- China says vaccine maker Changsheng broke manufacturing rules, faked records: Xinhua (reuters.com)Arrests on the way at Changsheng Bio-tech, the company at the centre of Chinese vaccine scare (scmp.com)China widens vaccine scandal probe, vows tough penalties (reuters.com)
China’s cabinet investigation group has found that vaccine maker Changsheng Bio-technology broke the law in manufacturing rabies vaccines...The investigation group said the company had systematically falsified production and testing records to avoid regulatory scrutiny...“The company used expired materials to produce some rabies vaccine and falsified the production date,”...“To cover up violations, the company systematically fabricated production and testing records.”...China has launched sweeping spot checks on vaccine makers around the country after Changsheng was found to have falsified data and sold ineffective vaccines for children...President Xi Jinping has ordered all relevant departments to investigate the scandal, which has triggered public outrage in what is the latest case of tainted medical products...
- As Amazon Lurks, Walgreens Launches Digital Marketplace Listing Providers And Prices (forbes.com)
Walgreens Boots Alliance is launching a new digital marketplace that will connect the pharmacy chain's mobile visitors to its drugstores as well as local doctors and clinics...The move comes as Walgreens, CVS Health, Walmart and other brick-and-mortar retailers with health services face the possibility online retailer Amazon will expand deeper into the healthcare business...But Walgreens is stressing ties to local healthcare providers, which Amazon doesn’t yet have...Walgreens “Find Care Now” platform lists cash prices for healthcare services for everything from a local clinic or optometrist to the cost of a telehealth vendor’s virtual doctor consultation. For now, there are 16 local health systems and national healthcare providers participating in Find Care Now but Walgreens said they expect more to join the marketplace.
- EU drug regulators step up work to prepare for ‘no deal’ Brexit (reuters.com)
Drug regulators across Europe are hiring extra staff and increasing their workload as the role of British experts in the EU-wide system of medicines supervision winds down ahead of Brexit...Britain has already stopped taking on new projects that will extend beyond March 29, 2019 and is preparing to hand over existing drug review work to other countries...Despite a vote by UK members of parliament this week calling for Britain’s continued participation in the Europe regulatory network for medicines, there is no certainty that any such deal will be reached...That reflects the wider lack of clarity over Britain’s future relationship with the world’s biggest trading bloc after it leaves the EU next March...The Brexit-induced disruption also comes at a time when regulators are having to grapple with oversight of a range of new health technologies, such as gene therapy, and a slew of big data on health outcomes...Global drug companies, including UK-based GlaxoSmithKline and AstraZeneca, have been vocal in calling for continued close EU-UK ties after Brexit. The issue is also important to many Japanese drugmakers that have made Britain their European base.
- Doctors say pharmaceutical firms are top cause of high medical costs (healthcarefinancenews.com)
...high healthcare costs, most physicians claim they are not the ones to blame and instead pinpoint pharmaceutical and insurance companies, according to a new survey from University of Utah Health...members of the New England Journal of Medicine Catalyst Insights Council, who are clinicians, clinical leaders and executives involved with healthcare delivery...overwhelmingly believe pharmaceutical firms, followed closely by insurance companies, hospitals and health systems, have the biggest impact on costs...Other findings revealed by the survey showed that 86 percent believe physicians are not adequately trained to even discuss the cost of care, and 64 percent say there is not enough time to discuss the cost of treatments with patients. And 90 percent believe healthcare costs are too confusing for patients, while 78 percent feel the necessary tools are not available for patients to estimate those costs.
- Our bipartisan bill will force drug companies to justify ‘drastic’ price hikes (cnbc.com)
Drug companies are making record profits and at the same time raising the prices of life-saving prescription drugs...Additionally, drug companies have no legal obligation to justify or explain the massive spikes in drug prices...the FAIR Drug Pricing Act, a bill that takes the first step in addressing skyrocketing prescription drug prices by requiring basic transparency for pharmaceutical companies that drastically spike the price of a drug...whose initials stand for “Fair Accountability and Innovative Research," would require drug companies to give notice and justification for raising the price of a drug more than 10 percent at one time or more than 25 percent over three years...For each price increase drug companies would have to tell the public what they spent on manufacturing, research and development costs for the qualifying drug, net profits attributable to the qualifying drug, and marketing and advertising spending on the qualifying drug...
