Under a proposed settlement reached with the United States and the state of Indiana, the Atlantic Richfield Company and E.I. Du Pont de Nemours and Co. will pay for an estimated $26 million cleanup of lead and arsenic contamination in parts of a residential neighborhood in East Chicago, Indiana, announced the U.S. Department of Justice and the U.S. Environmental Protection Agency.

A Canton, Massachusetts, man was arrested today at Boston's Logan International Airport in connection with the ongoing criminal investigation of New England Compounding Center by the Justice Department’s Civil Division and U.S. Attorney’s Office for the District of Massachusetts.

A federal jury returned guilty verdicts today against former Virginia Governor Robert F. McDonnell and former First Lady of Virginia Maureen G. McDonnell for participating in a scheme to violate federal public corruption laws.

John P. Carlin, Assistant Attorney General for National Security and Wifredo A. Ferrer, United States Attorney for the Southern District of Florida, announced today that U.S. District Judge Marcia Cooke re-sentenced Jose Padilla to serve 21 years in prison for his 2007 conviction for conspiracy to murder, kidnap and maim individuals in a foreign country; conspiracy to provide material support to terrorists; and providing material support to terrorists.

Shannon Conley, age 19, of Arvada, Colorado, pleaded guilty this morning before U.S. District Court Judge Raymond P. Moore to one count of conspiracy to provide material support to a designated foreign terrorist organization, U.S. Attorney John Walsh for the District of Colorado and Special Agent in Charge Thomas Ravenelle of the FBI Denver Division announced. Conley is scheduled to be sentenced by Judge Moore on January 23, 2015. The defendant appeared at the change of plea hearing in custody, and was remanded at its conclusion.

The Justice Department announced Monday that Attorney General Eric Holder has recorded a video message as part of the Cartoon Network’s “I Speak Up” campaign to combat bullying. The project urges young people to speak up in order to help bring bullying situations to an end.

Attorney General Eric Holder, Assistant Attorney General for National Security John Carlin and U.S. Attorney William J. Hochul Jr. for the Western District of New York announced today that a federal grand jury in Rochester has returned a seven-count indictment charging Mufid A. Elfgeeh, 30, of Rochester, with three counts of attempting to provide material support and resources to the Islamic State of Iraq and the Levant (ISIL), aka the Islamic State of Iraq and Syria (ISIS), a designated foreign terrorist organization. In addition, Elfgeeh is also charged with one count of attempted murder of current and former members of the United States military, one count of possessing firearms equipped with silencers in furtherance of a crime of violence, and two counts of receipt and possession of unregistered firearm silencers.

Attorney General Eric Holder announced today that the Department of Justice and 19 states and the District of Columbia have entered into a $1.375 billion settlement agreement with the rating agency Standard &s Financial Services LLC, along with its parent corporation McGraw Hill Financial Inc., to resolve allegations that S&s 2013 lawsuit against S& true credit risks. Other allegations assert that S&s business relationships with the investment banks that issued the securities.

By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate   What’s New in: Therapeutic Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html Biologics and Genetic Therapies Directorate: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html   Updates from Health Canada Type of Update and Link Date Posted Notice – Update to Clinical Trial Site Information Form 29 November …

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By Alice Li, MD, MSc, RAC(CAN), Regulatory Scientist, Cato Research Special Interest Guidances/Information Date Posted Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics – Final Guidance 30 Dec 2019 Submission of Plans for Cigarette Packages …

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By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS Special Interest Guidances/Information Date Posted Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry: Draft Guidance for Industry – Draft Guidance 30 Jan 2020 Arthroscopy Pump Tubing Sets …

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  By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate   What’s New in:   Therapeutic Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html Biologics and Genetic Therapies Directorate: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html   Updates from Health Canada   Type of Update and Link Date Posted Notice: Product Monograph Implementation Plans 13 January 2020 …

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By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS    Special Interest Guidances/Information Date Posted Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories and Food and …

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By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS FDA guidances from March 2020 as well as upcoming advisory committee meeting announcements are below.  We note that approximately one-third of FDA’s guidances this past month are related to COVID-19.    Special Interest Guidances/Information Date Posted Enforcement Policy for Gowns, Other Apparel, and …

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By Zachary Swan, PhD, RAC, Associate Director, Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 30 April 2020 FDA Deems Certain Tobacco Products Subject to FDA Authority, …

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Lupin Pharmaceuticals Inc. (LUPIN, 500257) on Monday announced positive top-line results from its pivotal Phase 3 clinical trial to assess the efficacy and safety of single-dose Solosec or secnidazole 2g oral granules in 147 female patients with trichomoniasis.

