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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and beyond-use or expiration dates for products that don’t go through the FDA drug approval process...This revised draft guidance includes...revisions related to release testing, stability testing and beyond-use dating, as well as policies that differentiate between the production of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 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...

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.

As pharmacists continually build their scope of expertise, hospital anti-microbial stewardship programs are just one more avenue for putting their experience and knowledge to work...Anna Legreid Dopp, PharmD, director of clinical guidelines and quality improvement at ASHP, says pharmacists have a responsibility to take a prominent role in antimicrobial stewardship programs by

• Promoting the opial use of antimicrobial agents;
• Reducing the transmission of infections;
• Decreasing adverse events associated with antibiotic use; and
• Participating in formulary management and educating health professionals, patients, and the public.

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...

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.

Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

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.

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.

Pharmacy chain and benefits manager CVS Health Corp...said...it will offer a new prescription benefit option guaranteeing its health plan clients 100 percent of any rebates, discounts or other fees paid by drugmakers...The new plan model is aimed at providing greater drug cost simplicity, predictability and transparency...Under its new option, CVS takes on the risk of drug price inflation and shifts in drug use - at least for the term of each contract...The new model guarantees average spending per prescription across each distribution channel – retail, mail order and specialty pharmacy...