Monday, December 18, 2017

Barry Sherman's death stuns Apotex at a difficult time

The Globe and Mail-11 hours ago
Power also continues to concentrate in Canada with grocer Metro Inc. recently buying pharmacy chain Jean Coutu, following McKesson's acquisition of Rexall and ... Mr. Gal recently calculated that the price for the top 20 U.S. generic drugs has fallen at a compound annual growth rate of negative 8.5 per cent from the first ...

CVS-Aetna Merger Will Influence Employers' Benefits Decisions: Aon

Insurance Journal-8 hours ago
CVS Corp.'s proposed purchase of Aetna Inc. will affect decision-making by a majority of large and mid-size U.S. corporations on employee health benefits, a survey by benefits consultant Aon Plc found. CVS, the second-largest U.S. pharmacy benefit manager, on Dec. 3 said it agreed to buy No. 3 health insurer Aetna for ...

Amazon Hasn't Figured Out Drugstores Yet. But It Will Have To

Bloomberg-1 hour ago
For months now, pharmacy and health benefits companies have fretted that they're the next targets of Jeff Bezos's disruption steamroller. In September Amazon.com Inc. acquired Whole Foods Market, a grocery chain that could theoretically add drug counters to stores; a month later came word that the e-commerce giant ...

Former presidents of pharmacist watchdog received questionable ...

Toronto Star-3 hours ago
It's illegal in Ontario for drug companies to give cash or incentives to induce a pharmacy to stock their products. These unlawful payments are known as rebates and critics say they compromise pharmacists' professional independence and can artificially inflate the price of generic prescriptions. The money from M

Sunday, December 17, 2017

In Opioid Battle, Cherokee Want Their Day in Tribal Court

New York Times-20 hours ago
The Cherokee suit argues that the pharmacy chains Walmart, Walgreens and CVS Health, as well as the giant drug distributors McKesson, Cardinal Health and AmerisourceBergen, flouted federal drug-monitoring laws and allowed prescription opioids to pour into the Cherokee territory at some of the highest rates in the ...

President of Winnipeg-based Canada Drugs has licence to practice ...

CBC.ca-2 hours ago
The president of Canada Drugs, the Winnipeg-based online pharmacy accused of selling misbranded and counterfeit drugs in the United States, has had his licence to practice pharmacy in Manitoba suspended. The College of Pharmacists of Manitoba informed pharmacy managers of the immediate suspension of Kristjan ..

Audit: NH drug monitoring program a mess

WCAX-5 hours ago
CONCORD, N.H. (AP) A new audit finds that New Hampshire is falling short of its efforts to keep tabs on opioid prescription patterns. The Concord Monitor reports that a legislative audit finds the state's Prescription Drug Monitoring Program has been poorly managed by the Board of Pharmacy since its creation in 2012.

Hot Topic!! High Importance!! Whistleblowers: DEA attorneys went easy on McKesson...."Investigations ‘We feel like our system was hijacked’: DEA agents say a huge opioid case ended in a whimper"

Whistleblowers: DEA attorneys went easy on McKesson, the ...

CBS News-1 hour ago
David Schiller: The issue with McKesson was they were providing millions and millions and millions of pills to countless pharmacies throughout the United States, and they did not maintain any sort of due diligence. This wasn't just happening in Denver, Colorado. This was happening in Los Angeles, California.

Pharmacy council calls for tough measures against illegal pharmacies

The New Times-1 hour ago
The National Pharmacy Council has called for a crackdown on illegal and substandard pharmacies which it says sell substandard pharmaceutical products. The call was made during the council's 6th general assembly and conference held under the theme "Pharmacy ethics, laws and professionalism," in Kigali on Friday.

Saturday, December 16, 2017

Teva Pharmaceuticals to Cut 25% of Jobs in Huge Reshaping

New York Times-Dec 14, 2017
Teva Pharmaceuticals, the world's biggest maker of generic drugs, said on Thursday that it would cut about a quarter of its work force, or 14,000 jobs, close manufacturing and research facilities and suspend its dividend as it seeks to simplify its structure and reduce its debt. The Israeli company has faced management ...

