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...the Food and Drug Administration gave the okay to a field trial that would release genetically modified Zika-killing mosquitoes in the Florida Keys...the FDA released a final environmental assessment of the trial, finding that it “will not have significant impacts on the environment.” The project, led by Oxitec, a biotech company that focuses on insect control, calls for the release of thousands of genetically engineered male Aedes aegypti mosquitoes. The lab insects are bred so that over time they could kill off much of the local mosquito population by passing on a gene fatal to any offspring they have with wild females...The FDA’s okay is a major step forward toward a U.S. implementation of the technology at a time of much concern over the spread of Zika in the U.S. after cases in Florida...

The pharmaceutical industry may be losing a heated battle over drug prices in California...A poll released earlier this week found that two-thirds of Californians support an initiative that would require drug makers to offers discounts to state health programs…At issue is the California Drug Price Relief Act (Proposition 61), which would revise state law to require the state Medicaid program, which is known as Medi-Cal, and other state programs to pay no more for medicines than the prices negotiated by the US Department of Veterans Affairs. Currently, the VA gets a 24 percent discount off average manufacturer prices...The measure is being closely watched as a litmus test for public discontent over prescription drug costs and the extent to which such efforts may crop up in other states, a point of great importance to drug makers. So far, the only state where a similar initiative is being organized is Ohio...California is often seen as a bellwether state for political trends and voter attitudes...

When EU regulators last year came down on China’s Jinan Jinda Pharmaceutical for slipshod manufacturing work, the company brought in a U.S. consultant to get its Zhangqiu, Shandong, plant in order. But a recent follow-up found that Jinan Jinda continues to ship its antibiotic to some European customers even though its improvement efforts fall short of what they need to be...the European Directorate for the Quality of Medicines said it has been recommended that Jinan Jinda's nitrofurantoin antibiotic be banned from the EU and that the plant's certificate of compliance be suspended, or even "voided."...The investigators reported that there were critical deficiencies in the way the plant handled raw data safety, control and out-of-specification reviews. There were major deficiencies in training, change control, quality assessment, process and cleaning validations.

Pfizer’s Bextra (valdecoxib) has not been on the market in more than a decade, but the litigation tied to it and pain drug Celebrex (celecoxib) continues to play out. The New York drugmaker has now put to rest a long-running class action by Pfizer shareholders who said a controversy over the drugs’ safety whacked the stock price and cost them a lot of money...Pfizer last week reached an agreement-in-principle to resolve the securities class action case for all defendants...the resolution is pending court approval and the terms are confidential until a formal agreement has been approved...The pain drugs made Pfizer a lot of money, at one time being among the company’s best-selling meds. But the controversy over their risks has also cost it tremendously. In 2009, Pfizer agreed to hand over $2.3 billion to settle a Department of Justice probe into its marketing of Bextra...And last year, the drugmaker settled another related investor suit for $400 million.

Cate Douglass, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Jazz Pharmaceuticals has been called out repeatedly for substantial price hikes on its leading product Xyrem. But now, the company’s cash cow could be in trouble...the...drugmaker saw four patents on its most important asset upturned by the U.S. Patent and Trademark Office, through the inter partes review system pharma has come to dread. The PTO is due to rule on two more "imminently,"...and given their similarity to those already tossed, they could well suffer the same fate...The patent loss is a blow to...Jazz, whose narcolepsy star generates more than 70% of its operating profit...The med has grown to that point somewhat controversially, as Jazz hiked its list price 841% over the 5 years ending in 2013.

