- Families target Philippine officials and Sanofi executives with request for criminal charges (fiercepharma.com)
The Dengvaxia debacle in the Philippines just keeps heating up, as more than 70 mothers with vaccinated children filed for criminal prosecution against former officials, including ex-President Benigno Aquino III, and Sanofi executives...In their legal complaint, which asks prosecutors to consider criminal charges, the families targeted Aquino, former Department of Health chief Janette Garin, M.D., and two other government officials, as well as five Sanofi executives including CEO Olivier Brandicourt and Asia-Pacific head Thomas Triomphe...Invoking the country’s Anti-Graft and Corrupt Practices Act, the families claim that the government officials are “guilty of gross inexcusable negligence” for rolling out the program without due diligence...adding that they gave “excessive accommodations” to the global drug giant. The families also questioned “whether [Aquino] acted in conspiracy with Sanofi officials” in purchasing about $70 million worth of Dengvaxia doses...after Sanofi released results from a new analysis indicating that its vaccine could cause more serious infections if given to those who haven't previously encountered dengue. The country immediately stopped its mass vaccination program, and government officials took a tough tone with the company
- The next big thing in pharmacy supply chain: Blockchain (healthcareitnews.com)
With $200 billion lost to counterfeit drugs annually and patient safety issues, a chain-of-custody log that blockchain could enable holds promise...Blockchain has the potential to transform healthcare in general and the pharmacy supply chain in particular...The distributed ledger technology could offer legislative, logistical and patient safety benefits for pharmaceutical supply chain management. From a regulatory perspective in the United States, blockchain technological and structural capabilities, in fact, extraordinarily map to the key requirements of the Drug Supply Chain Security Act...The DSCSA outlines a 10-year timeframe that will require elements including medication track-and-trace, product verification and notification of stakeholders about illegitimate drugs. A shared ledger of information to enable each of these steps is a foundational aspect of blockchain technology...“Logistically, blockchain aligns well with federal efforts like the National Strategy for Global Chain Security,”...“One of the most promising benefits of blockchain from a patient safety perspective is to help stem the tide of the so-called SSFFC medicines – substandard, spurious, falsely labeled, falsified and counterfeit – that continue to plague the pharmaceutical supply chain.”
- From hackers to hurricanes, new threats loom for pharma supply chains in 2018 (fiercepharma.com)
Disasters, both natural and manmade, wreaked havoc on pharma supply chains this year, exposing vulnerabilities and costing the industry hundreds of millions, if not billions, of dollars...Hurricanes took out power and plants in Puerto Rico...Less visible but much more sinister was the cyberattack that managed to penetrate systems at Merck & Co...Experts say both kind of threats are only going to get worse...Some natural disasters, like earthquakes, don’t follow seasons and can’t be tracked. They just happen...The FDA pointed out that the Federal Food, Drug, and Cosmetic Act, does not include a specific provision giving the agency the authority to require a contingency plan for preventing drug shortages if a facility goes offline, regardless of the cause...Some events have nothing to do with weather or geography. Merck was the only drugmaker to publicly acknowledge that it had not adequately protected its computer systems and was a victim of the Petya cyberattack...Expect this trend to continue in 2018...the disruption caused by ransomware to industrial organizations in 2017 didn’t directly affect the automation controllers, “we expect that a new, more damaging type of ransomware will specifically target controllers” in 2018...if those threats were not enough to keep pharma executives up at night...the chilling observation that North Korea, “has quietly developed a cyber army capable of unleashing attacks against critical infrastructures that could have global implications.”
- Harnessing hospital pharmacists: Smarter spending will improve lives (shpa.org.au)
The twin goals of improving health outcomes and generating economic savings can be achieved by ensuring more people take prescribed medicines as intended, and pharmacy services are extended to more Australians, the Society of Hospital Pharmacists of Australia said today...SHPA’s Federal Budget 2018-19 Submission details policy measures to boost medicines compliance – particularly among people at high risk of non-adherence and hospital readmission, and patients taking high cost PBS medicines (Pharmaceutical Benefits Scheme)...SHPA recommendations for the 2018-19 Federal Budget
- Support compliance and maximise return on investment in high cost PBS medicines.
- Reduce harm caused by opioid use initiated in hospitals
- Bridge the gap for high-risk patients leaving hospital and returning to care in the community.
- Provide additional funding to support seven-day clinical pharmacy services in hospitals in the National Health Funding Reform Agreements for Public Hospitals beyond 2020.
- Address safety and quality concerns in aged care by embedding pharmacists in Commonwealth facilities and home nursing services.
- Improve antimicrobial stewardship in all Australian healthcare facilities to address the threat of antimicrobial resistance.