Canadian police probe mysterious deaths of billionaire pharma couple

Reuters-8 hours ago
A police forensics photographer works outside the home of billionaire founder of Canadian pharmaceutical firm Apotex Inc., Barry Sherman and his wife Honey, who were found dead under circumstances that police described as "suspicious," in Toronto, Ontario, Canada December 16, 2017. REUTERS/Chris Helgren ...

Canadian police probe 'suspicious' deaths of billionaire couple

South Florida's kratom cocktail bars may see herbal drug outlawed

Friday, December 15, 2017

Dietary Supplement & Cosmetics Legal Bulletin | December 2017

JD Supra (press release)-Dec 13, 2017
The U.S. International Trade Commission (ITC) has reportedly declined to investigate a complaint filed by Amarin Pharma Inc. that alleged 18 companies falsely categorize unapproved new drugs containing omega-3 acids as dietary supplements. The complaint alleged that false labeling allows the companies to avoid .

Putin says whitsleblower was under US control

Lewiston Morning Tribune-19 hours ago
Russian officials have previously said they accept some drug use occurred, but on a much smaller scale than alleged, and that Rodchenkov tricked some clean Russian athletes into taking banned substances by claiming they were legitimate dietary supplements. Putin also reiterated previous claims that Russian doping ...

Congressmen Commend FDA's Increased Priority of Dietary ...

Natural Products INSIDER (blog)-6 hours ago
Because of the high number of Americans who consume at least one dietarysupplement per day—approximately half of the population—the lawmakers praised FDA for having documentation of products contaminated with unsafe ingredients. These products violate the 1994 Dietary Supplement Health and Education Act

Putin accuses US of manipulating doping testimony | SunStar

Sun.Star-14 hours ago
RUSSIAN President Vladimir Putin accused U.S. agencies of manipulating evidence from the main whistleblower on doping at the 2014 Sochi Olympics. Putin said Thursday that former Moscow anti-doping laboratory director Grigory Rodchenkov — who is under witness protection after fleeing to the United States last year ...

Express Scripts Closes Acquisition Of eviCore; Companies Unite To ...

Markets Insider-7 hours ago
They don't differentiate between medical and pharmacy services or expense, and neither should we," said Tim Wentworth, President and CEO of Express Scripts. "Joining forces with eviCore accelerates our shift toward holistic patient benefit management. It allows us, in partnership with health plans and payers, to target ...

Few California pharmacists prescribing birth control

Reuters-8 hours ago
(Reuters Health) - A California law allowing pharmacists to prescribe birth control sought to make it easier for women to obtain contraception, but few drug stores provide the service, a new study finds. Only 11 percent of retailers in the state offered pharmacist-prescribed contraception one year after the law went into effect, .

Tentative plea deal reached for Winnipeg-based pharmacy accused ...

CBC.ca-7 hours ago
A tentative plea agreement has been reached that would see a Winnipeg-based online pharmacy and two affiliated businesses fined millions of dollars for selling misbranded and counterfeit drugs in the United States. U.S. court documents filed on Dec. 12 show the agreement, which still has to be approved by a U.S. district ...

DaVita pharmacy unit to pay $63.7M to settle billing claims

Modesto Bee-Dec 14, 2017
pharmacy services unit of dialysis provider DaVita Inc. has agreed to pay $63.7 million to resolve allegations that it improperly billed federal health care programs and paid illegal financial inducements to patients. The Denver Post reports that the U.S. Department of Justice announced the settlement on Thursday, which

How pharmacy companies game the Medicare system

Redding Record Searchlight-7 hours ago
My experience tells me that anyone taking a lot of drugs needs to be very aggressive about using the Medicare website, as well as considering Canadian pharmacy outlets and sites such as GoodRx.com to get discounted prices. In some cases it's actually cheaper to pay full price for the medicine rather than take the ...

Pharmacy exec in 2012 meningitis outbreak wins restitution delay

Reuters-4 hours ago
A federal judge has put off the issue of whether a Massachusetts pharmacy executive should pay victims of a deadly 2012 meningitis outbreak $73.7 million in restitution until after the latter's criminal appeal is decided. Over prosecutors' objections, U.S. District Judge Richard Stearns in Boston on Thursday agreed w

Nebraska news outlets ask to join lawsuit over release of information ...

