Welcome to RxStrategies’ Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place. Contact us to learn more.
New Drug Approval
No new update.
New Formulation Approval
No new update.
New Indication/Dosage Approval
NucalaTM (mepolizumab) Injection – New Approved Indication – September 25, 2020 – GlaxoSmithKline plc (GSK) announced that the US Food and Drug Administration (FDA) has approved NucalaTM (mepolizumab) for the treatment of adult and pediatric patients aged 12 years and older with Hypereosinophilic Syndrome (HES) for ≥ six months without an identifiable non-haematologic secondary cause. The approval makes NucalaTM the first and only targeted biologic treatment to be approved for patients with this eosinophil-driven disease in the US. <Read More>
New Drug Shortage
September 28, 2020
- Ethambutol Hydrochloride Tablets (Discontinuation)
- Guanidine Hydrochloride Tablets (Discontinuation)
New Drug Recall and Safety Alerts
Riomet ER™ (Metformin Hydrochloride for Extended-Release Oral Suspension) by Sun Pharmaceutical Industries, Inc. – New Drug Recall – September 23, 2020 – Sun Pharmaceutical Industries, Inc. (SUN PHARMA), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of Riomet ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level. The reason for the recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the allowable Acceptable Daily Intake (ADI) limit established by the U.S. Food and Drug Administration. <Read More>
New Generic/Biosimilar Approval and Launch
No new update.
Clinical and Pharmacy News
Technological Advancements to Back the Biosimilars Insulin Market – September 28, 2020 – Biosimilars is a biological product designed to have similar active properties to the one that has been previously licensed and has no clinically significant differences in terms of safety and effectiveness. Biosimilars insulin is a type of biosimilars where it is indistinguishable to the reference insulin product and is already been approved by FDA or licensed. The producers of biosimilars use the similar manufacturing techniques as of the patented product but not likely identical to that used by the patent holder. Due to increasing insulin manufacturers from the developed and developing countries, the patents for insulin formulations had neared expiry or were ended. This created a necessity to seek approvals on biosimilar insulin for the not yet established companies in the highly regulated markets such as Europe and United States. In 2014, The European Commission (EC) first granted insulin treatment through the biosimilars pathway to Eli Lilly and Company and Boehringer Ingelheim GmbH. Lilly/Boehringer Ingelheim developed a biosimilar insulin called “Insulin glargine” and was the fourth diabetes product which was approved from Lilly-Boehringer Ingelheim Alliance in Europe. Basaglar is the first “biosimilar” insulin product to be approved and launched in U.S. which was developed by the alliance of Lilly/Boehringer Ingelheim. <Read More>
ASNC Releases New App to Support Cardiovascular Imaging Professionals – September 25, 2020 – A new smart-device application released by the American Society of Nuclear Cardiology (ASNC) will make it easier for cardiovascular healthcare professionals to learn and implement the latest evidence-based imaging to improve patient care. The “ASNC Clinical and Quality Resources App” contains key guidelines and educational materials in a single electronically searchable portal. It also offers the most up-to-date guidance on cardiac amyloidosis care in eight languages: Chinese, English, French, German, Italian, Japanese, Portuguese and Spanish. <Read More>
Guidelines are Necessary for Human Germline Editing – September 25, 2020 – Since its discovery in the late 1900s, genome editing has been at the center of many debates. Although the technology has rapidly evolved, ethical deliberation has not progressed at quite so fast a pace. While we know that we can edit the human genome, many scientists and non-scientists alike still question if we should. A new report by the International Commission on the Clinical Use of Human Germline Genome Editing recommends that strict conditions are met prior to the start of clinical germline gene editing in humans. Drafting this report appears to have been a wise choice for the future of genome editing. <Read More>
