- China’s Zhejiang Huahai lambasted in FDA warning letter for putting profits ahead of safety (fiercepharma.com)
The Chinese API maker at the heart of a global scare and recall of blood pressure medicines has been savaged in an FDA warning letter for failing to uncover a suspected carcinogen in its APIs when a customer complained several years ago...The FDA said that when Zhejiang Huahai Pharmaceutical altered its manufacturing process in 2011 to include a solvent suspected of producing the impurity, it didn’t even consider that the changes might lead to the formation of mutagenic impurities in its valsartan APIs...“You failed to adequately assess the potential formation of mutagenic impurities when you implemented the new process,” the highly redacted warning letter says...Regulators in the U.S. and Europe continue to test products to try to ferret out all of the affected drugs. The FDA says there is very little risk of the impurities causing problems, and no adverse reactions have been seen...
- Pat-INFORMED: the solution to drug patent procurement issues? (pharmaceutical-technology.com)
Many countries do not have the equivalent to the US’s Orange book, meaning that health officials are wasting time establishing whether patents have been taken out on medicines. Leading biopharmaceutical companies have worked together to develop Pat-INFORMED, a new global platform that could allow government procurement agencies to access information on thousands of individual patents anywhere in the world...Although information on patents is already in the public domain...its technical nature, or the fact that it is presented differently according to national varying requirements, prevents people from understanding what they are about...pharmaceutical companies have been thinking about how to overcome this challenge; many have been disclosing patent information for decades, but there has been no consistent approach for doing so. By way of a solution, the recently established Patent Information Initiative for Medicines (Pat-INFORMED) aims to make it easier for international drug procurement agencies to access a library of clear and understandable patent information...the main purpose of Pat-INFORMED is to help government health agencies and NGOs responsible for procuring medicines to assess the patent status of medicines, as it discloses the patents relating to the active ingredient. The platform includes a channel for procurement agencies to get in touch with the patent holders, so they can speak directly to experts in the relevant company...
- Marijuana Dispensary count could nearly double after state issues 61 conditional licenses, but details on winners remains secret (thenevadaindependent.com)Nevada Supreme Court: Pot dispensary owner names not public record (rgj.com)
Nevada could soon have almost twice as many marijuana dispensaries as it does now after the state issued 61 conditional licenses, although it’s not releasing details about who the winners of the potentially lucrative permits are...“We issued a number of state-level licenses in counties that have thus far declined to allow marijuana establishments,” said spokeswoman Stephanie Klapstein of the Nevada Department of Taxation, which regulates marijuana. “There’s a chance some of those licenses will not ultimately result in operational retail marijuana stores.”...License winners have one year to obtain local approvals and pass a final inspection from the tax agency before they are issued a final state license. At that point, the name of the dispensary will be published on the state list of open retail stores, which currently includes 65 dispensaries in five counties.
- December 7 Pharmacy Week in Review: Rural Health Care Workers Work Toward Policy Change, FDA Approves Treatment for Ocular Pain After Surgery (pharmacytimes.com)
Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- Is China the next great hope for the pharma industry? (pharmaceutical-technology.com)
Many top pharma firms have been forced to drop prices to get a slice of the Chinese market, but that hasn’t dampened spirits one bit – on the contrary, CEOs from companies like AstraZeneca and Pfizer have been celebrating dramatic Chinese sales increases in 2018. So how is China’s pharmaceutical market growing and is it really a clean bill of health for any internationals lining up to profit?...In pharmaceuticals specifically, China is comfortably the second-largest national market in the world, with healthcare analytics firm Iqvia putting its value at $122.6bn in 2017 and projecting growth to as much as $175bn by 2022...Multinational pharma firms are starting to make China a major priority for drug sales, as the potential for profit is now widely seen as a decisive counterbalance against the risks of operating under the Chinese regime...So what does China mean to the international pharma industry, and what opportunities and challenges are drug manufacturers encountering as they attempt to crack this lucrative market?
