2015 and 2060. Cases among Hispanics will increase seven times over today's estimates while cases among African Americans will increase four times over today's estimates. Among all races, women are nearly two times more likely to be affected by Alzheimer's disease than men.1,2 The difference is due primarily to women living longer.

June 26
Draft Guidance M10 BIOANALYTICAL METHOD VALIDATION Control/Click to reach the download link.

Draft Guidance E19 OPTIMISATION OF SAFETY DATA COLLECTION Control/ Click to reach the download link.

The following products contain hidden drug ingredients: Peru Maca, Germany Black Gorilla, Adelgasin Plus, Super Slimming Herb, Lishou Fuling Jiaonang, Detoxi Slim, and Absolute Nine Slim. Usually the hidden drug is sildenafil, the active ingredient in Viagra or sibutramine, a controlled drug which was removed from the market for safety reasons in October 2010.

Macleods Pharmaceuticals Limited has initiated a voluntary recall in the United States, to the patient level, of Losartan Potassium USP Tablets and Losartan Potassium/Hydrochlorothiazide combination Tablets due to an unexpected impurity in the active pharmaceutical ingredient (API) Losartan Potassium. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out.

The CDC has announced that the outbreak investigation of Salmonella Concord Linked to Tahini appears to be over. The FDA has concluded its investigational activities related to this outbreak. Tahini is made from sesame seeds and can be served on its own or used as an ingredient in Mediterranean and Middle Eastern style dishes, such as hummus, falafel, and baba ganoush.

Warning Letters
Pamela Montgomery, President, Chukar Cherry Company, Prosser, Washington 99350  The FDA inspected your chocolate confection production facility in November 2018, in response to a consumer complaint regarding an allergic reaction. Although milk is not used as an ingredient in your dark chocolate covered nut and fruit products, the FDA found elevated levels of milk protein in these products. We have determined that your dark chocolate covered nut and fruit products are adulterated in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. The bittersweet chocolate you received from your supplier contained an advisory statement on the label which cautions that the product is "made on equipment also used to make milk chocolate; not suitable for individuals with milk allergies."

Arun Kumar, CEO, Strides Pharma Science Limited, Bangalore 560076, India
During our inspection, our investigators observed specific violations including, but not limited to, the following.
1. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug product.
2. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.

June 25
FDA issues warnings to companies selling illegal, unapproved kratom drug products marketed for opioid cessation, pain treatment and other medical uses. Cali Botanicals of Folsom, California, and Kratom NC of Wilmington, North Carolina - have been cited for illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms.

Gut-Dwelling Bacterium Consumes Parkinson's Drug NIH Scientists continue to uncover the many fascinating ways in which the trillions of microbes that inhabit the human body influence our health. Now comes yet another surprising discovery: a medicine-eating bacterium residing in the human gut that may affect how well someone responds to the most commonly prescribed drug (levodopa) for Parkinson's disease. A a bacterium called Enterococcus faecalis, which commonly resides in a healthy gut microbiome was found to avidly consume L-dopa, using its own version of a decarboxylase enzyme. When a specific gene in its genome was inactivated, E. faecalis stopped breaking down L-dopa.

Recall: Parent's Choice Advantage Infant Formula Milk-Based Powder With Iron by Perrigo Due to Potential Presence of Metal Foreign Material. This product was exclusively sold at Wal-Mart. Consumers who may have purchased the product should look for Lot Code C26EVFV with a "use by" date of February 26, 2021, which can be found on the bottom of the package. Any consumers who purchased the product should discontinue use and can visit any Walmart store for a refund.

June 24
the U.S. Food and Drug Administration (FDA) has published an update to the "List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic." The list includes approved new drug applications (NDAs) for drug products that are not protected by patents or exclusivities at the time of the update, and for which the FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA product. Both PDF and Excel formats are available for the current update and all previous updates. Control/Click on the blue title above to learn which products are on the list.

Keurig Dr Pepper Announces Voluntary Withdrawal of Unflavored Penafiel Mineral Spring Water that Does Not Meet FDA Bottled Water Quality Standards. Keurig Dr Pepper today announced it will voluntarily withdraw Peñafiel unflavored mineral spring water products, imported from Mexico, due to the presence of violative levels of arsenic. Arsenic when present in the diet at very high levels is associated with numerous chronic diseases.

FDA In Brief: FDA issues new draft guidance to improve the safety of seeds for sprouting. The U.S. Food and Drug Administration today released a proposed draft guidance, "Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting," intended to make the sprout seed industry (seed growers, conditioners, packers, holders, suppliers, and distributors) aware of the agency's serious concerns with the continuing outbreaks of foodborne illness associated with the consumption of raw and lightly-cooked sprouts.