Hepatitis B Screening Before Cancer Therapy – September 25, 2020 – “Most patients with hepatitis B virus (HBV) infection do not know that they currently have or have had the infection,” explains Andrew S. Artz, MD, MS. “In patients whose immune systems are weakened—for example, due to immunosuppressive anticancer therapy—HBV can reactivate, start replicating, and lead to hepatitis flares, liver failure, and even death.” In response to awareness of patients with positive HBV test results who suffered serious liver outcomes during or after systemic anticancer therapy because they lacked an appropriate management plan, the American Society of Clinical Oncology (ASCO) updated its provisional clinical opinion (PCO) on HBV screening and management for patients with cancer before therapy, explains Jessica P. Hwang, MD, MPH. <Read More>
AAD, NPF Guidelines Urge Liver Disease Monitoring in Psoriasis Patients – September 25, 2020 – The American Academy of Dermatology (AAD) and the National Psoriasis Foundation (NPF), is urging physicians to monitor their patients on psoriasis medication for liver disease, citing jointly released guidelines. The latest guidelines provide prescribers with information and recommendations regarding the safety and efficacy of prescription medications for psoriasis, including methotrexate, an immunosuppressive agent utilized in therapy for psoriasis. In studies, Methotrexate has been associated with chronic liver injury, cirrhosis, progressive fibrosis and portal hypertension. <Read More>
Trump OKs Final Plan to Import Drugs From Canada – September 25, 2020 – President Donald Trump, outlining his “America First Health Plan” Thursday, announced that his administration will allow the importation of prescription drugs from Canada. The final plan clears the way for Florida and other states to implement a program bringing medications across the border despite the strong objections of drugmakers and the Canadian government. <Read More>
Patt: Payers Could Save More With Biosimilars – September 25, 2020 – “The birth of biosimilars is incredibly important,” but payers are missing an opportunity to save money with them, said Debra Patt, MD, PhD, MBA, a practicing oncologist and breast cancer specialist in Austin, Texas, and executive vice president of Public Policy and Strategic Initiatives for Texas Oncology. Patt was a featured speaker at The American Journal of Managed Care®‘s Patient-Centered Oncology Care® 2020 virtual conference, and she gave an overview of health care challenges facing the oncology profession and the broader health care community. <Read More>
Accord Healthcare Launches Herceptin Biosimilar in the UK – September 25, 2020 – Accord Healthcare has launched Zercepac (trastuzumab), a biosimilar of Roche’s Herceptin, in the UK after winning approval from the European Commission in July. The biosimilar is indicated for use as a treatment of certain patients with HER2-positive early and metastatic breast cancer, as well as previously untreated HER2-positive metastatic gastric cancer. The European Commission approval of Zercepac was based on a number of clinical studies including comparative quality studies, preclinical and clinical studies. The results confirmed the biosimilarity between the products, demonstrating comparable efficacy and safety to Herceptin. <Read More>
Acid Suppressants in Cardiac Patients: Sneak Peak of Clinical Guidelines – September 25, 2020 – Cardiovascular diseases (CVD) encompass a range of congenital or acquired pathological conditions that affect the structure or function of the heart, commonly, coronary artery disease (CAD), arrhythmia, myocardial infarction, cardiomyopathy, and peripheral artery disease…Acknowledging such evidence-based drug interactions and focusing on the patient customized risk-benefit ratios, there has been a paradigm shift in current recommendations that support only selective and not regular use of PPI in cardiac patients. As many recent investigations of this potential adverse interaction have been performed, using a variety of research designs, it has been difficult for practitioners to assimilate this flood of information and to develop an optimal and standard treatment protocol for managing patients who might benefit from antiplatelet therapy, yet who might suffer from GI bleeding. The present review is focused on highlighting the updated guidelines and recommendations on the rational use of PPIs in cardiac patients. <Read More>
Guidelines Updated for Managing Dyslipidemia to cut CVD risk – September 24, 2020 – (HealthDay)—In a synopsis of the 2020 updated clinical practice guideline from the U.S. Department of Veterans Affairs and the U.S. Department of Defense, published online Sept. 22 in the Annals of Internal Medicine, recommendations are presented for the management of dyslipidemia to reduce cardiovascular disease (CVD) risk. Patrick G. O’Malley, M.D., M.P.H., from the Uniformed Services University of the Health Sciences in Bethesda, Maryland, and colleagues developed key questions, evaluated the literature, and developed 27 recommendations and a simple algorithm for managing dyslipidemia to reduce CVD in adults. <Read More>
