As a result of the COVID-19 virus, the 2020 SPA Annual Conference in San Antonio has been cancelled and will be rescheduled for a later date.  We encourage everyone to take the necessary and recommended precautions to help reduce the spread and impact of this virus. Thank you and stay safe.
Specialty Pharma Industry News is provided by SPA Member Dr. Larry Boos
March 31
Guidance for Industry: The U.S. Food and Drug Administration has issued a guidance, "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act."  This guidance is intended to help applicants and manufacturers provide the agency with timely and informative notifications about changes in the production of certain drugs and biological products.
March 30
Coronavirus (COVID-19) Update     The FDA has issued an Emergency Use Authorization (EUA) to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) to be distributed and used for certain hospitalized patients with COVID-19. These drugs will be distributed from the SNS to states for doctors to prescribe to adolescent and adult patients hospitalized with COVID-19, as appropriate, when a clinical trial is not available or feasible.

FDA Issues Updated Guidance on Clinical Trial Conduct During the COVID-19 Pandemic    On March 18, 2020, FDA issued "FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic" to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic.  For the updated guidance, please see:  FDA Guidance on Conduct Trials of Medical Products During COVID-19 Pandemic.

FDA granted approval to durvalumab (IMFINZI, AstraZeneca).    Food and Drug Administration approved durvalumab in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).   For more information Control/Click on  FDA Approves Durvalumab for Extensive-Stage Small Cell Lung Cancer
March 29
FDA Issues New Enforcement Policy for Sterilizers, Disinfectant Devices and Air Purifiers During the COVID-19 Public Health Emergency.    Read the guidance here.
March 28
FDA MedWatch - Chloroquine Phosphate Intended for Fish: FDA Letter to Stakeholders   The FDA's Center for Veterinary Medicine has recently become aware that some consumers may mistake chloroquine phosphate used to treat disease in aquarium fish for FDA-approved drugs (used to treat malaria and certain other conditions in humans) that are being studied as a COVID-19 treatment for humans. Unfortunately, we have learned that one person in the United States has died after he and his wife reportedly took chloroquine used to treat their fish in an attempt to prevent COVID-19; his wife also became very ill.   Do not take any form of chloroquine unless it has been prescribed by a licensed healthcare provider and is obtained through a legitimate source.
March 26
Centers for Disease Control and Prevention:  What to do if you are sick   Download Printer friendly version with Control Click on the colored underlined phrase.

Warning Letters The following companies have received Warning Letters for marketing unapproved products related to Coronavirus Disease (COVID-19):
Gaia's Whole Healing Essentials, LLC
Homeomart Indibuy
Health Mastery Systems DBA Pure Plant Essentials
Vital Silver
Control/Click on the company names above to read its Warning Letter. Products that claim to cure, treat or prevent COVID-19 haven't been evaluated by the U.S. Food and Drug Administration (FDA) for safety and effectiveness and might be dangerous to you and your family. There are currently no vaccines to prevent or drugs to treat COVID-19 approved by the FDA.
March 24
Study suggests new coronavirus may remain on surfaces for days.   Scientists found that SARS-CoV-2 the virus that causes COVID-19   can remain active on plastic and stainless steel surfaces for two to three days under the conditions in this experiment.  It remained infectious for up to 24 hours on cardboard and four hours on copper.  The virus was detectable in aerosols for up to three hours.  These times will vary under real-world conditions, depending on factors including temperature, humidity, ventilation, and the amount of virus deposited.   Although the viruses were able to infect cells in the laboratory, how much virus is likely to cause infections in people remains to be studied.  
March 23
CDER-Small Business & Industry Assistance Generic Drugs Form Webcast April 15-16, 2020
This free two-day virtual Regulatory Education for Industry (REdI) forum offers you the opportunity to interact with FDA subject matter experts from every part of the generic drug review program. To read the agenda and register go to: Regulatory Education for Industry
March 21
The U.S. Food and Drug Administration has issued a final guidance, "Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic."    The guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic, including the current COVID-19 pandemic.  This guidance explains that FDA does not intend to object if, because of pandemic-related high employee absenteeism, firms do not submit certain required adverse event reports to the agency within the timeframes required by statute and regulation, provided that firms submit any delayed reports within six months of restoring the adverse event reporting processes to their pre-pandemic state.

Caring for Someone with COVID-19 at Home   Most people who get sick with COVID-19 will have only mild illness and should recover at home.* Care at home can help stop the spread of COVID-19 and help protect people who are at risk for getting seriously ill from COVID-19.    *Note: Older adults and people of any age with certain serious underlying medical conditions like lung disease, heart disease, or diabetes are at higher risk for developing more serious complications from COVID-19 illness and should seek care as soon as symptoms start.   Go to:  COVID19 - Caring for Someone at Home
March 17
Recall of Active Male by Natural Remedy Store.  Natural Remedy Store is voluntarily recalling all lots of Active Male, 500mg capsules. FDA analysis has found the product to be tainted with undeclared tadalafil.   The presence of tadalafil in this product renders it an unapproved drug for which safety and efficacy has not been established and, therefore, subject to recall.
March 13
Recently Posted Guidance Documents
3/12/2020 - 510(k) Third Party Review Program
3/11/2020 - Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry
3/10/2020 - Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control Guidance for Industry
3/6/2020 - Contact Dermatitis From Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance for Industry
3/6/2020 - Inclusion of Older Adults in Cancer Clinical Trials: Draft Guidance for Industry
3/5/2020 - Safety Testing of Drug Metabolites

Foreign Inspections   The FDA is postponing most foreign inspections through April, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis.   When we are temporarily not able to physically inspect foreign produced FDA-regulated products or manufacturers, as an interim measure we employ additional tools (such as physical examinations and/or product sampling at our borders) to ensure the safety of products imported to the U.S., which have proved effective in the past.   We began exercising this authority when we postponed on-the-ground inspections of manufacturers of FDA-regulated products in China earlier in the outbreak. This is all part of the FDA's multi-pronged and risk-based approach to ensuring quality, as well as compliance, with applicable federal laws and regulations.