Lincoln Journal Star-6 hours ago
The drugs purchased are diazepam, fentanyl citrate, cisatracurium besylate and potassium chloride. But the Corrections Department has not made public its supplier of those drugs or whether they came from a known drug manufacturer or compounding pharmacy. The department did say they were purchased in the United ...

What's Coming in 2018: FDA's Regulatory Agenda

Regulatory Focus-14 hours ago
The US Food and Drug Administration (FDA) published its fall 2017 agenda of proposed and final rulemakings this week, with several expected on drug compounding, allowing foreign clinical data to bring medical devices to market and new ways to market nonprescription drugs. On the compoundingfront, FDA plans to ...

What's Coming in 2018: FDA's Regulatory Agenda

Regulatory Focus-14 hours ago
The US Food and Drug Administration (FDA) published its fall 2017 agenda of proposed and final rulemakings this week, with several expected on drug compounding, allowing foreign clinical data to bring medical devices to market and new ways to market nonprescription drugs. On the compoundingfront, FDA plans to ...

Thursday, December 14, 2017

Looking ahead: Some of FDA’s major policy goals for 2018 Posted on December 14, 2017 by FDA Voice By: Scott Gottlieb, M.D.--Compounding is included

Looking ahead: Some of FDA’s major policy goals for 2018

By: Scott Gottlieb, M.D.
Twice a year the federal government publishes the “Unified Agenda of Federal Regulatory and Deregulatory Actions” (Unified Agenda), which provides the American public with insight into regulations under development or review throughout the federal government. For the U.S. Food and Drug Administration (FDA), it gives us an opportunity to outline some of our efforts to modernize our approach to our work and improve our efficiency, while fulfilling our mandate to protect and promote the public health and uphold FDA’s gold standard for regulatory decision-making. While many of FDA’s polices are advanced through guidance documents and other proposals, this annual list of proposed regulations provides one element of our policy agenda.
Patients and consumers across our country depend on us to regulate products in a predictable, efficient, science-based manner. We also serve the public health by efficiently advancing innovations and therapies that improve patient care, enhance choice and provide competition; by aggressively taking action against serious threats to public health, such as opioid addiction and addiction to the nicotine in cigarettes; by empowering patients, consumers and healthcare providers with accurate and up-to-date information; and by recognizing when scientific innovations warrant new, more flexible regulatory approaches in order to make sure advances in care can reach patients. In addition to these goals, we must continually adapt our regulations to enhance efficiency, improve our effectiveness, and update old and out-of-date requirements.
FDA’s contributions to the Fall 2017 Unified Agenda address a number of these areas of policymaking underway at the agency, and are directly aligned with our key priorities:
Addressing the Nicotine Addiction Crisis
To reduce the morbidity and mortality associated with combusting tobacco, we are proposing meaningful actions to advance our new, comprehensive approach to nicotine and the regulation of combustible cigarettes. These efforts include an Advance Notice of Proposed Rulemaking asking critical questions related to our pursuit of regulation that would result in a targeted reduction of the nicotine levels in combustible cigarettes to eliminate or dramatically reduce their addictive value. At the same time, FDA is taking new steps to facilitate innovation in products that can deliver satisfying levels of nicotine to adults who want or need such access without the same health risks associated with combustible tobacco.
As part of this plan, FDA will also be issuing an Advanced Notice of Proposed Rulemaking to look at how to best regulate flavors in tobacco products to limit their appeal to youth, while considering the potential role that some flavors may play in helping users transition away from combustible products. Further, FDA will be issuing an Advance Notice of Proposed Rulemaking to solicit information that may inform regulatory actions FDA might take with respect to premium cigars, asking certain questions related to how we might define and regulate “premium cigars,” taking into consideration the health effects of these products and their patterns of use.
Advancing Drug Safety
FDA will issue several regulations on drug compounding to help ensure the quality of medicines that patients need. We want to make sure that outsourcing facilities clearly understand which drugs they may compound and allow these firms to adopt more efficient, streamlined manufacturing standards, while ensuring they observe necessary safety and quality measures.
Focusing on the safety of prescription drugs, FDA is also pursuing a proposed rule to establish national standards for the licensing of prescription drug wholesale distributors and third-party logistics providers, as part of track-and-trace requirements. By establishing national standards for all State and Federal licenses issued to key parts of the supply chain, these regulations will allow for the effective and efficient distribution of prescription drugs throughout the U.S.
Promoting Food Safety
FDA continues to take steps to improve its oversight of food safety. To address critical issues related to the overall safety of the food we eat, FDA intends to propose a rule on lab accreditation, which would establish a program to accredit labs to do food safety testing and to require that these accredited labs be used in certain situations.
Additionally, in the Unified Agenda, FDA committed to pursuing a rulemaking that will clarify registration requirements for food facilities to better align how facilities and farms that perform similar activities are treated under the preventive controls rules and the produce safety rule.