Working with Pharmacy Employees: Mistakes to Avoid – September 24, 2020 – The most important assets that the pharmacy has are its employees. When employees are doing their jobs and are working as a team, then the pharmacy functions smoothly and more successfully. On the other hand, human resources (HR) challenges can cause discord and can adversely affect productivity. This article discusses the most common HR problems that pharmacies face and the proactive steps that pharmacies can take to avoid these problems. <Read More>
Why More Alternative Care Sites are Leveraging Remote Pharmacy Services – September 24, 2020 – As patient volumes increasingly shift to non-acute settings, providers are looking to expand the pharmacy’s reach to provide a consistent continuity of care beyond the hospital. Clinical pharmacy work such as medication reconciliation and patient education, among others, have the added benefit of maximizing care continuity which can improve medication adherence. Though pharmacy’s importance in the care continuum is well understood, many alternate care sites don’t have the resources available to provide on-site pharmacy services 24/7. As a result, more providers are executing remote pharmacy services to supplement on-site staff to improve patient outcomes, explained Kelly Morrison, director of remote and retail pharmacy services at Dublin, Ohio-based Cardinal Health. <Read More>
Pharmacists May be First to Recognize Deterioration – September 24, 2020 – Mrs. Jones has been coming to the pharmacy for decades, but lately, she has not been her typical organized, perky self. Pharmacy staff members making calls to confirm routine medications have noted weeks of unused medications. Her weekly stops to the pharmacy have been replaced by more frequent requests for delivery. Since the death of her husband last year, her usual diligence in managing her affairs has shifted to increased confusion about her checkbook and medications…Pharmacists are perfectly positioned to assess and assist patients with functional health and, thus, cognitive health. Frequent and long-established therapeutic relationships are common in community pharmacies. It is reported that pharmacists see patients between 1.5 to 10 times more frequently than primary care physicians do. <Read More>
Barriers to Guideline-Concordant Treatment for Lung Cancer – September 24, 2020 – Receipt of guideline-concordant treatment significantly improves 2-year mortality outcomes for patients with lung cancer, indicating that interventions to reduce inequalities to guideline-concordant treatment could improve lung cancer outcomes, according to a study published in Cancer, Epidemiology, Biomarkers & Prevention. “Guideline-concordant treatment… of lung cancer has been observed to vary across geographic regions over the years. However, there is little evidence as to what extent this variation is explained by differences in patients’ clinical characteristics versus contextual factors, including socio-economic inequalities,” wrote Win Wah, Monash University, Victoria, Australia, and colleagues. <Read More>
Heart Failure Publications, Trial Research Continue to Lack Women Authors – September 24, 2020 – Heart failure (HF) research led by women continues to lag behind that of men, so that less than 20% of first authors and less than 15% of senior authors are women, according to findings published recently in Circulation: Heart Failure. This is despite close to 25% of physicians and researchers in the space being women. “The research is the first of its kind to explore gender disparities in authorship of [heart failure] guideline citations and clinical trials,” the study authors noted, adding that their data show consistent low numbers of women authors across guidelines and heart failure trials. <Read More>
California Adds Rules to ‘No Pharmacist Left Alone’ Law – September 24, 2020 – California’s board of pharmacy approved the addition of new regulations to its “No Pharmacist Left Alone Law,” which requires pharmacies to ensure pharmacists aren’t the only person working in a pharmacy, according to JD Supra, a company that provides legal information. The state originally passed the law in 2018 to address concerns of inadequate staffing in community pharmacies. Inadequate staffing impairs pharmacists’ judgment and ability to do their jobs, and endangers public health because it leaves pharmacists unable to do their job safely, according to JD Supra. <Read More>
