Specialty Pharma Industry News is provided by SPA Member Dr. Larry Boos
August 31
FDA is Switching to a New Free Email Subscription Service, GovDelivery  The U.S. Food and Drug Administration (FDA) is pleased to announce that we will be using GovDelivery to send our free email updates. We have made a few improvements to our email subscription service.  You will be able to:  1) Customize your emails based upon your particular areas of interest. You may subscribe to one, several, or as many of the topics as you wish.  2) Choose a frequency preference for how often you would like to receive email.  3) Unsubscribe from any topic at any time, and 4) Change your email address or remove yourself at any time.  Click on Manage Subscriptions to access your subscription preferences using GovDelivery.

Hand Sanitizers Packaged in Food and Drink Containers   The U.S. Food and Drug Administration (FDA) is warning consumers about alcohol-based hand sanitizers that are being packaged in containers that may appear as food or drinks and may put consumers at risk of serious injury or death if ingested. The agency has discovered that some hand sanitizers are being packaged in beer cans, children's food pouches, water bottles, juice bottles and vodka bottles. Additionally, the FDA has found hand sanitizers that contain food flavors, such as chocolate or raspberry.
August 28
FDA's CDER Small Business and Industry Assistance (SBIA) is making available our YouTube learning library - now hundreds of our recordings are readily accessible.   Bookmark and share 2020 External Link Disclaimer, 2019 External Link Disclaimer, 2018 External Link Disclaimer, and 2017 External Link Disclaimer recordings of webinar and conference presentations. New content will be posted on  SBIAs LinkedIn page External Link Disclaimer, and top viewed presentations will be updated quarterly. The subject matter expert presentations are intended to educate and help industry navigate FDA policies and procedures.   For more information go to to the website here.
August 27
FREE FDA CDER SBIA Workshop | Learn about Complex Products and Innovative Science in     Generic Drugs| Webcast Registration Now Open | Sep. 29-30, 2020.   Topics include 1) Method Development / Validations for Non-traditional Analytical Methods, 2) Excipient and Formulation Considerations,  3)  Future Directions, Emerging Technology, and Current Thinking on Alternative Bioequivalence (BE) Approaches,  4)  Practical Considerations in the Study Design and Data Evaluation Recommended in Product-Specific Guidances (PSGs).     To register for this event go to the SBIA site here.

Warning Letters
Kalchem International, Inc.; Kalyn Tabor, President; Lindsay, OK 73052
1) Your firm shipped an over-the-counter (OTC) drug product three days before you received the certificate of analysis (COA) with assay results from your contract laboratory for the active ingredient
2) It is common practice for your firm to relabel and distribute lots without a written procedure and documentation.
3) Your active pharmaceutical ingredient (API) labels falsely represent that Kalchem is the sole drug manufacturer; consequently, your APIs are misbranded.
4) Several of your products that are being introduced into interstate commerce have labeling claims on the labels that cause those products to be misbranded
5) You have failed to correct previous FDA observations at your facility. Failure to promptly correct these past and current violations and deviations may result in legal action without further notice including, without limitation, seizure and injunction.

Sprout Pharmaceuticals, Inc.; Cindy Eckert, CEO; Raleigh, NC 27609
The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed a direct-to-consumer (DTC) radio advertisement (radio ad) (US-1900289.03) for ADDYI (flibanserin) tablets, for oral use (Addyi) submitted by Sprout Pharmaceuticals (Sprout) under cover of Form FDA 2253. This radio ad makes false or misleading claims about the risks associated with Addyi and omits other material facts. Thus, the radio ad misbrands Addyi within the meaning of the FD&C Act.

Mayon's Pharmaceuticals Pvt Ltd; Yusuf Chimthanawala, Nagpur 440002 Maharashtra, India
1. Your firm failed to test incoming components used to manufacture your in-process homeopathic materials and finished homeopathic drug products to determine identity, purity, strength, and quality.
2. You released numerous batches of drugs, some of which contain ingredients with toxic components, without validating your manufacturing process.
3. Our investigator observed dead legs, dripping, and threaded piping in your pharmaceutical system used for the formulation of some of your homeopathic drug products. These defects are not allowed in a pharmaceutical system.
4. You failed to clean equipment and utensils to prevent contamination or carryover of a material that would alter the quality of the active pharmaceutical ingredients (APIs) beyond the official or other established specifications.
5. You failed to establish adequate written procedures for cleaning equipment and its release for use in the manufacture of APIs.