Sutro Biopharma Inc.'s (STRO) interim phase I updated clinical data for a dose-escalation study of antibody drug-conjugate STRO-002 in ovarian cancer has been encouraging.

Biopharmaceutical company RedHill Biopharma Ltd. (RDHL) on Monday provided an additional update on the compassionate use program with its investigational drug, opaganib (Yeliva, ABC294640)1, in patients with confirmed SARS-CoV-2 infection (the cause of COVID-19) in Israel.

Biotech is in the midst of an incredible era of innovation: new modalities and novel medicines delivering real value to patients, leading to a decade-long bull cycle. It’s been exhilarating to watch and participate in this market, and venture capital

The post Wither New Biotech Startups? appeared first on LifeSciVC.

Rend Al-Mondhiry has joined the firm Amin Talati from the Council for Responsible Nutrition (CRN) as Senior Counsel, resident in the Washington, D.C. Office.

Nutrition 21, LLC has announced its Nitrosigine® is now featured in EVERTRAIN PRE, a recently launched pre-workout supplement designed to provide athletes with sustained energy, superior focus and increased endurance.

Another leading athlete has joined Arla Foods Ingredients’ growing number of brand ambassadors for Lacprodan® HYDRO.365.

In this SupplySide West edition of the Healthy INSIDER podcast, Rachel Adams, managing editor, and Scott Steinford, founder and CEO of Trust Transparency Consulting, discuss the role of transparency in establishing trust with supplements consumers.  

The chief executive of a supplement company under investigation by FDA could go to prison for allegedly violating the terms of his supervised release following a criminal conviction in 2014.

A doctor, researcher and former chronic migraine sufferer, has launched her own biotech startup company named KetoSwiss selling supplements that she argues can help control migraine pain by tapping into our own biological mechanisms.

French beauty supplement firm D+ For Care has launched a mouth spray to aid sleep and has a flurry of holistic wellbeing innovation primed for 2020 â the year nutricosmetics could really take off, its founder says.

APEC continues to bolster ethics in the healthcare sector in support of small and medium enterprises (SMEs) and patients, as Chile launches a consensus framework to improve ethical interactions in its healthcare system.

APEC economies, data privacy regulators, and other stakeholders are exploring ways to bolster the Cross-Border Privacy Rules (CBPR) system.

APEC member economies launched the APEC Women in STEM Principles and Actions, a set of suggested principles and actions for encouraging women’s participation in the fields of science, technology, engineering, and mathematics, commonly referred to as STEM.

The impact of corruption is far-reaching and devastating, especially for women.

Business leaders from around the Asia-Pacific met in Sydney last week to discuss the year ahead

Malaysia, the host of APEC 2020, has announced the postponement of the upcoming Second Senior Officials’ Meeting, the 2020 APEC Tourism Ministerial Meeting, and the 2020 APEC Ministers Responsible of Trade Meeting, which were scheduled for April this year.

Reflecting the discussions of the Health Working Group which met at the First APEC Senior Officials Meeting, 7-8 February 2020, Putrajaya, Malaysia

From : Communities>>Regulatory Open Forum
Hi Annie, I knew before that I wouldn't be able to attend to the webcast, so I did not register for it. But I am very curious on Dr. Akras insights. Is it possible to view a recording of it? Thanks, Britta ------------------------------ Britta Cyron Bochum Germany ------------------------------

From : Communities>>Regulatory Open Forum
Hi @Britta Cyron , Thanks for your question. Let me connect with m​y RAPS colleagues on this to get you an answer and then I will follow-up with you directly. Best, Annie ------------------------------ Annie O'Brien Community Manager Regulatory Affairs Professional Society regex@raps.org ------------------------------

From : Communities>>Regulatory Open Forum
Thank you for posting this here Annie as the webcast was excellent (as would be expected from Dr. Akra haha) - but really it was great to have this publicly available as there was nice information about the EU MDR conveyed. ------------------------------ Richard Vincins RAC Vice President Global Regulatory Affairs ------------------------------

Last month, I scheduled one-on-one discussions with our most experienced GCP auditors to ask each of them the same question: What surprises you most about the audits you conduct?