June 21 
The U.S. Food and Drug Administration today approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. "There are women who, for no known reason, have reduced sexual desire that causes marked distress, and who can benefit from safe and effective pharmacologic treatment. HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. 

Brand Castle, LLC, of Bedford Heights, Ohio, recalled several brands of cookie and brownie mix because flour used in them was potentially contaminated with E. coli. Due to potential contamination with E. coli O26, do not eat any raw cake mix, batter, or any other raw dough or batter product that is supposed to be cooked or baked.

FDA Investigated Shigella Illnesses Linked to Imported Raw Oysters. As of June 21, 2019 the CDC has announced that this outbreak appears to be over. The FDA has concluded that all potentially contaminated product has been recalled and the growing area of Estero El Cardon, Baja California Sur, Mexico was reopened on June 13, 2019.

Recently Posted Guidance Documents
C&S Wholesale Grocers, Inc. ("C&S") is voluntarily recalling a number of perishable items sold at two Target stores. One store is located at 98 Veterans Memorial Highway in Commack, New York and the other is located at 160 North Research Place in Central Islip, New York. The products were not held at an appropriate temperature due to a mechanical malfunction during C&S transportation and may be unsuitable for human consumption. The recall includes items listed in the attached that were sold on June 17, 2019. No illnesses have been reported to dat

In cooperation with ADM Milling Co., Brand Castle, LLC of Bedford Heights, Ohio is voluntarily recalling 25 oz and 32 oz glass jars of cookie and brownie mix out of an abundance of caution because it may be contaminated with pathogenic E. coli.

T oday, the FDA published the guidance for industry entitled, Providing Regulatory Submissions in Electronic and Non-Electronic Format - Promotional Labeling and Advertising Materials for Human Prescription Drugs. Under Section 745A(a) of the FD&C Act, no sooner than 24 months after this guidance is issued, the FDA will require that specific promotional materials be submitted to the FDA in electronic format. 

Alma Pak of Alma, Georgia is recalling specific lots of product containing frozen blackberries due to the potential of being contaminated with Norovirus. FDA testing of frozen blackberries was reported to have tested positive for Norovirus. Norovirus is a highly contagious virus. Consumption of product contaminated with Norovirus may cause acute onset of symptoms of gastroenteritis including severe nausea, vomiting and diarrhea. Less common symptoms are low-grade fever, chills, headache, muscle aches and fatigue.

June 20 
UNFI Recalls its Woodstock Frozen Organic Grilled Red Peppers Because of Possible Health Risk of Listeria Monoctogenes. This organism can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Premier Pharmacy Labs and RXQ Compounding, LLC Issue Voluntary Nationwide Recalls Due to the Lack of Sterility Process Assurance. Find details at Premier Pharmacy Labs or Find details at RXQ Compounding, LLC. 

June 19 
What You Need to Know (And What We're Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD. You may have noticed that cannabidiol (CBD) seems to be available almost everywhere, and marketed as a variety of products including drugs, food, dietary supplements, cosmetics, pet food, and other animal health products. The U.S. Food and Drug Administration (FDA) recognizes the significant public interest in cannabis and cannabis-derived compounds, particularly CBD. However, there are many unanswered questions about the science, safety, and quality of products containing CBD. The Agency is working on answering these questions through ongoing efforts including feedback from a recent FDA hearing and information and data gathering through a public docket that is open for comment until July 16, 2019. ..continue reading

All Unexpired Sterile Drug Product Lots by Premier Pharmacy Labs: Recall - Due to Lack of Sterility Assurance. The unexpired sterile drug product lots are being recalled due to concerns presented during the latest FDA inspection including insufficient environmental controls, potential cross contamination and lack of product specific process validations.
 
Mai Cuisine Inc., of Philadelphia, PA is voluntarily recalling 31 packs of Spicy Shrimp Tempura Roll and 32 packs of Spicy Shrimp Tempura Crunch Roll because it may contain undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume these products. Read more...

June 18 
NATURE'S TOUCH FROZEN FOODS (WEST) INC. ("Nature's Touch") is voluntary recalling Signature Select Avocado Chunks, with a best before date of Oct 11, 20, due to potential contamination with Listeria monocytogenes (the "Product").

