- FDA Warns Wockhardt for Destroying CGMP Documents, Other Violations (raps.org)
...Indian drug manufacturer Wockhardt is in trouble again with the US Food and Drug Administration, this time for destroying current good manufacturing practice documents, among a list of other major violations...FDA sent a warning letter to the company following an eight-day inspection...of its Ankleshwar...manufacturing site that uncovered “torn and shredded equipment maintenance documents, raw material labels, and change control work orders” in the site’s scrap yard awaiting incineration...The site was banned from shipping products to the US in August...This is the latest in a series of failures by Wockhardt to meet the standards of not just FDA but other regulators...
- Healthcare fraud: A look back at a pivotal year (fiercehealthcare.com)
From a healthcare fraud enforcement perspective, 2016 was nothing short of a dynamic year...It was punctuated by the arrival of several important trends within the addiction treatment, post-acute care and compound pharmaceutical industries…It also featured a Supreme Court ruling on a False Claims Act legal theory, and a changing enforcement landscape in the aftermath of the Yates memo...As 2016 comes to a close, let's look back at some of the fraud trends that emerged—or in some cases intensified—over the last 12 months.
- Impact of the Yates memo
- Government targets post-acute care providers
- Big healthcare fraud busts continue
- Compound pharmacies under fire
- OxyContin marketing concerns revisited
- Addiction treatment gains ground, raises concerns
- Data continues to influence fraud detection
- EpiPen price hikes lead to overpayment settlement
- Medicare Advantage overbilling resurgence
- Supreme Court rules on implied certification
- Collins, McCaskill Release Committee Report of Bipartisan Drug Pricing Investigation (aging.senate.gov)Senator Susan Collins...Chairman... of the Senate Aging Committee, released a report on drug pricing...titled, “Sudden Price Spikes in Off-Patent Prescription Drugs: The Monopoly Business Model that Harms Patients, Taxpayers, and the U.S. Health Care System.” The comprehensive report details the findings stemming from the Committee’s bipartisan investigation into abrupt and dramatic price increases for prescription drugs whose patents expired long ago. Through close examination of the monopoly business model used by four pharmaceutical companies to exploit market failures, the report examines how companies acquired decades-old, off-patent, and previously affordable drugs and then raised the prices suddenly and astronomically at the expense of patients. The report provides case studies of the four companies; explores the influence of investors; assesses the impacts of price hikes on patients, payers, providers, hospitals, and the government; and discusses potential policy responses.
- Enact the Increasing Competition in Pharmaceuticals Act...to incentivize competition to address regulatory uncertainty, small market size, and other factors that serve as limitations to generic entry;
- Encourage generic competition by ensuring the right to obtain samples and simplifying Risk Evaluation and Mitigation Strategies;
- Consider allowing highly targeted, temporary prescription drug importation to provide prompt price relief for major price increases in off-patent drugs;
- Take steps to prevent the misuse of patient assistance programs and copay coupons;
- Reinvigorate the Federal Trade Commission to take greater enforcement action on drug company mergers, operations, and drug market dynamics; and
- Improve transparency in the health care system.
- New precision medicine tool helps optimize cancer treatment (worldpharmanews.com)
Columbia University Medical Center researchers have created a computational tool that can rapidly predict which genes are implicated in an individual's cancer and recommend treatments. It is among the most comprehensive tools of its kind, and the first that incorporates a user-friendly web interface that requires little knowledge of bioinformatics...The researchers found that iCAGES identified personal cancer "drivers" 77 percent of the time when presented with a pair of randomly chosen driver genes and non-driver genes, compared with about 51 percent for other computational tools... Cancer "drivers" can vary from patient to patient, and there are no practical clinical tools for predicting which variants in an individual's genome are driving his or her disease and which are present but not causing disease...Dr. Wang...developed a computational tool called integrated CAncer GEnome Score…(it) analyzes the patient's entire genome, comparing it to the genomic sequence of the patient's tumor to identify possible cancer-causing variants. Next...cross-references these variants to databases of known cancer-causing genes, using statistical analyses and machine learning techniques to prioritize the most likely driver genes. Finally...matches the variants to FDA-approved and experimental drug therapies that specifically address those variants or genes. The entire process takes about 30 minutes...