FDA’s Eva Temkin Discusses Biosimilar Approvals at ACI – September 23, 2020 – Eva Temkin, acting director for policy at the Office of Therapeutic Biologics and Biosimilars (OTBB), provided a snapshot of how the FDA’s new office is faring in her keynote talk at the American Conference Institute’s 11th Summit on Biosimilars & Innovator Biologics. The OTBB was established in 2018 to help usher the development of biosimilars and thereby lower health care spending and improve patient access. “What we really wanted to do was say, ‘We’re committed to this. We recognize that there are a lot of things that the agency can do to help this marketplace grow and become stable,’” Temkin said in the discussion that was moderated by Amanda Hollis, JD, a patent litigator with Kirkland & Ellis of Chicago. <Read More>
Active Tuberculosis Linked to Higher Long-Term Risk of Death – September 23, 2020 – In a retrospective Kaiser Permanente study, people who recovered from active tuberculosis had a higher long-term risk of death from any cause than similar patients who never had active tuberculosis. The study, “Association of Mortality and Years of Potential Life Lost with Active Tuberculosis in the United States,” was published online on September 23 in the journal JAMA Network Open. Tuberculosis is a potentially deadly mycobacterial disease that attacks the lungs. A person who becomes infected with tuberculosis may not have any symptoms initially (“latent” infection), but if their immune system weakens, the bacteria may become active and cause illness. However, screening can detect a latent infection, and treatment can prevent it from becoming active. <Read More>
FDA to Tighten Vaccine Approval Requirements; Face Shields Alone Don’t Reduce Virus Spread, Study Suggests — 8 COVID-19 Updates – September 23, 2020 – The U.S. has reported an average of 41,490 new COVID-19 cases daily in the past week, up 13 percent from the average seen two weeks ago, reports The New York Times. At least 22 states are reporting an uptick in cases as of Sept. 23, compared to just nine states on Sept. 14, according to CNN’s analysis of data from Baltimore-based Johns Hopkins University. Eight updates: 1. The FDA is set to issue stricter emergency authorization requirements for a COVID-19 vaccine, reports The Washington Post. The new standards will make it more challenging to clear a vaccine before Election Day in an attempt to improve public confidence in the agency. Currently under review by the White House Office of Management and Budget, the proposed changes include manufacturers following participants in late-stage clinical trials for at least two months, two people familiar with the situation told the Post. 2. Johnson & Johnson’s single-shot COVID-19 vaccine has entered the final stage of testing, according to The Washington Post. The vaccine is the first single-dose vaccine to enter a large, phase 3 clinical trial in the U.S., and the fourth experimental vaccine total to enter said phase. <Read More>
Early Treatment for Venous Leg Ulcers Delivers Clinical Benefits and Cost Savings – September 23, 2020 – Venous leg ulcers are common and distressing, affecting around 1 in 300 adults in the UK. They are open, often painful, sores on the leg that take months to heal and can develop after a minor injury. People with enlarged veins known as varicose veins are at high risk of developing venous leg ulcers, as they have persistently high pressure in the veins leading to skin damage. In a clinical trial, led by researchers at Imperial College London and clinicians at Imperial College Healthcare NHS Trust, 450 patients with venous leg ulcers were treated with early surgical interventions. This resulted in faster healing and a reduced risk of the condition coming back compared with current methods of treating patients with compression stockings and delayed surgical interventions. <Read More>
Specialty Pharmacies Offer Valuable Data to Stakeholders – September 23, 2020 – A range of stakeholders speaking at the National Association of Specialty Pharmacy 2020 Annual Meeting & Expo Virtual Experience had a clear message for specialty pharmacies: We want your data. One presenter said data collected through prior authorizations, for example, can help manufacturers understand why some prescriptions are left unfilled. “Perhaps the diagnosis isn’t correct,” said Cheryl Allen, the principal consultant at Blue Fin Group, a life sciences management consulting firm in the Greater Philadelphia area. “Or maybe there’s a lack of education among the prescribers on the use of the drug.” <Read More>
