SPA 2019 Pharma Conference
April 3-5, 2019
December 2018
Specialty Pharma Industry News is provided by SPA Member Dr. Larry Boos
November 27
FDA alerts health care professionals and patients not to use sterile drug products from Pharm D Solutions.    FDA issued a  warningletter  
to Pharm D in December 2016 following an inspection. During FDA's recent follow-up inspection of Pharm D's compounding facility in August 2018, investigators observed insanitary conditions, including poor sterile production practices and deficient environmental monitoring. These conditions raised concerns about the company's ability to assure the sterility of its drug products. Pharm D resumed sterile operations on October 8, 2018, and distributed purportedly sterile products without making adequate corrections at the facility. Pharm D agreed to cease sterile operations again on November 9, 2018, but has not agreed to FDA's recommendation to recall all unexpired drug products intended to be sterile. These compounded drug products could put patients at risk.
November 19
FDA Completes Review of Qualified Health Claim Petition for Oleic Acid and the Risk of Coronary Heart Disease.  The U.S. Food and Drug Administration (FDA) has determined that there is credible evidence to support a qualified health claim that consuming oleic acid in edible oils, such as olive oil, sunflower oil, or canola oil, may reduce the risk of coronary heart disease.  Oleic acid is a monounsaturated fat which, when substituted for fats and oils higher in saturated fat, may reduce the risk of coronary heart disease.  "Supportive but not conclusive scientific evidence suggests that daily consumption of about 1½ tablespoons (20 grams) of oils containing high levels of oleic acid, when replaced for fats and oils higher in saturated fat, may reduce the risk of coronary heart disease."

The Quaker Oats Company Issues Voluntary Recall of a Small Quantity of Cap'n Crunch's Peanut Butter Crunch Cereal Distributed to Five Target Stores Due to Possible Health Risk. Quaker is initiating the voluntary recall to protect public health due to the potential presence of Salmonella.  Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
November 16
FDA approves new treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli.  The U.S. Food and Drug Administration today approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers' diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool. The most common adverse reactions with Aemcolo were headache and constipation.   Travelers' diarrhea is defined by having three or more unformed stools in 24 hours, in a person who is traveling. It is caused by a variety of pathogens, but most commonly bacteria found in food and water. The highest-risk destinations are in most of Asia as well as the Middle East, Africa, Mexico, and Central and South America.

FDA Reminds Parents Not to Feed Honey to Children Younger Than 1 Year: Honey Pacifiers Suspected in Texas Infant Botulism Cases.  The FDA has received reports from the state of Texas that four infants have been hospitalized with botulism. All four infants had used pacifiers containing honey. These pacifiers were purchased in Mexico, but similar products also appear to be available in the U.S. through online retailers.

FDA approves new first-line treatment for peripheral T-cell lymphoma under a new review pilot.  The U.S. Food and Drug Administration expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.  PTCLs are rare, fast-growing non-Hodgkin lymphomas that develop from white blood cells called T-cells. The T-cells often spread quickly throughout the body and are hard to treat.
November 15
FDA Intends to Extend Comment Period on Use of the Names of Dairy Foods in Labeling Plant-Based Products.  The U.S. Food and Drug Administration is announcing its intention to extend by 60 days the comment period on the request for information on labeling plant-based products with names that include the names of dairy foods, such as "milk," "yogurt," and "cheese." The original comment period was scheduled to end on November 27.  To submit electronic comments, go to to Docket Folder FDA-2018-N-3522.
November 14
CDER SIBA Webinar:  Final Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations, Thursday December 6, 2018, 1:00 PM - 2:00 PM EDT.  View Agenda and Register Here

Warning Letters
Grand Rapids E-Liquid, Grand Rapids, MI 49525
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website and determined that the e-liquid products listed there are offered for sale to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including e-liquid, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a (b)). FDA has determined that your Neapolitan Ice Cream e-liquid is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold this product to a person younger than 18 years of age.
November 13
FDA releases draft guidance for industry entitled "Nonmetastatic, Castration-Resistant Prostate Cancer:  Considerations for Metastasis-Free Survival Endpoint in Clinical Trials."  Additional information is available in the Federal Register Notice.

Guidance for Industry  Hypertension: Developing Fixed-Dose Combination Drugs for Treatment Guidance for Industry    Download with control/click on the colored title above.