I guess you could say that I was the one who was surprised. I’m not sure exactly what I was expecting to hear, but I thought my teammates were going to talk about things that were new. Instead, I heard a lot more about things that have been around for a long time. To a person, my colleagues said they were surprised to be observing some of the same audit findings they were observing 30 years ago...which *is* surprising when you consider most of them were mere children at the time. ;-)  It seems we have some stubbornly persistent quality and compliance issues in the biopharma industry that decades of neither experience nor technology have seemed to remedy. And the problems are not just persistent; they’re interrelated.



Standard Operating Procedures (SOPs)
It’s quite common for auditors to encounter sponsors, CROs, and sites that lack an adequate set of SOPs to describe local procedures. There are several reasons for this. Sometimes it’s a lack of resources. Sometimes smaller, established organizations believe writing it all down is unnecessary, as “people know their jobs.” Sometimes newer companies are simply unaware that written procedures are required for particular operations. But when procedures are not documented, organizations are unable to demonstrate GCP compliance, cannot ensure that activities are performed correctly or consistently, and have difficulty training new staff members. (We’ll come back to training in a bit.)

Frequently missing from a good working set of SOPs are procedures for Disaster Recovery, Handling of Suspected Fraud, and Management of Regulatory Inspections. These SOPs are not used for day-to-day operations, so perhaps that’s why they don’t garner as much attention. Nevertheless, the inability to recover from a disaster, protect the organization from fraud allegations, or pass a regulatory inspection can sink a company.

A fourth SOP that is commonly absent from the set is the document that describes how to write, approve, distribute, revise, and retire SOPs. Also frequently missing from a working set of SOPs is our next topic: Training.

Training
Training can be expensive and time-consuming, and companies increasingly have to do more with less. In-person training has largely been replaced by computer-based systems, on-site training has given way to distance learning, and mentoring has gone the way of the dodo.

The good news is that study sites typically adhere to formal GCP training requirements. What’s often missing, though, is the training that connects GCP concepts to everyday activities. A trainee might correctly answer a multiple-choice question about audit trails, but without that “last mile” of coaching, use Wite-Out to correct a source document error. This is where SOPs come in. When training is conducted using well-written SOPs, it can help bridge the gap between standard GCP training and specific site operations.

It is not uncommon for study-specific training to be lacking in CROs – protocol training, device training, computer systems user training. As part of their vendor oversight procedures (also an SOP!), sponsors should be making sure that CRO staff is adequately trained. 

Trial Master Files (TMFs)
Whether paper or electronic, it’s common for TMF documents to be missing or expired. Replacements for these documents can usually be produced and filed at the time of the audit. Misfiled documents are another matter; they are already there but cannot easily be found. Locating and refiling them essentially doubles the time and cost of the original effort. For example, documents from multiple labs, such as certificates, credentials, vendor audit results, etc., are often mistakenly commingled. Documents must be sorted and refiled so that each facility listed on the 1572 has its own file or electronic folder.


Another very common mistake is treating every document on letterhead as if it’s general correspondence. Search for the word “letter” in the DIA Reference Model and you can see how many opportunities exist for misclassifying correspondence. For example, an IND safety report sent by the sponsor on letterhead should be filed under “Notification of Safety Information,” Section 8.3.18 in ICH E6(R2), not “Relevant Communications,” Section 8.3.11. In an eTMF, an IRB approval letter belongs in 04.01.02, its designated DIA Reference Model position, not 04.04.01, which is reserved for general communication.

The root cause of these misfilings? The filer does not know enough about the filing structure of the TMF and often is not familiar enough with clinical research to know the purpose of each document and where it belongs. The corrective action? Training. Training on the TMF plan, the TMF Management SOP, ICH GCP, and study operations in general.

Technology to the Rescue?
No doubt, CTMSs, eTMFs, eCRFs, ePRO, and other systems have improved clinical operations and reduced error. However, three decades of technological advances have done little to address the most common quality and compliance issues encountered by GCP auditors – and by extension regulators. Some might find that discouraging, but isn’t it also a little satisfying that the solution to our most persistent problems comes down to human communication?

______________________________________________________________________
A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

Guest Blogger: Greg Weilersbacher
Founder & President, Eastlake Quality Consulting

All companies outsource. It’s a humbling fact that you simply can’t do it all yourself. This often has to do with resource allocation; your company may allocate dollars to build and sustain some activities in-house while choosing to contract higher-cost operations to qualified suppliers who already have the expertise and equipment. 