Drug abuse, including misuse of prescription drugs, remains at alarmingly high levels...Feeding this epidemic, the National Association of Boards of Pharmacy says, are rogue Internet drug outlets illegally dispensing prescription controlled substances...illicit online drug sellers "hiding behind sleek websites" are making it easier for people struggling with drug abuse to purchase controlled-substance medications. However, since these rogue websites often sell counterfeit and tainted substances, buyers can raise the risk of overdose and death...researchers used popular search engines (Google, Bing and Yahoo), shopping websites (eBay, Craigslist, Yahoo! Shopping, Overstock.com, Etsy, Oodle, eCRATER, Bonanza, Sell.com, Blujay and Alibaba) and social media sites (YouTube and Twitter) to gauge the availability of the opioids Demerol, Dilaudid, Duragesic, Exalgo, Kadian, Lorcet, Lortab, Percocet, Roxicet, Vicodin and Zohydro. Opioids were easiest to find and readily available by using search engines, the researchers discovered. Still, no matter which online avenue was used, researchers found that the final destination was a dedicated website selling opioids illegally.

Drug, biologic and biosimilar companies’ comments on Food and Drug Administration draft guidance on biosimilar labeling reveals a major split between those who do and do not want a statement on a biosimilar’s interchangeability status on each new product's label...FDA has still yet to release its guidance on what interchangeability means, and as FDA has not found any biosimilar to be interchangeable with its reference product…

• Amgen says it...believes a biosimilar label should include a summary of the clinical data, including immunogenicity data, used to demonstrate biosimilarity or interchangeability…
• Pfizer said...biosimilars should not be labeled "as though they were small molecule generic drugs" and that it "recommends that biosimilar labeling include a statement reflecting whether interchangeability has been assessed."
• Merck & Co...says "that a single blanket approach applicable to all biosimilar products is not appropriate, and may cause unnecessary confusion among stakeholders."...recommends that rather than using such blanket statements, FDA take a risk-based approach for each biosimilar…
• Boehringer Ingelheim says that it "does not agree that a biosimilar label needs to include a ‘biosimilarity statement,’...Such information is not ‘essential scientific information needed by health care practitioners for the safe and effective use of a drug.’
• Sandoz...says... "It is self-evident that the very act of highlighting the indications that are extrapolated is being proposed by some groups in order to raise doubts as to the safety and efficacy of the biosimilar for those indications, and perhaps to also imply inferiority of biosimilars across the board.

On February 1, 2016, the Centers for Medicare & Medicaid Services released its Final Rule interpreting the provisions of the 2010 health care reform law that address the Medicaid Drug Rebate Program. While much of the Final Rule speaks to drug manufacturer rights and responsibilities in the MDRP, significant portions are directly applicable to chain drug stores...the Final Rule addresses (a) reimbursement for multisource drugs dispensed to Medicaid patients, (b) changes in the Average Manufacturer Price (AMP) that will impact pharmacy reimbursement for multisource products, (c) reimbursement for single-source drugs dispensed to Medicaid patients and (d) changes to the dispensing fees pharmacies will receive for dispensing drugs to Medicaid patients...An overarching theme expressed in the Final Rule is CMS’ desire to move states away from their historic practice of overpaying for ingredient cost while simultaneously underpaying for dispensing fees...If the Final Rule plays out as anticipated, in the coming year ingredient cost reimbursement will fall for single- and multiple-source products, but dispensing fees will rise...This reflects a desired shift away from a "spread-based" model of pharmacy Medicaid participation toward a "service-based" model. It’s currently unclear if the increased fee income to pharmacies will balance the lost reimbursement revenue.

• Multisource product ingredient cost reimbursement
• Changes in AMP affecting multisource drug reimbursement
• Single-source product ingredient cost reimbursement
• Medicaid pharmacy dispensing fees

An awareness campaign to improve public recognition of sepsis will be launched across the UK this year, carried out by the Department of Health and Public Health England...Working in collaboration with the UK Sepsis Trust, the initiative aims to better public understanding of the blood poisoning condition that requires quick diagnosis and treatment to effectively combat...Approximately 150,000 adults and children in the UK are affected by sepsis annually, with around 44,000 of those dying each year. If not identified and treated quickly, survivors of sepsis can be left with life-changing disabilities... better sepsis care could save 13,500 lives every year and save the NHS £314m annually...The public awareness drive - called Just ASK: could it be sepsis? - hopes to equip the general public with knowledge of the condition so that they might recognise it and prompt healthcare professionals to fast-track diagnosis of the time-sensitive illness.