February 2019
Specialty Pharma Industry News is provided by SPA Member Dr. Larry Boos
(This month's news is limited due to the recent partial government shutdown.)
January 31
FDA has Investigated Recalled Duncan Hines Cake Mixes Potentially Linked to Salmonella Agbeni Illnesses.  Although on January 14, 2019, the CDC reported that this outbreak appears to be over; however, the FDA recommends consumers to not bake with or eat the recalled product. Additionally, consumers should not eat uncooked batter, flour, or cake mix powder.
Today, the U.S. Food and Drug Administration issued a Safety Communication titled "Intravascular Air-in-Line and Air Embolism Risks Associated with Infusion Pumps, Fluid Warmers, and Rapid Infusers".
If a significant amount of air is introduced into a blood vessel, it can travel through the blood vessels and become lodged in critical organs such as the brain, heart, or lungs. This is known as an "air embolism," which can be life threatening because it may prevent oxygen from reaching those critical organs. Without oxygen, the tissues or organs become damaged.  While air-in-line sensors are meant to prevent, or reduce the risk of air embolisms, there can sometimes be false alarms or nuisance alarms. With a false alarm, the device may generate an air-in-line alarm when air is not present, or the amount of air detected is so small that it would not present a risk to the patient. When the device alarms, it stops the infusion, which may cause delays or an interruption of therapy.  When a device stops infusing, this could be problematic if critical medications (for example, Epinephrine) are being infused.  FDA recommends that you Plan Ahead (for example, know how to use the device properly, and have a backup plan) and Monitor (for example, inspect and maintain the device, and watch for patient signs or symptoms).
January 30
Recall Notice Updated- Infants' Ibuprofen Concentrated Oral Suspension by Tris Pharma: Recall - Due to Potential Higher Concentrations of Ibuprofen.   Three additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, have been added.  You can read the complete recall alert here.

FDA approves first generic Advair Diskus.  Generic Advair Diskus (fluticasone propionate and salmetrol) inhalation powder is available from Mylan Laboratories in 100 mcg/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg, and an important treatment for patients living with asthma and chronic obstructive pulmonary disease (COPD), including bronchitis and emphysema. In America, 26 million people, including millions of children, have asthma and 16 million people are living with COPD. Today's approval should provide greater access to this medication for these patients.  Read the News Release here.

On December 18, 2018, the US Surgeon General officially declared e-cigarette use among youth an "epidemic."   Laurie Scudder, editorial director at Medscape, is joined by the US Surgeon General, Vice Admiral Jerome Adams; and the FDA Commissioner, Dr. Scott Gottlieb, to discuss this public health emergency. Watch or read the entire Medscape interview.

Blood-brain barrier test may predict dementia   A new study suggests that measuring the breakdown of the blood-brain barrier could be an early way to test for cognitive impairment from Alzheimer's disease and other causes. Control/Click on the colored title above to read more.

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency's efforts to enhance the utility of the Orange Book to foster drug competition. One of the first steps to be taken to ensure that the Orange Book provides the greatest benefit to patients and providers, and generic drug developers is the issuance of a new draft guidance - Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format.  Separately, The FDA will also be soliciting public comment on Orange Book use and potential enhancements, including a re-examination of what pharmaceutical patents should be listed in the Orange Book.
January 29
Nature's Rx Issues Voluntary Nationwide Recall of Silver Bullet 10x.  This recall has been initiated because the product was found to contain undeclared sildenafil and tadalafil, the active ingredient in Viagra and Cialis respectively, which are PDE-5 inhibitors. The undeclared PDE-5 inhibitors in the product may pose serious health risks because consumers with underlying medical issues may take the products without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) and thus can lower blood pressure to dangerous levels.  Consumers with diabetes, high blood pressure, or heart disease often take nitrates.
January 10
Slimina contains hidden drug ingredient, Sibutramine.  Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. This product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or heart rate in some people and may present a significant risk for people with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.
January 8
NIH: Connecting Senescent Cells to Obesity and Anxiety.   Obesity-which affects about 4 in 10 U.S. adults-increases the risk for lots of human health problems: diabetes, heart disease, certain cancers, and even anxiety and depression. It's also been associated with increased accumulation of senescent cells, which are older cells that resist death even as they lose the ability to grow and divide. Read more...
Meet Our Conference Speakers
Doug Long

Doug's dedication and leadership in healthcare span four decades. Doug has unparalleled experience and perspective on pharmaceutical distribution and the changing U.S. and global healthcare marketplace.
As Vice President of Industry Relations for IQVIA - the world's largest pharmaceutical information company - Doug has been a leader with the company since 1989 in implementing health databases, developing new products and fostering relationships with distributors, manufacturers, retailers, and industry associations.

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William A. Garvin, Esq.

William focuses his practice on issues related to the approval, regulation, promotion, sale, and reimbursement of drugs, medical devices, biologics, excipients, dietary supplements, and foods.

William assists clients in their interactions with various federal agencies including Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), Drug Enforcement Agency (DEA), Federal Trade Commission (FTC) and Health and Human Services (HHS)

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Ira Z. Leiderman
Managing Director

Ira Leiderman is a highly experienced healthcare investment banker and executive. He applies his extensive expertise and relationships within the health care, life sciences, investment banking, and U.S. capital markets arenas to help advance clients' goals. For more information click here.

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Steve Friedman, R.Ph.
Vice President, Pharmaceutical Trade Relations

Steve joined PDX in 2007 with the primary responsibility of developing pharmacy level patient-centric programs residing in the PDX pharmacy system in collaboration with Pharma, PDX Manufacturer Services. He oversees all aspects of this important initiative. His nearly 40 years of executive-level experience within the pharmaceutical industry has provided PDX customers an invaluable resource for those critical patient touch-points at the pharmacy level.

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Michael P. Strazzella
Administrative Head, D.C. Office
Practice Group Leader, Federal Government Relations

Michael has deep experience in federal government relations, legislative strategy, grassroots advocacy, political action campaigns, and coalition building. He focuses his practice on the health industry (providers and payors) and works in various industries, including pharmaceutical, hospital and health systems, health plans and retail and compounding pharmacy industries. Adept at navigating relationships, Michael works closely with Congress and the Executive Branch, including the Department of Health and Human Services; Centers for Medicare and Medicaid Services; the Food and Drug Administration; U.S. Customs; and the Drug Enforcement Administration to create effective lobbying strategies as they apply to the health care sector.

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