- Demographic changes bring opportunities
- Foreign firms are making big bets on China
- Regulatory reform opens China to foreign innovators
- Chinese competition and policy uncertainty remain a challenge
- Drug Maker Pays $360 Million to Settle Investigation Into Charity Kickbacks (nytimes.com)
The drug maker Actelion Pharmaceuticals has agreed to a $360 million settlement stemming from an investigation into whether the company illegally funneled kickbacks through a patient-assistance charity...Actelion...makes expensive drugs to treat a rare lung condition, is the latest pharmaceutical company to settle federal inquiries into their ties to patient-assistance groups, including whether companies have used the patient programs to increase the price of their drugs...But federal anti-kickback laws prohibit companies from giving such financial assistance to Medicare and Medicaid beneficiaries because doing so is considered an inducement to buy their drugs. For years, drug makers have skirted those laws by instead donating to nonprofit charities, which then give the money to Medicare patients. Such arrangements are legal as long as there is no direct coordination between the pharmaceutical company and the nonprofit organization...Federal prosecutors said Actelion violated the law by collecting detailed data in 2014 and 2015 about the patients receiving help from a nonprofit, the Caring Voice Coalition, and using the data to budget for future donations. As a result, Actelion ensured that the money it donated would be used only to assist patients who used its drugs, and not competing companies’ treatments for the pulmonary condition.
- Walgreens, FedEx partner on next-day Rx delivery nationwide (drugstorenews.com)
Walgreens and FedEx are teaming up...The companies have launched Walgreens Express, a service that will provide next-day delivery nationwide, as well as same-day delivery in select markets...Patients who are enrolled in Walgreens text alerts will get a text message notification when their qualifying prescriptions are ready. They can then follow a process to choose to have their prescription delivered the next day for a $4.99 fee...Walgreens said most prescription orders are available to be delivered by the next business day, it said some prescription benefit plans and insurance plans do not allow home delivery, encouraging patients to talk to a pharmacist with any questions.
- FDA issues draft guidance to ensure safety of compounded drugs (drugstorenews.com)
Today we’re updating some of our proposed policies related to these outsourcing facilities. Among our goals is to make it more feasible for compounding pharmacies to become outsourcing facilities...ottlieb said the FDA’s aim for this guidance is to recognize the differences in drug production between outsourcing facilities and conventional drug manufacturers. The guidance is intended to provide clarity on quality assurance, maintaining suitable facilities, sterility, stability testing, and beyond-use or expiration dates for products that don’t go through the FDA drug approval process...This revised draft guidance includes...revisions related to release testing, stability testing and beyond-use dating, as well as policies that differentiate between the production of sterile and non-sterile drug products...
- Six Michigan Doctors Charged in $464 Million Insurance and Opioid Scheme (nytimes.com)
Six Michigan doctors have been charged with insurance fraud and unnecessarily prescribing opioids to patients in a $464 million scheme, according to court documents...The 56-count indictment...named Dr. Rajendra Bothra...who owned and operated the Pain Center USA in Warren and Eastpointe, Mich., and the Interventional Pain Center in Warren. The other five doctors were employed by the clinics, which catered to patients with joint and spinal injuries...The doctors have been charged with submitting false claims...and diverting the proceeds to themselves...Prosecutors said the doctors submitted claims of $182.5 million to Medicare, $272.6 million to Medicaid and $9.2 million to Blue Cross Blue Shield of Michigan...
- No-deal Brexit disruption at UK ports could last up to six months – minister (reuters.com)
A no-deal Brexit could cause up to six months of disruption at some ports, a British minister warned...vowing to prioritise pharmaceuticals as the UK develops contingency plans less than four months before it is due to leave the EU...Health minister Matt Hancock wrote to drugs companies in August to ensure they had at least six weeks’ worth of medicines in Britain but on Friday he suggested any potential disruption could last longer...Britain is planning to use aeroplanes and fast-track trucks to ensure the continued supply of medicines if it leaves the European Union without a deal, Hancock said, and will give preference to medicines in the face of competing pressures.