Specialty Pharma Industry News is provided by SPA Member Dr. Larry Boos
September 30
FDA and DEA warn website operators illegally selling opioids.  The U.S. Food and Drug Administration and the U.S. Drug Enforcement Administration have issued joint warning letters to four online networks, operating a total of 10 websites, illegally marketing unapproved and misbranded versions of opioid medicines, including tramadol, that are potentially dangerous. The networks receiving warning letters include: Divyata, Euphoria Healthcare Pvt Ltd., JCM Dropship, and Meds4U.  These companies have 15 days to respond or be subject to legal enforcement action.
September 27
Zantac - Ranitidine Tablets, 75 mg and 150 mg by Apotex: Recall - Due to the Potential for Detection of an Amount of Unexpected Impurity, N-nitrosodimethylamine (NDMA) Impurity in the Product.  NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.   In addition, 14 lots of ranitidine 150 mg and 200 mg capsules distributed by Sandoz are also being recalled for the same reason.   Ranitidine is an over-the-counter (OTC) and prescription drug.  Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. OTC ranitidine is approved to prevent and relieve heartburn associated with acid ingestion and sour stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.  
September 26
FDA approves daratumumab for transplant-eligible multiple myeloma.  FDA approved daratumumab (DARZALEX, Janssen) for adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant (ASCT).   For more information go to:  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-transplant-eligible-multiple-myeloma .

FDA Grand Rounds will discuss why the IQOS heated tobacco product marketing was authorized as "Appropriate for the protection of the public health."  To be held on Thursday, October 10, 2019, 12:00 p.m. - 1:00 p.m. EST.  Register here for webcast (public attendees and FDA staff)
September 25
The FDA has issued a draft guidance, Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act. This guidance discusses submission types that will be required to be submitted solely in electronic format as required by section 745A (b) of the Federal Food, Drug, and Cosmetic Act. Download the guidance by Control/Click on the blue letters in the title.
September 24
FDA Celebrates the 25th Anniversary of the Hatch-Waxman Amendments. Today marks the 35th anniversary of the "Drug Price Competition and Patent Term Restoration Act of 1984," commonly referred to as the Hatch-Waxman Amendments. These amendments established the modern-day approval pathway for generic drug products, among other things.  When the Hatch-Waxman Amendments were enacted in 1984, generic drugs accounted for only 19% of all prescription drug purchases in the United States. That number is now more than 90% due to the policies advanced under the Hatch-Waxman Amendments and the Generic Drug User Fee Amendments (GDUFA).

The U.S. Food and Drug Administration announced today the approval of Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating, for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. This is the only currently FDA-approved vaccine for the prevention of monkeypox disease.  Routine vaccination of the American public was stopped in 1972 after the disease was eradicated in the U.S. and, as a result, a large proportion of the U.S., as well as the global population has no immunity. Jynneos does not contain the viruses that cause smallpox or monkeypox. It is made from a vaccinia virus, a virus that is closely related to, but less harmful than, variola or monkeypox viruses and can protect against both of these diseases. Jynneos contains a modified form of the vaccinia virus called Modified Vaccinia Ankara, which does not cause disease in humans and is non-replicating, meaning it cannot reproduce in human cells.
September 23
FDA issues guidance for industry on wholesale distributor verification requirement for saleable returned drug product.  FDA announced the availability of a final guidance for industry entitled "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product--Compliance Policy." This guidance announces FDA's compliance policy regarding the Drug Supply Chain Security Act (DSCSA) provision requiring wholesale distributors to verify a product identifier prior to further distributing returned drug products. Given concerns expressed by stakeholders, and to minimize possible disruptions in the pharmaceutical distribution supply chain, FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2020, verify a product identifier prior to further distributing returned product as required under the DSCSA.  This represents a one-year delay in enforcement of this DSCSA requirement. This compliance policy does not extend to the other requirements that will take effect on November 27, 2019. 

FDA encourages patient engagement activities in clinical trials through release of a draft guidance entitled,  Patient Engagement in Design and Conduct of Medical Device Clinical Investigations.  Providing patients and their family caregivers the opportunity to provide their insights about a disease or condition, including living with that disease or condition as well as the impact of medical devices in the diagnosis, treatment, and management of their disease or condition, can inform and improve the clinical trial process. As a result, these patient engagement activities can help medical device developers obtain experience, perspectives, and other relevant information to improve the design and conduct of medical device clinical investigations.
September 20
FDA approves first oral GLP-1 treatment for type 2 diabetes.  The U.S. Food and Drug Administration today approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with type 2 diabetes, along with diet and exercise. Rybelsus is the first glucagon-like peptide (GLP-1) receptor protein treatment approved for use in the United States that does not need to be injected. GLP-1 drugs are non-insulin treatments for people with type 2 diabetes.
September 19
FDA updates list of inquiries from prospective generic drug applicants about Referenced Listed Drug (RLD) access.   FDA has received numerous inquiries from prospective generic drug applicants who indicate being interested in developing a generic drug product but who report being unable to obtain samples of the reference listed drug (RLD) needed to support their applications because of limitations on distribution of the RLD.   To provide transparency regarding these inquiries, the agency published a list identifying all drug products about which FDA has received an RLD access inquiry, along with details including the name of the applicable RLD sponsor, the number of RLD access inquiries FDA has received about the product, and whether FDA has communicated directly to the RLD sponsor at the generic company's request. 