You may outsource the manufacturing of tablets, sterile injectable, or topical dosage form, or the GMP release and stability testing of your product. Once the production and testing is complete, the product may need to be stored under controlled temperature and humidity conditions and then distributed to locations around the globe. The Contract Development and Management Organizations (CDMOs) who execute these critical operations are of paramount importance to your company’s success. Choosing the right suppliers will also help to minimize stress-induced headaches throughout your organization. Here are the top five ways to get the most out of a supplier audit.



1.  Come to the Audit Prepared
This seems obvious. However, more often than not, quality auditors step into the supplier’s lobby without doing their homework. Ask yourself the following questions: Why am I auditing this supplier? Is this supplier new to my company or one that we have used before? If used previously, have I read over the audit observations as well as the supplier’s responses and do I understand them? Which audit observations do I suspect would be the most challenging for the supplier to address and which are most important to my company’s requirements for this product? Have I reviewed previously executed production batch records and testing data and are there issues that need to be resolved? Are their deviations and CAPAs to follow up on?

Your understanding the supplier’s work proposal is of great value in refining the scope of the audit. Ask yourself:  Which of our products may be manufactured and tested here and which strengths (e.g., potency) will be produced? Which equipment is likely to be used? For a tablet production, the equipment train could include balances, blenders, roller compactor, spray dryer, solvent-rated oven, comils, tablet press and tooling, gravity feeder, coating systems, de-duster, weight sorter, metal detector, tablet counter, etc. This list of equipment will assist you in requesting equipment records during the audit. 

2.  Stay On Point
Proper audit planning will help to keep the audit organized and adhere to the audit timeline. In advance of the audit, provide the audit host with a list of the technical, lab, and manufacturing staff you wish to speak with and the records you need to review. A well-organized host will have this available for your review. Stick to your audit agenda. This is critical. The best way to derail your progress is to spend precious time chasing down minor issues while glaring problems get little to no attention. Continually refer back to the audit agenda and remember to keep the content of your audit report in mind while executing the audit.


3.  Know Your Technical Expertise and Limitations
Many auditors have led previous lives in the laboratory or in manufacturing while others started their careers in quality assurance and may have little technical background with regard to equipment, manufacturing processes, GMP utilities and laboratory testing. Know your limitations and if necessary strengthen them by hiring an expert consultant to assist you during the audit.

A common problem area that is at best glossed over and at worst completely ignored during an audit is the CDMO’s compliance with GMP utilities requirements. All too often, this is due to the auditor’s lack of understanding of the operation, inputs and outputs, validation parameters, and periodic testing and maintenance requirements for utilities such as HVAC, clean or pure steam, purified water and WFI systems, autoclaves, clean compressed air, nitrogen and other gases used for operating equipment or used during processing activities in manufacturing. Typically, these areas are also less well understood by the CDMO’s employees and as a result noncompliance abound. 

Some GMP utilities may be connected to the facility’s building management system, while others may be stand-alone equipment. In either case, the CDMO should have records of alarms (e.g., out of specification or out of range conditions), an acknowledgement of each alarm by designated staff members, and documentation of corrective actions. The last item is key. This is where the execution of quality systems tends to fail. Make a point to request documentation of corrective actions for each utility alarm. 

Additionally, purified and WFI water systems along with gases, such as clean compressed air and nitrogen, require periodical sampling/testing at each point-of-use. Verify that the timelines (monthly, quarterly, or annual) for sampling and testing were performed as directed by the CDMO’s procedures. These timelines are typically not well adhered to. A clear understanding of all the operations of the supplier’s GMP utility management process will keep your thoughts clear during the audit and help identify areas that are in need of improvement. 

4.  The Auditor’s Job is to Identify the Good and the Bad (Not to Win the Debate)
An important goal of a supplier audit is to identify the supplier’s strengths and weaknesses and come away from the audit with a compliance assessment that your company can use to make important decisions. It is of no value to your company if the goal of the auditor is to show the supplier how much he or she knows by debating the fine points of compliance. GMP auditors with decades of experience generally avoid this competitive exchange as it is unproductive. Rather, it is more important to the spend the necessary time identifying compliance issues, making them known to the audit host in a professional manner, and taking detailed notes that assist in writing the audit report. Your company’s senior managers need to know the supplier’s good and not-so-good points; detailing all of these provides the greatest value. 

