Author: Peter

A bill under which the government would have gained responsibility for repurposing off-patent medicines showing promise in unlicensed indications has failed to make it past its second reading in parliament…The …is seeking to make the Secretary of State for Health responsible for securing new licences for unprotected medicines where there is evidence of their effectiveness in new indications…the Bill…could, over time, “revolutionise access to treatments across a whole range of medical conditions”, as currently, there is no incentive for pharmaceutical companies to seek new licenses for old drugs that are no longer patent protected, meaning that in cases where they could be effective against other diseases patients would only get access through off-label prescriptions…the government is instead pursuing a non-legislative solution to the issue of off-patent drugs…

Humana said it will discontinue several products offered on government-run exchanges under the Affordable Care Act, impacting about 100,000 individuals currently covered by the insurer’s plans across the country…The move, disclosed this morning in the company’s third-quarter earnings report, comes due to higher-than expected medical costs from sick newly insured patients covered under the health law…“Operating results for the company’s individual commercial medical business continue to be challenged primarily due to the volatility related to the start of the healthcare exchange program created under the Affordable Care Act as well as the morbidity of membership served under this relatively new program,”…The plans Humana will discontinue had “product designs which attracted a higher-utilizing member base than was assumed when the 2015 plan offerings were priced,” the company said but didn’t specify the kind of plans that will be pulled. “The transitory nature of the population served has also contributed to use of emergency room services and non-participating providers above priced-for levels.”

Following on from a presentation to the State Council earlier this week, China announced…it will launch a three-year pilot plan to speed up approvals for new drugs…China's Food and Drug Administration said...that the pilot plan will take place in 10 regions and will allow research organizations and researchers themselves to seek approval for new drugs rather than forcing them to transfer their findings to drug manufacturers who then would be allowed to produce the drugs and reap most of the benefits…Officials hope the change will spur innovation in pharmaceutical development...The move is also part of China's plans to reform its entire health care sector to ease crowded hospitals, souring relations between doctors and patients, corruption and high patient costs...

The pharmacy profession is in jeopardy if it does not respond to the immediate crisis of the understaffing of pharmacies, especially those affiliated with chain stores. This understaffing has become increasingly apparent with the recent injunction and monetary fine of $502,000 given to Walgreens for not providing consultation services…A leading cause of mortality is medication errors, 21% of which result from dispensing errors…reasons for errors…too many telephone calls, overload, too many patients, no one available to double-check, illegible/misinterpreted prescription, and staff shortage…Non-provision of consulting services also contributes to the issue of medication non-adherence. Only half of the 3.2 billion prescriptions dispensed in the United States are taken as prescribed. Approximately 125,000 deaths are linked to medication non-adherence annually…Despite multiple citations and fines imposed on chain pharmacies, and lawsuits brought on behalf of the general public, chain corporations still fail to counsel patients, and the result is a steady stream of medication errors.

…Supreme Court is weighing a request from Allergan to rule on whether drug companies can pull a medication from the market as generic competition looms in order to force patients to switch to new versions of the drug…The move, which may hinge on antitrust laws, will be closely watched by the pharmaceutical industry…. Allergan signaled plans to end sales of its twice-a-day Namenda IR tablet for Alzheimer’s disease. The drug maker wanted to pull its drug from the market several months before the patent on the medication was set to expire— and before it faced any competition from generics…plan was to push its newer, once-daily Namenda XR, which has patent protection until 2025.

Food and Drug Administration sent a warning letter to…gene testing company DNA4Life over its sale of an unapproved direct-to-consumer gene test to predict drug response…the agency said it was unable to identify any FDA clearance for the company's test. The letter follows 23andMe's limited relaunch last month of a series of direct-to-consumer tests after the agency ordered the tests off the market...

Chinese health officials shed some additional light on the country's plans to reform its healthcare system by saying they plan to implement a "multilevel" system for medical treatment, according to a press briefing…The plan for the new system is designed to relieve some of the stress that larger hospitals face from "too many patients seeking treatment in big hospitals,"…the new system would provide a tiered level where patients first go to "nearby community-level hospitals" which can then transfer patients to a higher-level hospital "depending on the severity of the situation."...The multilevel system is at odds with the "superhospitals" trend in China in which facilities feel the need to expand their services in the face of reforms that could cut their revenues, especially the recently enacted cut of the 15% markup in drug prices that hospitals were once allowed to charge.

Pfizer Chief Executive Ian Read, who has been lobbying Congress regularly for a corporate tax cut, is trying for the second time in as many years to do a deal with a foreign company that could produce the savings he has been unable to extract from Washington…Pfizer Inc, which is pursuing a deal for Dublin-based Allergan Plc, was one of the top spenders among pharmaceutical companies lobbying the…government…Pfizer spent $9.49 million on lobbying in 2014 and $10.1 million on lobbying in 2013…Pfizer appears to have stopped waiting for Congress to act."I don't think they are giving up, I think they are just dealing with the world as it is...Investment in cures and patients don't follow a political calendar, they follow a scientific calendar,"…

Thousands of pages of the final text of the 12-nation Trans-Pacific Partnership trade deal were released by the White House…in hopes of persuading critics to come out in favor of it. But those hopes were dashed when critics from all walks of the economy in the U.S. and elsewhere criticized the provisions…critics ranged from Ford to environmental groups to U.S. nurses and Malaysian officials concerned about potential cost increases on lifesaving drugs that will affect patients who could suffer when lower-cost generics take years longer to come on to the market…National Nurses United union said in a statement that the TPP "is even worse than prior reports had predicted" and said monopoly pricing protections for pharmaceutical companies "could be a death sentence for countless patients in need of affordable medications around the world."...

The ongoing debate over specialty drugs — reflecting conflicting motives of buyers and sellers — neglects important insights about the impact of these new technologies, their value to society, and the economics of medical R&D.  We here disentangle the facts from the myths surrounding these products…“Specialty drugs” is a term that has entered common vocabulary to categorize a class of drugs that are clinically unrelated, but are increasingly grouped together due to their high cost.  They have come under scrutiny lately from payers, policymakers, and physicians and exemplify the most significant, recurring challenge in modern health care:  how to balance effective innovation with fiscally viable pricing.  Unfortunately, solutions are elusive because of pervasive myths about these products...Below we debunk the most serious myths impeding an effective policy response..

• Myth:  Growth in Specialty Drug Spending Will Bankrupt Health Care
• Myth: Specialty Drugs Offer Only Incremental Value
• Myth: Profits from Specialty Drugs Sales are Excessive
• Myth: The U.S. Would Benefit from European-style Price Controls
• Myth:  High Prices are the Sole Source of Financial Hardship on Patients
• What’s the Bottom Line?