Abbreviated Approval Pathways for Drug Products: 505(b2) or ANDA? Determining the right abbreviated approval pathway for submitting a drug product application to FDA requires an understanding of the options available and what types of data are permitted to support a selection. FDA's final guidance for industry "Determining Whether to Submit an ANDA or 505(b)(2) Application" assists prospective applicants and provides direction in determining which one of these pathways is more appropriate.
A 505(b)(2) application is an NDA that contains full reports of investigations of safety and effectiveness, where at least some of the information required for approval comes from studies not conducted by or for the applicant, and for which the applicant has not obtained a right of reference or use, including, for example, the Agency's finding of safety and/or effectiveness for a listed drug or published literature. NDAs requiring full reports of investigations of safety and effectiveness that were conducted by or for the applicant, or for which the applicant has a right of reference or use, known as "stand-alone" NDAs, are submitted under section 505(b)(1) of the FD&C Act.

An ANDA is an application submitted and approved under section 505(j) of the FD&C Act for a drug product that is a duplicate of a previously approved drug product. It relies on FDA's finding that the previously approved drug product (the reference listed drug or RLD), is safe and effective, and may not be submitted if clinical investigations are necessary to establish the safety and effectiveness of the proposed drug product. An ANDA generally must contain information to show that the proposed generic product is the same as the RLD with respect to the active ingredient(s), conditions of use, route of administration, dosage form, strength, and labeling (with certain permissible differences) and is bioequivalent to the RLD.
September 18
Darmerica Voluntarily Recalls Quinacrine Due to Labeling Error.   FDA is alerting compounders and patients about a voluntary recall of two lots - DR4654A and DL4654A - of quinacrine dihydrochloride active pharmaceutical ingredients (API) from Darmerica LLC of Casselbury, Florida.  This API was incorrectly labeled as artemisnin which could seriously affect a patient's brain, heart, liver, kidney, immune system and reproductive system. 

Cognitive Performance in Adults Aged 60 and Over:  National Health and Nutrition Examination Survey, 2011-2014.  Using data from the National Health and Nutrition Examination Survey (NHANES), researchers found that adults with more frequent or worsening confusion or memory loss, called subjective cognitive decline (SCD), had poorer objective cognitive performance compared to adults without SCD.  In this study of a nationally representative sample of U.S. adults aged 60 years and older, it reports that people with SCD, low income, fewer years of education, older age, and fair or poor self-reported health were all associated with lower average scores on objective cognitive performance tests.

FDA issues final guidance to address 'gaming' by the use of citizen petitions.  "A key area of focus in the FDA's Drug Competition Action Plan is our work to deter brand-name drug companies from 'gaming' the system by taking advantage of certain rules, or exploiting loopholes, to delay competition. One of the anticompetitive tactics we've been concerned with involves companies submitting certain types of citizen petitions in order to delay FDA action on a generic or other abbreviated application.  The FDA has issued a final guidance, Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act which seeks to lessen the impact that FDA review of certain citizen petitions may have on any pending approval actions. 

September 17
CDER SBIA Pharmaceutical Quality Symposium Oct 16-17, 2019 ,  College Park, MD or Online | Free   FDA will discuss the latest developments in pharmaceutical quality and provide case studies that illustrate the most effective ways to address quality issues and interact with the agency.  To register online Control/Click on the colored title above.
September 13
FDA annual pesticide report finds that pesticide levels remain well below federal limits.  The FDA issued the final results of its annual Pesticide Residue Monitoring Program from foods collected in Fiscal Year (FY) 2017 which found that the vast majority of samples were below the tolerance levels set by the EPA. The agency tested 6,069 samples of domestic and imported foods for humans and animals in FY 2017 for more than 750 pesticides and industrial chemicals. The FDA found 96.2% of domestic and 89.6% of import human foods were compliant with federal standards. In addition, the FDA found 98.8% of domestic and 94.4% of import animal foods were compliant with federal standards.
September 12
FDA Issues Final Guidance for Special Premarket Notification [510(k)] Pathway
On October 31, 2019 at 1:00 PM EDT, the FDA will host a webinar to discuss these guidances.
September 9
Hidden Drug Ingredients.   Anaconda Strong Formula, Le Pepa Negra, LOBO, and Lung Leader all contain sildenafil, the active ingredient in Viagra.  Love in S and Sheaya Lender contain sibutramine which was removed from the market for safety reasons in 2010.  Mero Macho contains tadalafil, the active ingredient in Cialis.

FDA reopening the submission period for Quality Metrics Feedback Program.  The FDA announced in the Federal Register that it is reopening the submission period for the notice entitled "Modernizing Pharmaceutical Quality Systems; Studying Quality Metrics and Quality Culture; Quality Metrics Feedback Program" that originally published on June 29, 2018. The Agency is taking this action to allow interested persons additional time to participate in the program.  To be considered for the program, a company should submit a statement of interest for participation by December 30, 2019.
September 6
Electronic Drug Registration and Listing Using CDER Direct  October 22 2019   This CDER SBIA event is FREE. Attend in-person or online. Bring your laptop and submit your annual registration and listing renewals on the spot. The drug registration and listing staff is hosting a workshop dedicated to assisting industry with creating complete and accurate registration and listing submissions.  This year will focus on the top errors and mistakes observed with submissions and highlight FDA's newly announced process for inactivation of uncertified listings.
Septembert 3
Federal judge enters consent decree against Tennessee drug, dietary supplement and device distributors, Basic Reset and Biogenyx, for drug, device and dietary supplement violations.  A federal court has ordered two Tennessee-based companies and their owner to stop distributing drugs, dietary supplements and devices until the companies comply with the Federal Food, Drug, and Cosmetic (FD&C) Act and other requirements listed in a consent decree. According to the complaint filed with the consent decree, the defendants unlawfully distributed unapproved new drugs, adulterated and misbranded dietary supplements and an adulterated and misbranded device