The following companies have received warning letters for unlawful sale of unapproved and misbranded opioids to United States consumers over the Internet
Thomas Meds, IceNetworks Ltd., www.buydrugsmedsonline.com, www.usphramacyshop.com, greenrxpharmacy.com, lekapharma.com, genericpharmacyusa.com, www.rxeasymeds.com, www.roidsforce.com , www.skylimitpharmacy.com, Klasiekpharmacy.com, www.xsterids.com , besteroidstore.net, melanopharmacy.com, bluepillmedications.com, globalpharmacystores.com, and alpharoyalpharmacy.com

August 26
FDA Publishes New Manual of Policies and Procedures (MAPP), Transfer of Drug Application  Ownership (MAPP 5242.1)   "Transfer of Ownership." This MAPP details how staff in the Office of Generic Drugs (OGD) will process the requests submitted by former and new owners of drug applications to transfer drug application ownership as listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book").    For full details, please view the MAPP here.
August 25
Is your hand sanitizer on the FDA's list of products you should not use?   Before you buy hand sanitizer or use hand sanitizer you have at home, the FDA recommends checking our do-not-use list at www.fda.gov/handsanitizerlist. FDA quality testing uncovered toxic ingredients in some hand sanitizers.
August 21
Recently Posted Guidance Documents
8/19/2020 - Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers: Guidance for Industry
8/18/2020 - Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) : Guidance for Industry

Recall:  Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 750 mg by Bayshore Pharmaceuticals Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity.  NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.
August 20
FDA Approves Label Changes to Hydrochlorothiazide to describe risk of non-melanoma skin cancer.  The U.S. Food and Drug Administration has approved changes to the hydrochlorothiazide (HCTZ) drug label to inform health care professionals and patients about a small increased risk of non-melanoma skin cancer (basal cell skin cancer or squamous cell skin cancer) associated with HCTZ use and to encourage patients to protect their skin from the sun. Hydrochlorothiazide is a diuretic used to treat high blood pressure and other conditions.   The overall risk for non-melanoma skin cancer increases as individuals age and as they spend more time in the sun. The increased risk of developing non-melanoma skin cancer while taking HCTZ, a drug associated with photosensitivity (increased sensitivity to sunlight), is small.  An FDA Sentinel Initiative study found that the increased risk was mostly for squamous cell carcinoma (SCC).   Patients who decide to continue to use HCTZ should take protective skin care measures to reduce their risk of non-melanoma skin cancer.
August 18
FDA published the guidance for industry entitled "Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)."   This guidance describes FDA's compliance policy related to the retention of reserve samples of the test article and reference standard used in an in vivo bioavailability (BA) and in vivo or in vitro bioequivalence (BE) study. This guidance applies only to the requirements for retention of reserve samples contained in 21 CFR 320.38(c).
August 14
FY 2021 PDUFA Program Fee Invoices and FY 2021 PDUFA Fee Rates The fiscal year (FY) 2021 PDUFA program fee invoices were emailed on Friday, August 14, 2020. If you do not receive your invoice by August 14, and believe you should receive a program fee invoice, please contact PDUFA User Fee staff at CDERCollections@fda.hhs.gov

User Fee Type                                                    FY 2020           FY 2021 
Application Fee - Clinical Data Required          $2,942,965       $2,875,842 
Application Fee - No Clinical Data Required    $1,471,483        $1,437,921 
Program Fee                                                        $325,424          $336,432
August 10
FDA published the guidance for industry, Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format.   This Section 506I imposes additional reporting requirements on new drug application (NDA) and abbreviated new drug application (ANDA) holders regarding the marketing status of approved products. Download your copy by Control/Click on the colored title above.
August 5
FDA finalizes guidance, "Limited Population Pathway for Antibacterial and Antifungal Drugs."
The final guidance will aid in the development of certain new antibacterial and antifungal drugs by describing criteria, processes, and other general considerations required of drugs approved under the limited population pathway for antibacterial and antifungal drugs (LPAD pathway). Control/Click on the colored title above to download your copy.