FDA-Patient Network Newsletter - Wednesday, September 27, 2017

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This bi-weekly newsletter from the FDA Office of Health and Constituent Affair is intended to inform patients, caregivers and patient advocates of FDA-related information including: approvals, labeling changes, safety warnings and other information of interest. Mylotarg for treatment of acute myeloid leukemia On September 1, 2017 FDA approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML).  More information Mammography device with option for patient-assisted compression cleared On September 1, 2017 FDA cleared the first 2D digital mammography system that allows patients to increase or decrease the amount of compression applied to their own breast before the mammogram x-ray is taken. More information FDA permits marketing of mobile medical application for substance use disorder On September 14, 2017 FDA permitted marketing of the first mobile medical application to help treat substance use disorders (SUD). The Reset application is intended to be used with outpatient therapy to treat alcohol, cocaine, marijuana and stimulant SUDs. The application is not intended to be used to treat opioid dependence. More information First biosimilar for the treatment of cancer On September 14, 2017 FDA approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer. More information New treatment for adults with relapsed follicular lymphoma approved On September 14, 2017, FDA granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies. More information First duodenoscope with disposable distal cap cleared On September 20, 2017, FDA cleared the first duodenoscope with a disposable distal cap, a new feature that will improve access for cleaning and reprocessing. The Pentax ED34-i10T model duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems. More information FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease FDA is warning that the liver disease medicine Ocaliva (obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death. These patients are receiving excessive dosing, particularly a higher frequency of dosing than is recommended in the drug label for them. Ocaliva may also be associated with liver injury in some patients with mild disease who are receiving the correct dose. More information FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks Based on our additional review, FDA is advising that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). The combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction can outweigh these risks. More information FDA conducts major global operation to protect consumers from potentially dangerous prescription drugs sold online FDA in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids, antibiotics and injectable epinephrine products to American consumers. More information FDA actions to bring relief to citizens of Puerto Rico; to help the island recover its considerable and economically vital medical product manufacturing base; and to prevent critical shortages of life-saving drugs made in Puerto Rico As an agency dedicated to promoting public health, and as fellow Americans, the staff at the FDA is doing all it can to support the immediate needs of Puerto Ricans following the destruction of Hurricane Maria. More information On a new qualified health claim advising that early introduction of peanuts to certain high-risk infants may reduce risk of peanut allergy As the science governing allergies and diets continues to evolve, so do expert recommendations around how best to safely introduce babies and children to various foods. Perhaps one of the most challenging decisions for parents of my generation is when and how to introduce foods that pose a potential for a significant allergic reaction. More information New efforts to encourage compounding of better quality drugs under DQSA and help health care professionals access compounded medications needed for patient care from outsourcing facilities As a physician, I understand how important it is for health care providers to have access to compounded drugs when the needs of their patients cannot be met by FDA-approved drugs. Our commitment to implementing and enforcing the Drug Quality and Security Act (DQSA) provides a pivotal foundation for achieving these goals. More information Most FDA meetings are free to the public and do not require the public to register.  Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee. Other types of meetings listed may require prior registration and fees. View FDA Patient Network Calendar of FDA Sponsored Public Meetings for a list of meetings and workshops that may be of interest to patients and caregivers. FDA rules have great impact on the nation's health, these rules are formed with the public's help. By law, anyone can participate in the rule-making process by commenting in writing.  View FDA Patient Network  Opportunity to Comment on Current Draft Guidance page, for a list of current draft guidances and other topics of interest for patients and caregivers. Drug Discontinuation Voluntarily Reported by Manufacturers During the Past 4 Weeks: Triamcinolone Acetonide Cream Olanzapine and Fluoxetine (Symbyax) Capsules Montelukast Sodium Chewable Tablet Testosterone (Axiron) Solution Drug Shortages Voluntarily Reported by Manufacturers During the Past 4 Weeks: Aminocaproic Acid Injection, USP Diazepam Injection, USP FDA knows the major public health consequences that can result from drug shortages. These shortages occur for many reasons including manufacturing and quality problems, delays and discontinuations. When issues are discovered, FDA works closely with the company to address risks involved to prevent harm to patients. FDA also considers the impact a shortage would have on patient care and access and works with the company to restore supplies while also ensuring safety for patients.  More information on drug shortages and discontinuations: Drug Shortage Database and Vaccines, Blood and Biologic Shortages Criminal and civil actions filed against Aegerion Pharmaceuticals Inc. On September 22, 2017, Aegerion Pharmaceuticals Inc. agreed to plead guilty in the United States District Court for the District of Massachusetts to two misdemeanor counts of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) involving the introduction of misbranded Juxtapid (lomitapide) into interstate commerce. More information Federal judge orders Flawless Beauty to stop distributing unapproved drugs, recall certain products A federal judge ordered a New Jersey company that sold injectable skin whitening and other beauty products to stop selling and recall some of its products because they are unapproved new drugs that may be unsafe, putting consumers at risk. More information Information about Expanded access Expanded access also called "compassionate use," is the use of an investigational medical products outside of a clinical trial (i.e., one that has not been approved by FDA). FDA is committed to increasing awareness of and knowledge about its expanded access programs and the procedures for obtaining access to human investigational drugs (including biologics) and medical devices. More information FDA selects participants for new digital health software precertification pilot program FDA announced the names of the companies selected to participate in a first-of-its kind pilot program that will help revolutionize digital health regulation in the U.S. More information The FDA Encourages New Treatments for Sickle Cell Disease Sickle cell disease (SCD) is the most common inherited blood disorder in the United States. It affects about 100,000 children and adults in the United States and millions of people worldwide. New treatments are needed to prevent and treat its serious complications. That's why the U.S. Food and Drug Administration is working with patients and stakeholders, including academics and those from the pharmaceutical industry, to help. More information What to Expect With the Next Compliance Dates for the FSMA Preventive Controls for Animal Foods Rule The second major compliance dates will soon arrive for the preventive controls for animal food rule under the FDA Food Safety Modernization Act (FSMA). On September 18, 2017, larger animal food facilities must comply with preventive controls requirements mandated by FSMA. These facilities had to meet Current Good Manufacturing Practice (CGMP) requirements by September 2016. More information CTP's Enduring Priority: Protecting Kids CTP is committed to protecting today's kids and future generations from the dangers of tobacco  use. Findings from recent studies, including the 2016 "National Youth Tobacco Survey" (NYTS), provide some encouraging signs about the declining use of certain types of tobacco products by youth and about the effectiveness of CTP's efforts aimed at safeguarding youth from the harms of tobacco use.  Read more about NYTS and steps the FDA is taking to keep tobacco products out of the hands of youth. Heat-Not-Burn Device Under FDA Review for Modified Risk Three modified risk tobacco product (MRTP) applications submitted by Philip Morris Products S.A. for its IQOS system and various Heatstick products are under scientific review by CTP, and public comments may be submitted either online or in hard copy by Dec. 12. The applications can be viewed on CTP's website, and public comments may be submitted online to docket FDA-2017-D-3001 on regulations.gov.  The public nature of the MRTP application process is unique. By law, the FDA must make MRTP applications available for public comment, while ensuring commercial and confidential information is properly redacted. In its scientific review of an MRTP application, the FDA considers public comments, as well as recommendations from the Tobacco Products Scientific Advisory Committee. Read the Full Article. Missed the last issue of CTPConnect? The Center also publishes a regular periodical known as CTPConnect, a plainspoken digest with the latest stories from the Center. The FDA Patient Network Newsletter is provided to you by the FDA Office of Health and Constituent Affairs. If you have questions about the newsletter, email us at PatientNetwork@FDA.HHS.GOV

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