FDA will hold a  public meeting  entitled "Drug Development Tool Process under the 21st Century Cures Act and Prescription Drug User Fee Act VI." 
This meeting will provide an opportunity for public input regarding the drug development tools qualification pathway for animal models, biomarkers, and clinical outcome assessments.  The FDA is holding this public meeting to discuss taxonomy for biomarkers and related concepts used in drug development, and planning activities to define a framework with appropriate standards and scientific approaches to support qualification for a specified context of use.  In addition to providing input at the public meeting, stakeholders are invited to submit comments through the  public docket . Electronic or written comments can be submitted to the docket through January 31, 2019. 

November 9
FDA highlights record-breaking number of generic drug approvals in October.   The U.S. Food and Drug Administration is providing a summary of the  generic drug approval actions  for the month of October 2018 as part of its efforts to improve patient access to high-quality, lower cost, safe and effective medicines.  In October, the FDA approved 110 generic drugs and tentatively approved 18 generic drugs, for a total of 128 approval actions. This included 23  first generics  for brands that lacked competition and 17 complex generics.

FDA approves new drug for maintenance treatment of adult patients with chronic obstructive pulmonary disease (COPD ).  Today, the U.S. Food and Drug Administration (FDA) approved Yupelri (revefenacin) Inhalation Solution for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Revefenacin is a long-acting muscarinic antagonist (LAMA), which is a class of medicines that improve lung function in patients with COPD. Revefenacin is an inhalation solution that is administered once daily via a standard jet nebulizer.  For more information, please visit: Yupelri (revefenacin) Inhalation Solution.  

FDA updates on angiotensin II receptor blocker (ARB) recalls: Sandoz's losartan potassium and hydrochlorothiazide nationwide recall of one lot due to NDEA.    Losartan, is an angiotensin II receptor blocker (ARB), and hydrochlorothiazide, a diuretic, used in combination for the treatment of hypertension.   Sandoz's product was made using an active pharmaceutical ingredient (API) that has tested positive for NDEA. The API was manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd, which is on import alert.  FDA continues to investigate the presence of NDEA and NDMA, which are probable human carcinogens, in ARBs and is taking swift action when it identifies unacceptable impurities in API and finished drug products.
November 8
The Food and Drug Administration is alerting consumers about a voluntary recall of all lots of Puriton Eye Relief Drops, 0.5 oz. (15 ml) bottle
These products are labeled as a homeopathic and are being recalled due to non-sterile production conditions at the manufacturing facility. Consumers should stop using this product and contact their physician or health care provider if they experience any problems that may be related to using this product.  Use of a non-sterile eye drop product is potentially vision-threatening due to the risk of an eye infection. Additionally, the pH of this product is relatively high and can cause direct destruction of tissues in the cornea, anterior chamber and deeper structures of the eye, which can lead to scarring, glaucoma or vision loss.

A new version  Primatene Mist (epinephrine) metered-dose inhaler has been approved for Over-the-Counter use to provide temporary relief for symptoms of mild, intermittent asthma. 
This OTC drug is approved only for those who have been diagnosed with asthma by a health care provider.   Asthma is a serious health condition that requires careful assessment and ongoing follow-up with a health care professional. It's important for us to note that Primatene Mist is not a replacement for prescription asthma treatments. Patients with asthma should be under the care of a health care professional.
November 6
November 5
CDER SBIA Chronicles:  FDA Facilitates the Use of Surrogate Endpoint in Drug DevelopmentDownload your copy by Control/Click on:     Download (PDF - 181KB)

