Specialty Pharma Industry News is provided by SPA Member Dr. Larry Boos
May 29
Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19   There's a lot of confusion about which medical products might work to prevent or treat coronavirus disease 2019 (COVID-19). Scientists are working hard to develop a number of potential drugs for the prevention or treatment of coronavirus, but none are currently approved by the FDA for these purposes.   The language used to describe potential therapies can be confusing, and this article discusses what you need to know about the terms used to describe COVID-19 research. Article Link

Apotex Corp. Issues Voluntary Nationwide Recall of all lots of Metformin Hydrochloride Extended-Release Tablets 500mg Due to the Detection of N-nitrosodimethylamine (NDMA)    One lot of Metformin Hydrochloride Extended-Release Tablets, USP was tested and showed results for N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI).    NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

FDA Takes Action to Enhance Utility of the Orange Book (aka "Approved Drug Products with Therapeutic Equivalence Evaluations").   The FDA is providing draft guidance (available at a Federal Register notice ) and seeking feedback from a wide range stakeholders and the public to help consider how the FDA can enhance this resource.  Go to the Federal Register Notice (Control/Click on the colored letters above) to open a docket for your submission of public comments on use of the Orange Book.  The comment period ends on August 31, 2020, but the guidance states that comments are to be submitted by July 27, 2020.
May 28
The FDA has approved Tauvid (fiortaucipir F18) for intravenous injection to help image using positron emission tomography (PET) a distinctive characteristic of Alzheimer's disease in the brain called tau pathology.  Two proteins - tau and amyloid - are recognized as hallmarks of Alzheimer's disease. In patients with Alzheimer's disease, pathological forms of tau proteins develop inside neurons in the brain, creating neurofibrillary tangles. After Tauvid is administered intravenously, it binds to sites in the brain associated with this tau protein misfolding. The brain can then be imaged with a PET scan to help identify the presence of tau pathology.

Webinar: Still submitting paper to CDER? Send electronically with CDER's NextGen Portal instead! (for submissions not required in eCTD) INTENDED AUDIENCE:
* Research IND Sponsors planning to submit in paper to CDER
* Type III Drug Master File Holders planning to submit in paper to CDER
* Sponsors and Applicant Holders who received an eCTD waiver for their NDA, BLA, ANDA, DMF, or Commercial IND and planning to submit in paper to CDER
* Regulatory affairs professionals submitting marketing and advertising materials in paper to CDER
* Medical Gas applicants planning to submit in paper to CDER
To watch webinar now click this link.
May 26
Draft Guidance for Industry:     Q3C(R8) Recommendations for the Permitted Daily Exposures for Three Solvents-2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tert-Butyl Alcohol-According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents

Download the Draft Guidance Document
Read the Federal Register Notice

Acella Pharmaceuticals, LLC Issued a Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Super Potency.
Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® (thyroid tablets, USP) to the consumer level. The products are being recalled because our testing has found these lots to be superpotent. The product may have up to 115.0% of the labeled amount of Liothyronine (T3).
Patients being treated for hypothyroidism (underactive thyroid), who receive superpotent NP Thyroid, may experience signs and symptoms of hyperthyroidism (overactive thyroid) which include, but are not limited to, weight loss, heat intolerance, fatigue, muscle weakness, hypertension, chest pain, rapid heart rate, or heart rhythm disturbances.

FDA opens registration for virtual public meeting on reauthorizing the Prescription Drug User Fee Act (PDUFA)    On July 23, 2020, the U.S. Food and Drug Administration (FDA) will hold a virtual public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act for fiscal years 2023 through 2027 ("PDUFA VII").  PDUFA authorizes the FDA to collect user fees which supports the process for the review of human drugs and creates a reliable funding source that is important to the Agency's continued ability to ensure timely review of the safety and effectiveness of new medications. FDA's current PDUFA authorization ("PDUFA VI") expires in September 2022.    The purpose of this virtual public meeting is to allow interested stakeholders an opportunity to provide their views on the program's reauthorization as FDA considers which, if any, features to propose, update, or discontinue in the next PDUFA.  To attend this meeting, please register by June 23, 2020. Registrants will receive instructions to access the live webcast of the virtual meeting. 