New Guidelines for Maximizing Cures and Minimizing Side Effects in Children with Hodgkin Lymphoma – September 23, 2020 – The National Comprehensive Cancer Network® (NCCN®) announced that the publication of new NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Pediatric Hodgkin Lymphoma. Hodgkin lymphoma is one of the most curable forms of pediatric cancer, with long-term survival rates of 90% or higher. However, treatment can result in potentially life-threatening or -altering long-term side effects. These new recommendations from NCCN synthesize the latest evidence and expert-consensus to make sure every child receives appropriate, but not excessive, treatment. <Read More>
NICE Board Agrees to Stimulate Action Following Publication of Independent Medicines and Medical Devices Safety Review Report – September 23, 2020 – The NICE board has agreed more work will be carried out with regulators and professional organisations to reinforce the use of NICE guidance. The report of the Independent Medicines and Medical Devices Safety (IMMDS) Review in July, entitled First Do No Harm, found that had NICE guidance been followed more closely then much of the subsequent harm suffered by patients may have been avoided. The purpose of the review, led by Baroness Julia Cumberlege, was to examine how the healthcare system in England responded to reports about harmful side effects from: 1) Primados (a hormonal pregnancy test – withdrawn from sale in UK in 1978), 2) Sodium Valproate (in pregnancy) and 3) Surgical Mesh (for pelvic organ prolapse and stress urinary incontinence). <Read More>
Report: Prescription Drug Costs can be Lowered Without Legislation – September 23, 2020 – As the costs of prescription and health care continue to rise during the coronavirus disease 2019 (COVID-19) pandemic, a report by the Center for American Progress (CAP) disclosed ways in which the president can lower costs without the need for new legislation. CAP is a liberal public policy research and advocacy organization. Prescription drug net prices increased by an average of 4.5% per year from 2007 to 2018, “a rate far greater than average annual inflation,” said authors of the report. In 2020, drug companies have raised the prices of more than 800 drugs—40 in July. The report suggests means by which the current sitting president or the one elected in November 2020 can take immediate actions to alleviate these problems and make drugs more accessible to a broader swath of the population. <Read More>
Four Reasons to Avoid the GoodRx IPO – September 23, 2020 – Initial public offerings from consumer-focused digital healthcare platforms have been terrific sources of gains for investors in 2020, and there’s another big one on the way. Shares of GoodRx (NASDAQ:GDRX) are expected to begin trading soon, and plenty of everyday investors find the company’s prospectus compelling. Digital coupons that route sales of prescription drugs through a pharmacy benefit manager (PBM) are increasingly popular. GoodRx — a price comparison app that offers such coupons — stands to benefit from that rise. Before you dive in, though, there are a few things you should know. <Read More>
LTC Pharmacies Crucial for Nursing Home Vaccine Distribution, But Financial and Logistical Hurdles Loom – September 23, 2020 – The hopes of pretty much everyone in the country now rest on the distribution of a safe and effective COVID-19 vaccine, and for nursing home residents and their families, the stakes are even higher: With significantly elevated risk of fatalities from the novel coronavirus among the frail and elderly, the race for a vaccine is a life-or-death proposition for millions of Americans and their loved ones. But long-term care pharmacies, which will likely serve as the primary vector for coronavirus vaccine distribution in the setting, haven’t been immune to the financial turmoil that the rest of the health care industry has weathered — and a top advocate for the sector says the government needs to provide significantly more relief for LTC pharmacies if it expects a smooth vaccine rollout. <Read More>
Not Yet Sweet on Wormwood for COVID-19 – September 22, 2020 – A hardy and prolific plant known as sweet wormwood, or Artemisia annua, contains a potent ingredient that could become a new medicinal weapon in the battle to stem the COVID-19 pandemic. Or it could be just one more promising treatment that showed strong antiviral activity in the laboratory but failed in human trials against an implacable foe. That question is what investigators at the University of Kentucky (UKY) are determined to answer. <Read More>