- Nevada to get quick state Supreme Court reply on execution (ktvn.com)Officials warn that expiring drugs means Dozier execution must take place before November (thenevadaindependent.com)
The Nevada Supreme Court has agreed to quickly take up the question of whether a drug company can block the use of its product in an inmate's execution...Prison officials won expedited review Friday, just minutes after filing documents saying the state faces the expiration of one of three drugs it wants to use...State Attorney General Adam Laxalt's office says it needs a high court ruling by Oct. 19...That would put twice-convicted killer Scott Raymond Dozier's twice-postponed lethal injection on track for mid-November...Dozier says he wants to die, but judges have for different reasons blocked the never-tried combination of drugs the state drew up after struggling to find lethal injection supplies...Pharmaceutical firm Alvogen says Nevada improperly obtained its sedative midazolam to use in Dozier's execution.
- Blood Pressure Medicine Is Recalled (nytimes.com)
The Food and Drug Administration has announced a voluntary recall of a widely prescribed blood pressure medication made in China, reviving fears about the safety of imported drugs...Three companies that sell the generic drug, valsartan, in the United States agreed to recall it after the F.D.A. said it might be tainted by N-nitrosodimethylamine (NDMA), considered a probable human carcinogen. The agency is still investigating, but said the contamination was believed to be related to changes in the way that valsartan was manufactured...All of the valsartan that is being recalled was made in China by the same company, Zhejiang Huahai Pharmaceutical Co. Ltd. It is distributed in the United States by three companies: Major Pharmaceuticals; Teva Pharmaceutical Industries, Ltd.; and Solco Healthcare... Other companies that market the drug, not subject to the recall, are Sun Pharma, Mylan, Jubiliant, Aurobindo and Hetero...The safety of imported drugs has long been debated. The F.D.A. said it would continue to investigate the levels of NDMA in the recalled products, determine the possible effect on patients who have been taking them, and assess what measures can be taken to reduce or eliminate the impurity from future batches...
- Viral content: vaccine scandal tests Beijing’s grip on information control (reuters.com)
A Chinese vaccine scandal has laid bare a new challenge Beijing faces in its long-running battle for information control: blogs and online articles by independent writers capable of unleashing a storm of public fury...The outrage over safety lapses by Changsheng Bio-technology Co Ltd in some of its vaccines for children came six days after the issue was flagged in regulatory filings, triggered instead by a July 21 article posted on the popular WeChat messaging platform...Titled “Vaccine King” and posted to a WeChat account managed by former journalists, it critiqued business practices by Changsheng’s chairwoman and was read tens of thousands of times before being deleted the next day...The enormous impact of the so-called “zi meiti”, or “self-media” article marks a threat to efforts by China’s ruling Communist Party to tighten its grip over content online...The article touched a nerve in a country already scarred by a long history of drug and food scandals. A day later Chinese social media was ablaze...For China, keeping a tight grip on the flow of information is seen as key to maintaining social stability in the world’s most populous nation...
- Swiss, German drugmakers join U.S. price freeze (reuters.com)
European drugmakers Roche, Bayer and Merck KGaA became the latest companies to freeze prices in the United States for the rest of 2018 following criticism by President Donald Trump over the cost of medicine...Roche did boost U.S. prices for nine key drugs by an average of 3 percent on July 1, but said it would hold off additional increases as discussions with the Trump administration continue over a longer-term solution to containing healthcare costs...The European announcements on Friday follow similar moves from Novartis, Pfizer and U.S. drugmaker Merck.
- Bowing to Trump, Novartis Joins Pfizer in Freezing Drug Prices (nytimes.com)
Novartis...said...it would not raise prices on its products in the United States for the rest of 2018, joining Pfizer, which delayed its increases last week after President Trump singled out the company for criticism...Novartis’s chief executive, Vas Narasimhan, said during an earnings call with investors that the company had made the decision in June, amid escalating outrage over high drug prices. “We thought that was prudent, given the dynamic environment we’re currently in,” he said...Pharmaceutical companies are scrambling to stem the groundswell of criticism over steep drug pricing, as elected officials and the Trump administration have taken up the issue...