Empowering Consumers
Many of our agenda submissions are part of a broader effort to empower consumers and patients to make more informed and effective health decisions and ensure they have appropriate autonomy over their choices, while continuing to ensure the products they consume and use are safe and effective. Consumers tell us that they want this information. We also know that consumers who have access to more diverse, safe and effective options – and who have improved information about those choices – make better, more cost-effective decisions. 
  • Providing Better Information on Drugs: We have included a rulemaking that proposes a new type of patient medication document that would help ensure that patients have access to clear, concise, and useful written information about their prescription drugs or biologics, delivered in a consistent and easily understood format, each time they receive a medication from the pharmacy. We want to give patients the ability to make high value decisions about the medicines they take, and help them use drugs safely and effectively.
  • Broadening Access to Nonprescription Drugs: We are considering innovative action in the nonprescription drug area to expand the scope of drug products that can be made available to consumers without a prescription. We will be proposing to allow certain innovative approaches for demonstrating that a drug product can be used safely and effectively in a nonprescription setting. This will allow some drugs that would otherwise require a prescription to be marketed without a prescription through the use of innovative technologies and other conditions that will ensure appropriate self-selection and/or appropriate actual use of the nonprescription drug product by consumers. Examples of such conditions could include use of self-selection questions on a mobile medical app prior to permitting access to the drug, or other innovative technologies to improve safety. Through use of these types of additional conditions, we hope to create a new paradigm of drug safety with greater flexibility that will benefit patients and public health. We are committed to advancing this new framework to enable a potentially broader selection of nonprescription products for consumers, empowering them to self-treat more common conditions and chronic conditions. This also could help lower costs by increasing the availability of products that would otherwise be available only by prescription.
Modernizing Standards
Importantly, we also are working to ensure efficiency of existing regulations – a key focus of the Unified Agenda – by making sure that our standards are clearly defined, that they advance our public health goals and help promote the protection of consumers, and achieve these goals in an efficient way that does not place unnecessary burdens on those we regulate. We also want to ensure that our standards and regulations are modern and reflect the latest science, and have not become outdated, obsolete or otherwise not applicable to the current environment.
  • Harmonizing Global Standards: We will be updating FDA’s requirements for accepting foreign clinical data used to bring new medical devices to market. While helping to ensure the quality and integrity of clinical trial data and the protection of study participants, this rule should also reduce the burden on industry because it will harmonize with the standards currently used in drug regulation.
  • Modernizing Mammography Standards: We will be proposing a rule to modernize mammography quality standards that will improve women’s health. Our aim is to recognize advances in technology and help to ensure women get the most relevant, up-to-date information about their breast density, which is now recognized as a risk factor for breast cancer. This information can help doctors and patients make more informed choices about how to interpret the results of tests, and what treatment options to pursue.
  • Embracing Electronic Submissions: We will propose a new framework that will allow FDA and product developers to take greater advantage of the efficiency of electronic, rather than paper, submissions for devices and veterinary drugs.
  • Removing Outdated Rules: We will propose to remove an outdated inspection provision for biologics and outdated drug sterilization requirements to remove barriers to the use of certain sterilization techniques.
Looking to the Future
FDA serves Americans by delivering on the critical mission of protecting and promoting the public health. The more than 70 actions we have identified, as part of the Fall 2017 Unified Agenda, will help us even better deliver on this mission. But regulation is only one way in which we can foster our mission and improve American health.
Over the next year, we will also tackle many additional priority areas through guidance documents and other policy efforts. These areas will include efforts to reduce the cost of drugs by encouraging competition, spur innovation across medical products, give consumers access to clear and consistent nutrition information, create greater regulatory efficiencies in bringing products to market, and put a dent in the opioid addiction crisis facing our country.
Further, just because a previously identified regulation does not appear on this Unified Agenda submission does not necessarily mean the agency does not consider it a priority or will not continue to consider it moving forward. Look for additional information about the many initiatives identified in the Fall 2017 Unified Agenda as we advance all of these goals.
Scott Gottlieb, M.D., is Commissioner of the U.S. Food and Drug Administration
Follow Commissioner Gottlieb on Twitter @SGottliebFDA
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FDA Warning Wire: Chocolate 'Snuff' Sold As Street Drug Sub
Law360, New York (December 12, 2017, 6:27 PM EST) -- The U.S. Food and Drug Administration took a bite out of the marketers and distributors of a chocolate “snuff” for peddling the pow