Guidance for Industry on Applications for Drugs with Inadequate Generic Competition has been Finalized by the FDA.   This guidance entitled, "Competitive Generic Therapies" (CGTs), which describes the process that generic drug applicants should follow to request designation of a drug as a CGT and the criteria for that designation.    This guidance provides information on actions the FDA may take to expedite development and review of Abbreviated New Drug Applications (ANDAs) for drugs designated as CGTs and explains how the FDA implements the statutory provisions providing for a 180-day exclusivity period for certain first-approved applicants who submit ANDAs for CGTs.
March 12
Safety Alert Regarding Use of Fecal Microbiota for Transplantation (FMT) and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms   The agency is now aware of infections caused by enteropathogenic Escherichia coli (EPEC) and Shigatoxin-producing Escherichia coli (STEC) that have occurred following investigational use of FMT that it suspects are due to transmission of these pathogenic organisms from FMT product supplied by a stool bank company based in the United States.   STEC are pathogenic E. coli that cause painful bloody diarrhea. EPEC is another type of E. coli. Some EPEC strains may cause diarrhea in adults.  Both STEC and EPEC may cause other symptoms, including fever, abdominal pain and vomiting.
March 11
FDA granted accelerated approval to the combination of nivolumab (Opdivo, Bristol-Myers Squibb Co.) and ipilimumab (Yervoy, Bristol-Myers Squibb Co.) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.  For more information Control/Click on: FDA Grants
March 10
The FDA issued the draft guidance Providing Regulatory Submissions in Alternate Electronic Format; Draft Guidance for Industry. This draft guidance provides recommendations on an alternate electronic submission format if a submission is covered under an exemption from or granted a waiver from the requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for the electronic format of the content submitted in new drug applications (NDAs), abbreviated new drug applications (ANDAs), drug master files (DMFs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

Prostate Cancer: Combined Biopsy Strategy Makes for More Accurate Diagnosis    This may be a better approach than using just the traditional 12 needle biopsy tool used to sample the prostate through the rectum.  This technique samples from only one side of the prostate, consequently, it misses small aggressive cancers about 40% of the time.   Now the 12 point biopsy is combined with magnetic resonance imaging (MRI) targeted biopsy during the same session.   Philips Healthcare has created an office-based, outpatient prostate biopsy device, called UroNav, that has been approved by the FDA.   The UroNav system relies on software that overlays MRI images highlighting suspicious areas onto real-time ultrasound images of the prostate that are traditionally used to guide biopsy procedures.  For detailed information watch Video: MRI-Targeted Prostate Biopsy on (YouTube).   Several informative videos will sequence after the first video.
March 6
FDA Approves New Treatment for Adults with Cushing's Disease    The U.S. Food and Drug Administration today approved Isturisa (osilodrostat) oral tablets for adults with Cushing's disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease. Cushing's disease is a rare disease in which the adrenal glands make too much of the cortisol hormone. Isturisa is the first FDA-approved drug to directly address this cortisol overproduction by blocking the enzyme known as 11-beta-hydroxylase and preventing cortisol synthesis.   The disease is most common among adults between the ages of 30 to 50, and it affects women three times more often than men. Cushing's disease can cause significant health issues, such as high blood pressure, obesity, type 2 diabetes, blood clots in the legs and lungs, bone loss and fractures, a weakened immune system and depression. Patients may have thin arms and legs, a round red full face, increased fat around the neck, easy bruising, striae (purple stretch marks) and weak muscles. 
March 5
FDA-TRACK Releases New PDUFA Performance Dashboards   FDA-TRACK releases new performance dashboards for the Prescription Drug User Fee Act (PDUFA). PDUFA authorizes FDA to assess and collect fees for prescription drug products. FDA dedicates these fees toward expediting the drug development process and the process for the review of human drug applications, including post market drug safety activities. These dashboards offer a more concise, interactive, and visual presentation of some of the data reported in FDA's legislatively-mandated annual PDUFA Performance Report to Congress.

Changes that Affect Compounders as of March 23, 2020  A change to the law will impact compounding of certain products beginning on March 23, 2020. On that date, biological products that were approved under the Federal Food, Drug, and Cosmetic (FD&C) Act will transition to being licensed under the Public Health Service (PHS) Act. Beginning on March 23, these transitioning biological products will not be eligible for the exemptions for compounded drugs under sections 503A and 503B of the FD&C Act.  The agency posted a preliminary list of approved biological products that will transition. Outsourcing facilities have recently reported using four bulk drug substances that are affected by the transition: human chorionic gonadotropin, hyaluronidase, follicle stimulating hormone (FSH or urofollitropin) and menotropins. One of these products - hyaluronidase - was on category 1 of the list of substances under our 503B bulks interim policy. As of March 23, this substance will be removed from category 1.   Although these transitioning biological products will not be eligible for the exemptions in sections 503A and 503B, the agency's guidance, Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application, explains the conditions under which we do not intend to take action when certain biological products are mixed, diluted, or repackaged in a manner not described in their approved labeling.   
March 2
Guidance Snapshot Pilot    FDA guidance documents contain the Agency's current best thinking on a particular topic.  Guidance Snapshots are a communication tool that provides highlights from guidance documents using visuals and plain language. This pilot program is intended to increase general public awareness and engagement for FDA guidance documents on innovative topics to support the efficient application of the guidance documents' recommendations.  Guidance Snapshots are not a substitute for the guidance document. Guidance Snapshots should not be used to make drug development decisions.