- Life-extending capacity of new cancer drugs varies widely (reuters.com)
Drugs recently approved around the world to fight cancer increased patients' overall survival, but benefits vary depending on the drug, a new study shows...Researchers looked at the 62 cancer drugs approved in the U.S. and Europe between 2003 and 2013 and found they extended survival by an average of about 3.5 months...a third of the drugs lacked evidence to suggest they increased survival when compared to alternative treatments...results point to the notion that new cancer treatments may not always provide patients with greater clinical benefits, or lower risks, over existing treatments...The risk-benefit ratio of new drugs is especially important if people are concerned, for example, about whether the cost of a drug would make it difficult for a person to complete the treatment regimen...
- Thousands of medical marijuana dispensary applications possibly leaked in Nevada (lasvegasnow.com)
The state of Nevada’s government website has potentially exposed the personal data on over 11,700 applicants for dispensing medical marijuana in the state...each application, eight pages in length, includes the person’s full name, home address, citizenship, and even their weight and height, race, and eye and hair color. The applications also include the applicant’s citizenship, their driving license number, and social security number...A Google search done by a man in Dallas led to the discovery of the problem. Justin Shafer said he discovered the breach Tuesday night while he was looking to see if any government websites had errantly posted social security numbers online. Shafer said he noticed one of the completed applications pop up in the search results with a social security number in plain view...Many of the people affected are employed by members of the Nevada Dispensary Association…Riana Durrett, executive director of Nevada Dispensary Association...says she's been assured the state is focusing all of its efforts to fix the breach...The state disabled the website...as a precaution...
- NICE and FDA join forces to improve medtech access (pharmaphorum.com)
The UK’s cost effectiveness body is to work with the US regulator to speed up patient access to medtech innovations...NICE’s Scientific Advice programme team and the FDA’s Payer Communication Taskforce are now looking at how best to help developers of medical devices, diagnostics and other medtech technologies gather the best evidence to demonstrate their product’s effectiveness...In their efforts to get a product to market, companies can get caught out...To win regulatory approval in the US, companies give the FDA data on the safety and efficacy of their devices. But although they often do enough to win FDA approval, they need additional evidence to prove to the organisations who would actually pay for those devices that they are cost-effective and clinically-effective...NICE and the FDA’s collaboration is the latest effort to help clarify the pathway that new medtech innovations have to navigate to reach patients
- Top 10 Focus stories from 2016 (pharmacist.com)In order, these are the stories that interested readers the most in 2016
- FDA announces major change in pharmacy inspections - In July, FDA issued a notice announcing that they are changing procedures for inspections of human drug compounders. FDA only gave about a month from the announcement—August 1—for the notice to be effective. APhA government affairs identified troubling language in the notice as follows: FDA will still undertake inspections of 503A facilities, rather than complying with current statute; FDA still intends to include CGMPs on Form FDA-483s, potentially for 503A pharmacies.
- New sleep recommendations for most age groups - Good sleep is a must. In March, the National Sleep Foundation revised all recommended sleep ranges, which are age-specific and based on a systematic review of the current scientific literature. Overall, wider appropriate sleep ranges for most age groups are recommended by NSF.
- CDC releases updated vaccine recommendations for 2016–17 influenza season - Updated vaccine recommendations for the 2016–17 influenza season included the continuation to have everyone aged 6 months and older without any contraindications receive a routine annual influenza vaccine. In addition, only injectable inactivated influenza vaccine and recombinant influenza vaccine should be used. In the recommendations, two new influenza vaccines were approved since last season and finally, a few of the recommendations for administering influenza vaccine in those with a history of egg allergy have been modified.