- Fund hospitals to provide Closing the Gap Pharmaceutical Benefits Scheme Measure subsidies to Indigenous people.
- Develop a national pharmacy workforce reform strategy.
- FDA Proposes Crackdown on Risky Homeopathic Drugs (ptcommunity.com)
The FDA is proposing a new risk-based enforcement approach to homeopathic drug products. Among the targets: products marketed for serious diseases without showing clinical benefits, products that contain potentially harmful ingredients, and products that don’t meet current good manufacturing practices...homeopathic drug products are subject to the same requirements related to approval, adulteration, and misbranding as any other drug product. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the agency’s enforcement policies since 1988...“In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer,” said FDA Commissioner Scott Gottlieb...“In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse—that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren’t adequately tested or disclosed to patients...The FDA intends to focus its enforcement authorities on the following kinds of products:
- Products with reported safety concerns
- Products that contain or claim to contain ingredients associated with potentially significant safety concerns
- Products for routes of administration other than oral and topical
- Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions
- Products for vulnerable populations
- Products that do not meet standards of quality, strength, or purity as required under the law
- Kmart to pay $32.3M to settle health care-related whistleblower case (nbcnews.com)
Kmart Corp. has agreed to pay $32.3 million to settle a whistleblower lawsuit alleging its pharmacies overcharged federal health care programs and some private insurers for generic prescription drugs..."Pharmacies that are not fully transparent about drug pricing can cause federal health programs to overpay for prescription drugs," Chad Readler, the acting assistant attorney general of the department's Civil Division, said..."This settlement should put pharmacies on notice that there will be consequences if they attempt to improperly increase payments from taxpayer-funded health programs by masking the true prices that they charge the general public for the same drugs."...The complaint was filed on behalf of former Kmart pharmacist James Garbe. According to the suit, in one case, Kmart had sold a 30-day supply of a generic version of a prescription drug for $5 to customers of its discount program, but then filed for reimbursement from the government for $152 for that same drug for its Medicare customers...Garbe will receive a whistleblower award of $9.3 million, which amounts to 29 percent of the federal government's recovery...
- Pharmacy Week in Review: December 22, 2017 (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.
- 2017 was a big year for FDA digital health regulations (healthcareitnews.com)
With a new administrator at the helm, the U.S. Food and Drug Administration took steps toward regulating decision support, software-as-a-medical-device, mobile tech in clinical trials and more...the FDA had a full plate in 2017 as it sought to revise its regulatory processes for the shifting healthcare landscape...the new guard already had announced and implemented a firm-focused pre-certification program, released new guidances addressing provisions of 2016's 21st Century Cures Act, and outlined a handful of other ongoing initiatives that are sure to impact the digital health industry. Here's a rundown of the agency's actions and announcements during 2017.
- New leadership, new approaches
...a plan that included clear language on which devices the agency would look to regulate, an app regulation strategy involving postmarket data collection, and other idea designed to streamline the approval process...FDA opened up applications for a pilot of a firm-focused digital health pre-certification program...nine companies selected to participate: Apple, Samsung, Verily, Pear Therapeutics, Tidepool, Phosphorus, Fitbit, Roche, and Johnson & Johnson...draft of the long-awaited and somewhat controversial guidance on clinical decision support, which laid out the forms of clinical decision support that would or wouldn't be regulated based on the degree of human involvement (as opposed to risk)...draft guidance describing the FDA's new Breakthrough Devices Program...would supersede the Expedited Access Pathway and aims to push novel technologies presenting a significant improvement over status quo through the clearance process more quickly.
- FDA shifts toward digital, patient feedback
...the Clinical Trials Transformation Initiative – a public-private partnership of pharma companies, academics, and regulators including the FDA – released new endpoint recommendations for the use of mobile technologies in clinical trials... The guidelines, meant to be the first in a series of such documents, included suggestions for study designers when selecting novel endpoints, practical approaches when developing these endpoints...
- New leadership, new approaches
- This Week in Managed Care: December 22, 2017 (ajmc.com)
Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- Teva CEO tells PM no bending on mass redundancy plan (ynetnews.com)Teva workers: 'We'll stop distributing drugs for serious diseases' (ynetnews.com)
Despite personal attempts by Netanyahu and government ministers to persuade pharmaceuticals giant's chief to reduce number of planned layoffs, Kåre Schultz doubles down, insisting any compromise will only result in 'further redundancies and the closure of more factories,' notes program represents a ‘small part’ of cost slashing spree around the world...Prime Minister Benjamin Netanyahu failed to convince...Teva CEO Kåre Schultz to reduce the number of Israeli layoffs he intends to execute in the pharmaceuticals giant in a plan that has sparked outrage and triggered multiple protests.