5.  Interview the CDMO's Lab Staff, Manufacturing Operators, and Shipping/Receiving Personnel
CDMO’s quality systems are generally written by managers and directors who have many years of industry experience. It is of utmost importance that staff members who execute these systems understand them if your company’s product is to be manufactured, tested, stored, and distributed in a compliant manner. Request to speak with manufacturing staff members who work on the production floor and are likely to work on your product. Ask them about the process they would follow to conduct lines clearance, charge powders to a blender, operate a spray dryer, use a comil, set-up of a tablet press, inspect tablets, use metal detectors, etc. Compare the information they provide to the CDMO’s SOPs to determine if the staff understands their jobs. Listen for phrases such as “I usually do it this way…” or “it’s a different every time but I typically set up the equipment like this…” These phrases reveal a lack of control and adherence to procedures. 

The Take Away
The audit itself lays the foundation for a relationship with the supplier and the take-away message should address the following questions: Will the supplier work to resolve the issues I’ve identified? Am I confident that the supplier will immediately notify and involve my company’s representatives when deviations occur during production or testing? Do the supplier’s quality systems and records meet my company’s requirements and those of regulatory agencies? How confident am I that the supplier will produce and/or test a quality product that my company can stand behind? Is the supplier simply a pair of hands or are they committed to be my partner in this product’s success? The answers will provide you with a comfort level in making the decision to move forward with the CDMO or to look to the their competition.  

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A version of this article was first published in Outsourced Pharma.

 About the Author
Greg Weilersbacher is the Founder and President of Eastlake Quality Consulting, a GMP consulting firm based in the Southern California area. Over the last 25 years, he has held director and vice president positions leading Quality Assurance, Quality Control, Analytical Chemistry, Materials Management, GMP Facilities, and Product Manufacturing in biotech and pharmaceutical companies. His unique experiences and technical background have led to the manufacture and release of hundreds of solid oral, sterile, and biologic investigational products to clinics in the U.S. and abroad. Email Greg at weilersbacher.greg@gmail.com.

Guangping Gao, the head of the Horae Gene Therapy Center at the University of Massachusetts Medical School, will partner with Philadelphia-based Spark Therapeutics to figure out better ways to get disease-curing genes into cells. The collaboration, announced this morning, gives Spark (Nasdaq: ONCE) the option for an exclusive, world-wide license for any intellectual property to come out of it. No financial terms were disclosed. Earlier this year, Gao was featured in Newsweek magazine for seemingly…

On Friday, 21 emerging medical device companies will present their technologies and business plans to a group of local investors at the annual MedTech Showcase, hosted by the Massachusetts Medical Device Industry Council. More than 300 venture leaders and business leaders are expected to attend the event tomorrow, Oct. 28 from 8 a.m. to 2 p.m. at the Westin Waltham, 70 Third Ave. As a main event, John McDonough, president and CEO of Lexington-based T2 Biosystems (Nasdaq: TTOO), will be interviewed…

• Independent Data Monitoring Committee recommended continuing ongoing Phase 3 trial only in the more advanced “critical” group with Kevzara higher-dose versus placebo and discontinuing less advanced “severe” group

The Alliance met (virtually) on April 15 with Dr. Caitlin Boon, FDA Associate Commissioner for Food Policy and Response and several of her colleagues. She described CFSAN’s and CVM’s role in responding to the current pandemic, as well as how the agency is assuring a continued safe food supply. About 50% of food spending in the […]

In response to written questions submitted last month regarding the potential for delays, FDA had stated that “CDER remains fully capable to continue daily activities, while responding to the public needs of the current COVID-19 outbreak.” In a subsequent blog … Continue reading →

by Derek Willis

In an April report that warns of the risks of fraud in mail-in voting, a conservative legal group significantly inflated a key statistic, a ProPublica analysis found. The Public Interest Legal Foundation reported that more than 1 million ballots sent out to voters in 2018 were returned as undeliverable. Taken at face value, that would represent a 91% increase over the number of undeliverable mail ballots in 2016, a sign that a vote-by-mail system would be a “catastrophe” for elections, the group argued.

However, after ProPublica provided evidence to PILF that it had in fact doubled the official government numbers, the organization corrected its figure. The number of undeliverable mail ballots dropped slightly from 2016 to 2018.

The PILF report said that one in five mail ballots issued between 2012 and 2018, a total of 28.3 million, were not returned by voters and were “missing,” which, according to the organization, creates an opportunity for fraud. In a May 1 tweet that included a link to coverage of the report, President Donald Trump wrote: “Don’t allow RIGGED ELECTIONS.”