Compounding pharmacy exec, wife earned $72M from companies before meningitis outbreak The Tennessean

Tech execs guilty of conspiring to fill nursing home prescriptions with ...

McKnight's Long Term Care News-13 hours ago
A subsidiary of a pharmacy chain near Pittsburgh pleaded guilty Tuesday in a conspiracy scheme described by prosecutors as an attempt to recycle unused medications. Soo C. Song, acting U.S. attorney for the Western District of Pennsylvania, announced Iserve Technologies Inc. will pay $1.55 million to reimburse the ...

Niagara Falls pharmacist, charged with asking customers to disrobe ...

Buffalo News-2 hours ago
6, in exchange for surrendering his state pharmacist's license. Kendzia was arrested in late July on one woman's complaint, but Assistant District Attorney Peter M. Wydysh said other customers came forward later with similar stories. Wydysh said Kendzia claimed he was looking for track marks to make sure the customers ...

Former pharmacist gets plea deal in coercion case

Lockport Union-Sun & Journal-14 hours ago
James Neiss/photographerThis file photo from 2011 shows Robert Kendzia at work inside MacLeod's Pharmacy on Buffalo Avenue. Kendzia recently agreed to give up his pharmacist's license under a deal with prosecutors that would allow his coercion case to be adjourned in contemplation of dismissal within six months ...

Congress told: pharmacy distribution reform severely needed

McKnight's Long Term Care News-13 hours ago
The president and CEO of the Senior Care Pharmacy Coalition warned the House Energy and Commerce Health Subcommittee on Wednesday that pharmacy benefits managers are bad for business, for both consumers and the federal government. "Pharmacy benefit managers harm competition and are today exacting ...

Pharmacy exec in 2012 meningitis outbreak seeks restitution delay

Reuters-17 hours ago
A Massachusetts pharmacy executive found guilty of racketeering for his role in a deadly 2012 meningitis outbreak is seeking to delay until after his appeal prosecutors' ... Lawyers for Barry Cadden, the co-founder and former president of the now-defunct New England Compounding Center, in papers filed on Wednesday in ...

Another Guilty Plea In The Compounding Pharmacy Investigation In ...

www.mondaq.com/.../Another+Guilty+Plea+In+The+Compounding+Pharmacy+Inves...
2 hours ago - Timothy Frazer, a commercial construction estimator, admitted his role in a $50 million health care fraud conspiracy in New Jersey. United States Food, Drugs, Healthcare, Life Sciences Day Pitney LLP 14 Dec 2017.

Senate Committee Evaluates Impact of Cures Act on Mental Health, Opioids Some Senators say opioid funding hasn't been fairly dispersed

Wednesday, December 13, 2017

Speculation continues surrounding Amazon, UPS, and pharmacy

Pharmacy Today, American Pharmacists Association, pharmacist.com-Dec 12, 2017
On October 27, 2017, the St. Louis Post-Dispatch reported that Amazon had received approval from 12 state boards of pharmacy for wholesale pharmacy licenses. The article has fueled media speculation about Amazon potentially entering the pharmacy market, but a spokesperson for Amazon told Pharmacy Today, “We ...