- Zika virus disease: Frequently asked questions for pharmacists and their patients - Zika virus disease was on everyone’s minds this year, including pharmacists. Here were some frequently asked questions from February as the disease was beginning to emerge.
- Newer antihistamines can cause adverse reactions in children - In a study published in the Archives of Disease in Childhood, Dutch researchers found that adverse reactions from second-generation antihistamines can occur in children—a finding that gave many pause since these second-generation antihistamines were developed in an attempt to decrease adverse effects from first-generation antihistamines.
- FDA: Antibacterial soaps should be avoided - In October, FDA put out a striking announcement to ban 19 active ingredients in antibacterial soaps and body washes, including triclosan and triclocarban—the two most commonly used ingredients. The reason: These active ingredients have little science to back up their effectiveness and could actually do more harm than good.
- New federal overtime rules likely to have implications for pharmacy residents - The Department of Labor issued a final rule that took effect on December 1. It stated that employers must increase minimum salary for certain employees to keep them exempt from wage regulations, such as those related to overtime pay. The final rule does not exempt pharmacy residents, meaning they could see a bigger paycheck going forward.
- FDA approves brand-name change for vortioxetine - FDA decided to change the brand name for vortioxetine. Starting in June, Brintillex switched its labeling to Trintellix in order to avoid errors associated with the similar-sounding name of the medication Brilinta.
- CDC issues health advisory on beginning of severe flu season - Back in February when flu season was just beginning to hit, CDC issued a health advisory stating that severe influenza illnesses were reported. They also took the opportunity to encourage clinicians to continue with efforts to vaccinate patients against the influenza virus.
- With Obama’s signature, expansive opioid policies become law - President Barack Obama signed legislation in July to provide a much-needed framework for opioid abuse prevention and treatment. The legislation, called the Comprehensive Addiction and Recovery Act of 2016, also recognized pharmacists as key players in the fight against the opioid epidemic.
- E.U. Agency in Limbo as Hidden Costs of ‘Brexit’ Continue to Mount (nytimes.com)
When it switched offices in London not long ago, the European Medicines Agency signed a 25-year lease on a shiny new building in the east of the city...Just two years later, the organization is preparing to relocate again, but this time its likely move has sent tremors through Britain’s pharmaceutical industry and raised fears over public safety...the European Medicines Agency...will almost certainly have to leave Britain, just one of the many unanticipated consequences of the vote that is forcing the country to unscramble 40 years of European integration...cities...are scrambling to lure its team of experts, who license drugs and monitor their use for safety...Most worrisome is an internal assessment suggesting that relocating the agency might mean losing up to half its personnel...With a full workload of applications in the pipeline, the organization is already close to the breaking point…If it loses more than 15 percent of its experts….the agency will probably not be able to maintain current schedules for licensing new drugs and monitoring existing ones...
- IV treatments, including for hangovers, a growing trend in Las Vegas amid criticism (reviewjournal.com)
New Year’s Day might be the time for looking ahead, but a headache from the night before can make that hard to do...Drip Doctors is hoping to help New Year’s revelers on the Las Vegas Strip boost their spirits and welcome 2017 in good health by running its mobile IV vitamin therapy unit on Sunday...The van, which will roam the Strip and travel to any off-Strip appointments, will provide intravenous nutrients to consumers suffering from issues such as hangovers and nausea...The business, which advertises its services as a quick way to improve overall energy, immunity and recovery from ailments including a headache or cold, has plans for two brick-and-mortar valley locations, one on Dean Martin Drive near the Rio and another at The District at Green Valley Ranch. Both are expected to open by March…IV vitamin therapy isn’t without controversy...Many facilities that offer such treatments are considered medical spas, which can have little to no direct state oversight in Nevada if they do not perform medical treatments...Critics of the therapy also say it’s unnecessary for most healthy people, overly expensive and a potential source of infection if done too often...