- US FDA track and trace: Industry welcomes data standardisation (in-pharmatechnologist.com)
The US Food and Drug Administration released the Standardization of Data and Documentation Practices for Product Tracing – guidance last week, which elaborates on industry standards relating to the Drug Supply Chain Security Act...(which) aims to build an electronic system to trace prescription medicines in the US...The move to fully electronic traceability information is a positive step in terms of data integrity, availability and exchange in the supply chain...It is important firms within the pharmaceutical supply chain move in the same direction and embrace the advantages of technology and digitisation... Moving to a completely electronic system should only bring advantages to CMOs and the wider industry, improving data integrity and security and reducing the time and resource needed to produce and exchange traceability...
- Kentucky could become the first state to tax opioid prescriptions (statnews.com)
Lawmakers in Kentucky are weighing whether to impose a new tax on opioid prescriptions, the latest effort in a string of so-far failed attempts to pull new revenue from the painkillers that helped seed a nationwide addiction crisis...The proposed tax — a 25-cent levy on drug distributors for every dose sent to the state — was approved by the Kentucky House...as part of a broader budget and tax plan. But unlike in other states, where lawmakers aimed to steer the new revenue to addiction treatment and education programs, the Kentucky plan...would direct the money to fill budget gaps elsewhere, including boosting funding for the state’s public schools...the Healthcare Distribution Alliance, which represents drug distributors, said that “if a regressive tax is imposed on any product, particularly a healthcare product, it will limit the ability for legitimate patients to access the medicines they require for the treatment of chronic pain or palliative care.”
- This Week in Managed Care: March 2, 2018 (ajmc.com)
Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- Why Your Pharmacist Can’t Tell You That $20 Prescription Could Cost Only $8 (nytimes.com)
...states across the country are moving to block “gag clauses” that prohibit pharmacists from telling customers that they could save money by paying cash for prescription drugs rather than using their health insurance...Many pharmacists have expressed frustration about such provisions in their contracts with the powerful companies that manage drug benefits for insurers and employers. The clauses force the pharmacists to remain silent...“the pharmacist cannot volunteer the fact that a medicine is less expensive if you pay the cash price and we don’t run it through your health plan.”...In North Dakota, a new law explicitly bans gag orders. It says that a pharmacy or pharmacist may provide information that “may include the cost and clinical efficacy of a more affordable alternative drug if one is available.”...also says that a pharmacy benefit manager or insurer may not charge a co-payment that exceeds the actual cost of a medication...the Pharmaceutical Care Management Association, has filed suit in federal court to block the North Dakota law, saying it imposes “onerous new restrictions on pharmacy benefit managers.”
- Shkreli Ordered by U.S. Judge to Forfeit Almost $7.4 Million (bloomberg.com)Shkreli Deserves at Least 15 Years in Jail for Fraud, U.S. Says (bloomberg.com)What Happens to Martin Shkreli's Wu-Tang Album Now (vice.com)'Pharma bro' Martin Shkreli launched 'unmonitored drug trial' in Cyprus for Retrophin drug without FDA oversight: Prosecutors (cnbc.com)
Martin Shkreli must turn over almost $7.4 million...a judge ruled in a win for prosecutors who say the hedge-fund manager turned pharmaceutical executive cheated his investors...The jailed convict is scheduled to be sentenced March 9 for lying to investors in his hedge funds about his track record and performance as well as a fraud that involved Retrophin Inc., a company he founded...Shkreli had argued that he shouldn’t have to forfeit anything -- or just over $500,000 at the most -- because he didn’t profit from the crimes. Money from his investors went into the stock market, and he didn’t get anything from a plan to control Retrophin shares...Investors ultimately got their money back...Shkreli’s assets -- a Picasso, $5 million in cash in a personal trading account, a one-of-a-kind special edition album by the Wu-Tang Clan, an unreleased Lil Wayne album and shares in Vyera Pharmaceuticals...can be used to fulfill the forfeiture if there’s not enough cash available...
- Twenty states sue the federal government, seeking an end to Obamacare (reuters.com)
A coalition of 20 states sued the federal government...over Obamacare, claiming the law was no longer constitutional after the repeal last year of its requirement that people have health insurance or pay a fine...Led by Texas Attorney General Ken Paxton and Wisconsin Attorney General Brad Schimel, the lawsuit said that without the individual mandate, which was eliminated as part of the Republican tax law...Obamacare was unlawful..."The U.S. Supreme Court already admitted that an individual mandate without a tax penalty is unconstitutional," Paxton said in a statement. "With no remaining legitimate basis for the law, it is time that Americans are finally free from the stranglehold of Obamacare, once and for all," ....
- Pharmacy Week in Review: March 2, 2018 (pharmacytimes.com)
Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- Why can’t the drug industry solve its gender diversity problem? (cen.acs.org)
Women and men enter the workforce with advanced degrees in medicine and science at nearly the same rate, but for some reason, many more women either drop out or hit a plateau in their careers...Whether it is the paucity of women on company boards, the slow progress in getting women into leadership positions at big pharma, or the alarming absence of women as scientific founders and research heads, the numbers just aren’t there...organizations have amped up the number of initiatives meant to help women ascend the ranks. Networking for women, board training for women, mentorships for women—programs have proliferated...But are they actually moving the needle on gender diversity in biotech?...To try to answer that question, C&EN talked with nearly two dozen women working in the biosciences—in academic drug discovery, biotech start-ups, and big pharma...Some are optimistic that women entering the workforce now will be the true beneficiaries of a society that values an inclusive work culture. Others worry that change is simply too slow or unfolding in a way that doesn’t get at the fundamental reasons so many women drop out of the pipeline...
- Doctor admits disclosing patient info to drugmaker Aegerion (reuters.com)
A Georgia pediatric cardiologist pleaded guilty...wrongfully disclosing information about his young patients to an Aegerion Pharmaceuticals Inc sales representative seeking to identify potential new users of an expensive cholesterol drug...Dr. Eduardo Montana...entered his plea in federal court...Montana pleaded guilty to a misdemeanor charge that he wrongfully disclosed patients’ individual identifiable health information. While he faces up to a year in prison, prosecutors have agreed to recommend a term of probation...According to prosecutors, after Aegerion in 2012 received regulatory approval to market Juxtapid for treating high cholesterol in adults with a rare genetic disease, the drugmaker promoted it for use by patients who lacked the condition...Montana...also disclosed information to a senior Aegerion executive promoting Juxtapid’s off-label uses and provided the sales representative the code to access his electronic medical record system...
- Big pharma, big data: why drugmakers want your health records (reuters.com)
Drugmakers are racing to scoop up patient health records and strike deals with technology companies as big data analytics start to unlock a trove of information about how medicines perform in the real world...Studying such real-world evidence offers manufacturers a powerful tool to prove the value of their drugs...Real-world evidence involves collecting data outside traditional randomized clinical trials, the current gold standard for judging medicines, and interest in the field is ballooning...The ability to capture the experience of real-world patients, who represent a wider sample of society than the relatively narrow selection enrolled into traditional trials, is increasingly useful as medicine becomes more personalized...It’s getting more expensive to do traditional clinical trial research, so industry is looking at ways it can achieve similar goals using routinely collected data...The thing that has made all this possible is the increasing digitization of health records...Food and Drug Administration...believes more widespread use of real-world evidence (RWE) could cut drug development costs and help doctors make better medical choices...Under the 21st Century Cures Act, the FDA has been directed to evaluate the expanded use of RWE...As the breadth and reliability of RWE increases, so do opportunities for FDA to also make use of this information...