FDA Finalizes Guidance on Mandatory Recall Authority.  
The U.S. Food and Drug Administration has released a 
final guidance  regarding the agency's mandatory recall authority under the FDA Food Safety Modernization Act (FSMA).   The 2011 food safety law gave FDA mandatory recall authority for foods if there is a reasonable probability that the food is adulterated or misbranded under certain FDA authorities, and that the food could cause serious illnesses or death. FDA must give the responsible party an opportunity to conduct a voluntary recall before ordering a mandatory recall. Prior to the enactment of FSMA, FDA could only rely on manufacturers to voluntarily recall certain potentially harmful food products.  This final guidance follows a draft which was made available for public comment in 2015, and provides additional clarity including some modifications based on comments received.  
FDA has issued a mandatory recall order of a food product only once. In April 2018, FDA issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several products were found to contain Salmonella. 
November 2
FDA alerts patients and health care professionals that some EpiPen (epinephrine) auto-injectors may not readily slide out of carrier tube.    FDA is alerting patients, caregivers and health care professionals that the labels attached to some EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, and the authorized generic versions, may block access to the auto-injector and prevent the ability to easily access the product.  In a  letter  to health care professionals from Pfizer, the manufacturer of the Mylan EpiPen, the label sticker on the auto-injector unit may have been improperly applied, causing resistance when removing it from the carrier tube. The carrier tube is the immediate package in which the auto-injector is contained. In some cases, the patient or caregiver may not be able to quickly remove the epinephrine auto-injector from the carrier tube.  It is vital for lifesaving products to work as designed in an emergency situation, and patients and caregivers should inspect their epinephrine auto-injector prior to needing it to ensure they can quickly access the product.

FDA approved Udenyca (pegfilgrastim-cbqv), a biosimilar to Neulasta (pegfilgrastim). 
A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must be shown to have no clinically meaningful differences in terms of safety and effectiveness from the reference product. For more information about biosimilar products, visit

Electronic Submission of approved ANDAs is now available through CDER Direct NextGen Collaboration Portal.   As of October 1, 2018, generic drug applicants and their affiliates, or an authorized representative, can submit a list of their approved ANDAs to the FDA for the remainder of GDUFA II (2020-2022), through the CDER Direct NextGen Collaboration Portal. Submissions are due by April 1 of the year prior to the fiscal year they reflect. For example, submissions for FY2020 are due by April 1, 2019. Submitting this information electronically will streamline the process and facilitate two-way communication between applicants and the Office of Management at the FDA.  To submit your list of approved ANDAs for fiscal years 2020-2022, you must first register for a CDER Direct NextGen Collaboration Portal account at   For more information, including general questions, or to request a login, login instructions, and contact information, visit the  CDER Direct NextGen Collaboration Portal FAQs .

FDA Issues Two Guidances on Nutrition Facts Label Issues.
The U.S. Food and Drug Administration today issued one draft and one final guidance on various topics related to the two final rules updating the Nutrition Facts label.  The first guidance, which is draft, "
  • the definition of a single-serving container,
  • reference amounts customarily consumed, which are used by companies to determine serving size,
  • dual-column labeling, and
  • miscellaneous issues, such as requirements relating to chewing gum and to multi-unit retail food packages.
The second guidance, which is final, is " Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals: Guidance for Industry." The majority of the guidance consists of questions and answers to help manufacturers determine how to calculate "added sugars" in their products under certain circumstances. Other topics include compliance, label formats, and the declaration of quantitative amounts of vitamins and minerals.  The guidances are meant to provide clarity to food manufacturers to help them comply with the FDA's updated labeling regulations, which are required by January 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales will have an additional year to comply.   To ensure that comments on the draft guidance are reviewed before work begins on the final guidance, please submit them either electronically or in writing within 60 days of the date of the draft guidance's publication in the Federal Register. 

Submit electronic comments to the Federal eRulemaking Portal: Written comments can be submitted to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 .
November 1
FDA Warns Against the use of Many Genetic Tests with Unapproved Claims to Predict Patient Response to Specific Medications.    The FDA has become aware of genetic tests with claims to predict how a person will respond to specific medications in cases where the relationship between genetic (DNA) variations and the medication's effects has not been determined. These genetic tests might be offered through health care providers or advertised directly to consumers and claim to provide information on how a patient will respond to medications used to treat conditions such as, depression, heart conditions, acid reflux, and others. They might claim to predict which medication should be used or that a specific medication may be less effective or have an increased chance of side effects compared to other medications due to genetic variations.   There are a limited number of cases for which at least some evidence does exist to support a correlation between a genetic variant and drug levels within the body, and this is described in the labeling of FDA cleared or approved genetic tests and FDA approved medications. The FDA authorized labels for these medical products may provide general information on how DNA variations may impact the levels of a medication in a person's body, or they may describe how genetic information can be used in determining therapeutic treatment, depending on the available evidence.    Recommendations for Patients:  Be aware that most genetic tests that make claims about the effects of a specific medicine are not supported by enough scientific information or clinical evidence.  Do not change or stop taking any medicine based on a report from a genetic test you took on your own and discuss the results with your healthcare provider.