Nature's Touch is issuing this voluntary recall based on strict precautionary measures after the company was informed by the FDA that a routine sampling program found a positive result for Listeria monocytogenes. The Product was distributed in the States of Alaska, Arizona, California, Colorado, Hawaii, Idaho, Nebraska, Nevada, New Mexico, Oregon, South Dakota, Washington, Wyoming, Texas and Utah and at these following banner stores: Albertsons, Safeway, Safeway Community Markets, Carrs-Safeway, Eagle, Lucky, Pak N Save, Pavilions, and Vons.

FDA to provide new data regarding eligibility for 180-day exclusivity. As part of its ongoing efforts to provide transparency and assist generic drug applicants with planning regarding their applications, the Food and Drug Administration (FDA or the Agency) regularly publishes a list - the Paragraph IV Patent Certifications list - that contains information relevant to eligibility for 180-day exclusivity for generic drug products under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Sprouts Farmers Market Recalls Frozen Cut Leaf Spinach and Frozen Organic Cut Leaf Spinach 16 ounce Packages Because of Possible Health Risks. These products have the potential to be contaminated with Listeria monocytogenes an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Registration Open: Clinical Investigator Training Course - Nov. 12-14, 2019. This course provides an intermediate-level study of clinical trial principles with in-depth coverage of clinical trial design, issues in safety and efficacy, investigator responsibilities, understanding the investigator brochure, and FDA requirements across centers. Register at: http://www.fda.gov/cdersbia | http://www.fda.gov/cderlearn

Artificial light during sleep linked to obesity Researchers found that women who slept with a television or light on were more likely to gain weight and develop obesity. People are exposed to light at night in many different ways, including from television, mobile devices, streetlights, and other sources of light. Studies in animals suggest that being exposed to light at night may affect melatonin, leading to changes in circadian rhythms and weight gain from altered eating patterns.

FDA granted accelerated approval to pembrolizumab (KEYTRUDA, Merck) for patients with metastatic small cell lung cancer (SCLC). Read more at https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-metastatic-small-cell-lung-cancer

June 17 
Hometown Food Company, in cooperation with ADM Milling Co., today initiated a voluntary recall of two specific lot codes of its Pillsbury® Best 5 lb. Bread Flour due to a potential presence of pathogenic E. coli. Young children, elderly individuals, pregnant women and those who are immunocompromised are more susceptible to foodborne illness. The severity of E. coli infections vary among people and often include several symptoms, including severe stomach cramps, diarrhea (often bloody) and vomiting.

WinCo Foods, LLC. Of Boise, ID is recalling Frozen Red Raspberries, 12 ounce bag, manufactured by Rader Farms of Bellingham, WA, because it has the potential to be contaminated with Norovirus. Norovirus is a highly contagious virus. Typical symptoms of norovirus infection are acute onset of vomiting, watery, non-bloody diarrhea with abdominal cramps, and nausea.

Shivam Distribution Recalls "Dry Dates" Because of Possible Health Risk. Shivam Distributors of Longwood, FL is recalling its 14-ounce packages of "Dry Dates" because they contain high sulfite content a preservative which could cause adverse health consequences with symptoms such as itchiness, upset stomach, headache, stiffness, diarrhea, cough, nausea and weakness. The recall was the result of a random testing done on May 21 2019 by FL agriculture department which notified our company on June 5, 2019 that revealed high sulfite level in the 14 ounce packages of "Dry Dates" with batch # 127/BHBI.

Frito-Lay Issues Voluntary Allergy Alert on Undeclared Milk in Lay's Lightly Salted Barbecue Flavored Potato Chips. Frito-Lay today issued a limited voluntary recall of 7 3/4 oz. bags of Lay's Lightly Salted Barbecue Flavored Potato Chips because they may contain undeclared milk ingredients. The products covered by this recall were distributed in retail locations in the following states: Arkansas, Arizona, California, Colorado, Idaho, Iowa, Kansas, Louisiana, Minnesota, Missouri, Mississippi, Montana, North Dakota, Nebraska, New Mexico, Nevada, Oklahoma, Oregon, South Dakota, Tennessee, Texas, Utah, Washington and Wyoming. he recalled products have both a "Guaranteed Fresh" date of 27 AUG 2019 and a nine-character manufacturing code that includes the numbers "29" in the second and third position (example: x29xxxxxx) listed below the "Guaranteed Fresh" date.