FDA Issues New Guidance on Nitrosamine Impurities in APIs and Drug Products – September 22, 2020 – Our FDA Compliance & Enforcement Team reviews how the Food and Drug Administration’s first guidance on nitrosamine impurities shows what the FDA has learned about the sources of such impurities and what manufacturers can do to prevent unacceptable levels of them…On September 1, 2020, the U.S. Food and Drug Administration (FDA) issued Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs to provide the agency’s current thinking on the issue of nitrosamine impurities in active pharmaceutical ingredients (APIs) and drug products. <Read More>
Pharmacists Are Essential to Maintaining Immunizations During Pandemic – September 22, 2020 – With the approaching flu season and a vaccine for coronavirus disease 2019 (COVID-19) on the way, pharmacists are playing a more important role than ever in ensuring that patients remain up-to-date on immunizations. For a recent Pharmacy Times® webcast, several experts discussed how pharmacists’ roles are changing and some of the new precautions implemented at pharmacies. Although the COVID-19 pandemic has been massively disruptive to the medical field, Brian Hille, BSPharm, vice president of patient, specialty and wellness services at Albertsons Companies in Boise, Idaho, said that continuing to provide necessary services has become more important than ever. Because pharmacists provide a large percentage of immunizations across the country, maintaining that source is vital to ensuring patients’ ongoing health, he said. <Read More>
APhA Board of Trustees Issues Statement on Women in Pharmacy and Harassment – September 22, 2020 – A recent change.org petition called on national pharmacy organizations to address the ways women in pharmacy are silenced. The petition inspired a wave of women to share their own stories of abuse and harassment based on their gender. The petition also led to discussions about the unfairness of guilty parties receiving tenure-track promotions, positions of power, and professional awards and accolades with no consideration of their unprofessional and destructive treatment of their women peers…The APhA Board of Trustees is calling on all organizations and individuals to join the fight against sexism, racism, discrimination, harassment, and intimidation. <Read More>
Pharmacy Accreditors Adapt Procedures to COVID-19 Pandemic – September 22, 2020 – Leading accreditation bodies for specialty pharmacy have modified their procedures and requirements for both ongoing reporting and initial accreditation in response to the COVID-19 pandemic, according to representatives of two of those organizations who spoke at a session on specialty pharmacy accreditation at the National Association of Specialty Pharmacy 2020 Annual Meeting & Expo. <Read More>
Urinary Tract Infections Affect Men as Well as Women – September 22, 2020 – Urinary tract infections (utis) are thought of as a female issue and are, in fact, more common in women, but men get them, too. Pharmacists can help male patients prevent UTIs, identify the symptoms, and treat these tricky conditions. Keep in mind that men who have UTIs may feel confused or embarrassed. Let’s first look under the hood. UTIs occur because of bacterial growth in the urinary system through the urethra, which carries urine from the bladder to the tip of the penis. The reason that women are more susceptible to UTIs is the female urethra is shorter than the male urethra. On average, the female urethra is just 4 cm long compared with the male urethra, which is generally 20 cm long. As men have longer urethras than women, they are less prone to UTIs because bacteria need to travel a longer distance to reach the bladder. Most UTIs are caused by a bacteria called Escherichia coli (E coli). <Read More>
Two Chief Pharmacy Officers on the Skills They Wish They had Learned Sooner – September 22, 2020 – The pharmacy department is uniquely positioned to help hospitals and health systems improve patient outcomes, safety and financial performance, making pharmacists and pharmacy leaders well-equipped to help the organization succeed. However, leading the pharmacy department in the chief pharmacy officer role requires a different set of skills and experiences than leading the clinical-facing side. During a session at the Becker’s Virtual Pharmacy Event Sept. 22, a panel of pharmacy executives discussed some of the skills, accomplishments and learning experiences that helped them succeed and the skills they wish they had learned earlier in their careers. <Read More>
340B in the News