PILF regularly sues state and local election officials to force them to purge some voters from registration rolls, including those it claims have duplicate registrations from another state or who are dead. It is headed by J. Christian Adams, a former Justice Department attorney who was a member of the Trump administration’s disbanded commission on election integrity.

The report describes as “missing” all mail ballots that were delivered to a valid address but not returned to be counted. In a statement accompanying the report, Adams said that unaccounted-for ballots “represent 28 million opportunities for someone to cheat.” In particular, the organization argues that the number of unreturned ballots would grow if more states adopt voting by mail.

Experts who study voting and use the same data PILF used in the report, which is from the Election Administration and Voting Survey produced by the federal Election Assistance Commission, say that it’s wrong to describe unreturned ballots as missing.

“Election officials ‘know’ what happened to those ballots,” said Paul Gronke, a professor at Reed College, who is the director of the Early Voting Information Center, a research group based there. “They were received by eligible citizens and not filled out. Where are they now? Most likely, in landfills,” Gronke said by email.

A recent RealClear Politics article based on the PILF report suggested that an increase in voting by mail this year could make the kind of fraud uncovered in North Carolina’s 9th Congressional District in 2018 more likely. In that case, a political consultant to a Republican candidate was indicted on charges of absentee ballot fraud for overseeing a paid ballot collection operation. “The potential to affect elections by chasing down unused mail-in ballots and make sure they get counted — using methods that may or may not be legal — is great,” the article argues.

PILF’s report was mentioned in other news outlets including the Grand Junction Sentinel in Colorado, “PBS NewsHour” and the New York Post. The Washington Times repeated the inaccurate claim of 1 million undeliverable mail ballots.

In a statement, the National Vote at Home Institute, an advocacy group, challenged the characterization of the 28.3 million ballots as missing. Of those ballots, 12 million were mailed by election officials in Colorado, Oregon and Washington, which by law send a mail-in ballot to every registered voter, roughly 30% of which are not returned for any given election. “Conflating voters choosing not to cast their ballots with ‘missing’ ballots is a fundamental flaw,” the statement reads.

In an interview, Logan Churchwell, the communications director for PILF, acknowledged the error in the number of undelivered ballots, but defended the report’s conclusions, saying that it showed potential vulnerabilities in the voting system. “Election officials send these ballots out in the mail, and for them to say ‘I have no idea what happened after that’ speaks more to the investments they haven’t made to track them,” he said in a telephone interview.

But 36 states have adopted processes where voters and local officials can track the status of mail ballots through delivery, much like they can track packages delivered to a home. Churchwell said there are other explanations why mail ballots are not returned and that state and local election officials could report more information about the status of mail ballots. “If you know a ballot got to a house, you can credibly say that ballot’s status is not unknown,” he said.

The EAVS data has been published after every general election since 2004, although not every local jurisdiction provides complete responses to its questions.

In the data, election officials are asked to provide the number of mail ballots sent to voters, the number returned to be counted and the number of ballots returned as undeliverable by the U.S. Postal Service, which provides specific ballot-tracking services. The survey also asks for the number of ballots that are turned in or invalidated by voters who chose to cast their ballots in person. It asks officials to report the number of ballots that do not fit into any of those categories, or are “otherwise unable to be tracked by your office.”

Gronke described the last category as “a placeholder for elections officials to put numbers so that the whole column adds up,” and said that there was no evidence to support calling those ballots a pathway to large-scale voter fraud.

Numerous academic studies have shown that cases of voter fraud are extremely rare, although they do occur, and that fraud in mail voting seems to occur more often than with in-person voting.

Supplies of certain drugs used when intubating patients with COVID-19 will run out “over the coming days”, the government has warned.

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Pharmacies dispensed approximately 35% more prescriptions in March 2020, compared with the previous month, according to a survey by the National Pharmacy Association.

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Supplies of the selective serotonin reuptake inhibitor, sertraline, are returning to stock after manufacturers reported “industry-wide” supply challenges, exacerbated by export bans and border closures implemented as a result of COVID-19. 

To read the whole article click on the headline

All the most important developments in the COVID-19 pandemic for pharmacists and their teams, as they happen.

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Wholesalers have “almost completely run out” of the personal protective equipment supplied by Public Health England for distribution to community pharmacies during the COVID-19 pandemic, the wholesaler trade body has warned.

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