June 14 
Adulterated Dietary Supplements Seized from Life Rising Corporation due to poor Manufacturing Practices. The U.S. District Court for the Northern District of Illinois determined there was probable cause that the company prepared, packed, and/or held dietary supplements under conditions that do not conform to the dietary supplement current good manufacturing practice (CGMP) requirements. The seized goods including tablets, capsules, and teas which were held by Life Rising or manufactured in the company's facility located in Willowbrook, Ill., consisted of more than 500 products bearing brand names Life Rising, Holicare, or HopeStream, and are valued at approximately $3.5 million

June 12 
Townsend Farms, Inc. Notifies Costco of Possible Health Risk and Recalls Conventional Frozen Kirkland Three Berry Blend. A recent FDA test indicated that a domestic conventional frozen blackberry product manufactured by Townsend Farms, Inc., may be contaminated with Hepatitis A. Townsend Farms, Inc. used the domestic conventional frozen blackberry to manufacture the Kirkland Signature Three Berry Blend product with Best By Dates between February 16, 2020, and May 4, 2020.

Losartan Potassium to 50 mg and 100 mg Tablets USP by Teva Pharmaceuticals USA: Expanded Recall. Teva Pharmaceuticals USA, Inc. has expanded its voluntary consumer-level recall originally initiated on April 25, 2019 in the United States of losartan potassium tablets. This expanded recall includes 6 lots of bulk losartan potassium USP Tablets due to the detection of an impurity - N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) - that is above the FDA's interim acceptable exposure limit of 9.82 ppm.

June 11
FDA Approves Pembrolizumab (Keytruda, Merck) for HNSCC. FDA approved pembrolizumab (KEYTRUDA, Merck) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC). For more information go to https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-first-line-treatment-head-and-neck-squamous-cell-carcinoma

June 10 
Glutathione L - reduced Powder by Letco Medical: FDA Warned Compounders Not to Use Product to Compound Sterile Injectable Drugs. FDA warned compounders on February 1, 2019, not to use glutathione L-reduced powder (L-glutathione) distributed by Letco Medical located in Decatur, Alabama, to compound sterile injectable drugs. FDA received a report concerning seven patients who received an injectable drug compounded with L-glutathione and experienced adverse events due to potentially high levels of endotoxins, a substance that may cause unintended health consequences ranging from fever to death. The L-glutathione powder the pharmacies received was labeled with "Caution: Dietary Supplement" and should not have been used to compound sterile injectable drugs.

Kroger Recalls Select Frozen Private Selection Berries for Possible Health Risk. Kroger is recalling Private Selection Frozen Triple Berry Medley (48 oz), Private Selection Frozen Triple Berry Medley (16 oz), and Private Selection Frozen Blackberries (16 oz) manufactured by Townsend Farms due to possible Hepatitis A contamination. Hepatitis A is a contagious liver disease that results from exposure to the Hepatitis A virus, including from food. It can range from a mild illness lasting a few weeks to a serious illness lasting several months. Illness generally occurs within 15 to 50 days of exposure and includes fatigue, abdominal pain, jaundice, abnormal liver tests, dark urine and pale stool.

June 7
FDA Advises Consumers to Stop Using Infant Formula from Bobbie Baby, Inc. This product was manufactured in, Germany and imported into the United States. The FDA advises parents and caregivers to stop using and buying this formula because these products do not provide adequate nutrient levels for some infants, particularly for infants born prematurely or with a low birth weight, having low iron levels at birth or at risk for becoming iron deficient due to illness. If untreated it may have irreversible cognitive and functional development outcomes.

Allergy Alert Issued for Undeclared Milk, Pine Nuts, and Walnuts in Two Specialty Pesto Products Sold in Whole Foods Market Stores in the North Atlantic Region. All affected products have been removed from store shelves.

June 4
FDA Approved the First Treatment (Emgality (galcanezumab-gnlm solution) for Episodic Cluster Headache That Reduces the Frequency of Attacks. Episodic cluster headache is an extremely painful and often debilitating condition. Cluster headache is a form of headache that produces extreme pain and tends to occur in clusters, often at the same time(s) of the day, for several weeks to months. The headaches are accompanied by symptoms that may include: bloodshot eyes, excessive tearing of the eyes, drooping of the eyelids, runny nose and/or nasal congestion and facial sweating. Cluster headache attacks may strike several times a day, generally lasting between 15 minutes and three hours.

June 3
Deep Foods Inc. Issues Allergy Alert on Undeclared Sulfites In "Deep Golden Raisins"  The recalled "Deep Golden Raisin" were distributed nationwide in retail stores. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.
REGISTRATION IS NOW OPEN!

August 28-29 * 4th Annual Regulatory Workshop
Offices of Buchanan Ingersoll & Rooney * Washington, D.C.

Visit our website to register and for workshop agenda.