Legislative Democrats and Republicans lay out Health Policy Priorities – September 28, 2020 – Seven legislators with influence over Washington State health policy gathered last week to discuss their observations on health and fiscal policy since the previous legislative session ended, and how the pandemic in 2020 will impact the work of the Legislature in 2021. The discussion took place between two panels – one featuring Republicans and the other featuring Democrats – at the 2020 Inland Northwest State of Reform Virtual Health Policy Conference. The Republican Policy Leadership panel featured Reps. Joe Schmick, Jacquelin Maycumber, and Paul Harris. Sens. Karen Keiser, Annette Cleveland, Emily Randall, and Rep. Marcus Riccelli carried the torch for Democrats. Below are highlights from the wide-ranging discussions that took place in both panels. <Read More>
340B Update: Congress and the Administration Respond to Drug Manufacturers’ 340B Contract Pharmacy Actions – September 28, 2020 – In recent weeks, several drug manufacturers have taken actions that impact covered entities participating in the 340B Drug Pricing Program (340B Program) and their contract pharmacies. Eli Lilly and Co. (Eli Lilly) and AstraZeneca informed covered entities that they will stop replenishing drugs to 340B contract pharmacies and limit distribution to covered entities and their child sites only. In addition, Merck, Sanofi, and Novartis requested that covered entities share contract pharmacy claims data through Second Sight Solutions’ 340B ESP platform. Sanofi explicitly indicated that failure to participate would result in a similar refusal to replenish contract pharmacy claims. In response, several provider groups and policymakers have written to the Department of Health and Human Services (HHS) and the Health Resources and Services Administration (HRSA) asking them to intervene. HHS recently responded to some of these actions. This client alert provides an overview of these developments and impact on 340B Program stakeholders. <Read More>
UPDATE: Congress and the Administration Respond to Drug Manufacturers’ 340B Contract Pharmacy Actions – September 26, 2020 – In recent weeks, several drug manufacturers have taken actions that impact covered entities participating in the 340B Drug Pricing Program (340B Program) and their contract pharmacies. Eli Lilly and Co. (Eli Lilly) and AstraZeneca informed covered entities that they will stop replenishing drugs to 340B contract pharmacies and limit distribution to covered entities and their child sites only. In addition, Merck, Sanofi, and Novartis requested that covered entities share contract pharmacy claims data through Second Sight Solutions’ 340B ESP platform. Sanofi explicitly indicated that failure to participate would result in a similar refusal to replenish contract pharmacy claims. In response, several provider groups and policymakers have written to the Department of Health and Human Services (HHS) and the Health Resources and Services Administration (HRSA) asking them to intervene. HHS recently responded to some of these actions. This client alert provides an overview of these developments and impact on 340B Program stakeholders. <Read More>
HHS General Counsel Scolds Eli Lilly for Halting 340B Drug Discounts – September 24, 2020 – HHS General Counsel Robert Charrow scolded Eli Lilly in a Sept. 21 letter for its recent actions to halt 340B discounts to hospitals. In the letter, Mr. Charrow scolded Eli Lilly for seeking to impose deadlines on which its 340B discounts would be reduced if the Human Resources and Services Administration didn’t respond to its actions, and for maintaining that its correspondence with HRSA were trade secrets. The drugmaker cannot impose such deadlines on the government’s deliberations, he said. “Lilly cannot and should not view the absence of any questions from the government as somehow endorsing Lilly’s policy especially when this Department is leading the government’s response to the COVID-19 pandemic,” Mr. Charrow wrote. <Read More>
Bipartisan Group of Senate, House Lawmakers Press HHS to Quash Drug Companies’ 340B Moves – September 24, 2020 – Congress can’t seem to agree on much, but large bipartisan majorities in the House and the Senate did agree to slam drug companies for restricting access to 340B drugs sold via contract pharmacies. A group of 243 House lawmakers and 28 senators sent letters last week to Department of Health and Human Services Secretary Alex Azar over a series of moves drug companies have made on the 340B drug discount program. The lawmakers urge swift action from Azar to restrict the moves, which they say are hurting providers. <Read More>