FDA Approves Brigatinib (ALUNBRIG, by ARIAD Pharmaceucticals, Inc.)    This drug is intended for adult patients with anaplastic lymphoma kinase (ALK)-positive metastic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. For more information Control/Click here.
May 22
Policy Updates to FDA Guidances on Compounding Certain Drugs for Hospitalized COVID-19 Patients   The guidance for temporary compounding of certain drugs by outsourcing facilities during the COVID-19 public health emergency has been updated to include timely product reporting by outsourcing facilities compounding drugs covered by the guidance.   The guidance for temporary compounding of certain drugs by pharmacy compounders during the COVID-19 public health emergency has been updated to include pharmacy compounder reporting to FDA on adverse events associated with drugs compounded under this guidance.   Hospitals that cannot obtain FDA-approved drugs and seek to use compounded drugs for their hospitalized patients should first contact outsourcing facilities that produce compounded drugs under more robust quality standards than those made by state-licensed pharmacies or federal facilities.
May 21
Biota Biosciences Issues Voluntary Nationwide Recall of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables Because They Were Marketed Without FDA Approval.   The products claims on our website make these products unapproved new drugs. Further, the products are misbranded because the labeling fails to bear adequate directions for use.   Unapproved new drugs injected into the bloodstream for which safety and efficacy have not been established could pose a serious risk of harm to users because they bypass many of the body's natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. 
May 20
FDA has updated a final guidance, "Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic," to include information for compounded drugs (see table 1 in the guidance). The guidance provides recommendations to industry regarding adverse event reporting for products during a pandemic.   Please see our website for more FDA guidance related to COVID-19. Please contact compounding@fda.hhs.gov with questions.

FDA is Gradually Restarting Its Surveillance Inspections.  Since March due to COVID-19 only mission-critical inspections abroad and domestic for cause inspections have been carried out.  During this time they have implemented an alternative approach to on-site surveillance inspections.  If no on-site inspection was to be conducted at a company, then it received an FDA Pre-Inspection Records Request which included an FDA Form 4003 to be completed and returned to the FDA in two weeks (10 business days).  Companies receiving the FDA Form 4003 were told that failure to submit the requested records by the date requested may cause their products to be adultrated within the meaning of section 501(j) of the Federal Food, Drug, and Cosmetic Act. 

FDA approved olaparib (LYNPARZA, AstraZeneca Pharmaceuticals, LP) for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC), who have progressed following prior treatment with enzalutamide or abiraterone.  For more information go to this link.

Webinar (Free) - CDER SEND Common Issues and Policy Update Monday, June 15, 2020,| 1:00 p.m. - 2:30 p.m. Eastern Intended Audience:
* Regulatory affairs professionals who submit SEND data to FDA for review
 CROs and/or consultants preparing and reviewing SEND datasets for Sponsors
 Staff of Standards Developing Organizations responsible for Implementation Guides for use by the Pharmaceutical Industries
To register for this event go t this link.
May 12
MasterPharm, LLC. Issues Voluntary Nationwide Recall of Finasteride Plus 1.25mg Due to the Presence of an Undeclared Antihypertensive Drug.   The Finasteride Plus capsules have been found to contain undeclared minoxidil, an antihypertensive drug, at levels greater than those found in FDA approved products. The undeclared minoxidil was found when tested with an independent testing laboratory.  Consumption of undeclared minoxidil would be expected to result in low blood pressure, rapid heartbeat, and salt and water retention causing swelling. Consequently, patients may be at risk for developing heart failure or other heart damage. Excess fluid between the heart and the sac surrounding the heart has also been reported in association with minoxidil use. MasterPharm, LLC has received 33 reports of increased heart rate, retention of water, dizziness and low blood pressure.
May 6
Food and Drug Administration granted accelerated approval to capmatinib (TABRECTA, Novartis) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. Read article here.
May 3
Guidance for Industry 4/30/2020 - Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency: Guidance for Industry