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The 46 medicines given approval through 2017 as part of the Food and Drug Administration’s Breakthrough Therapy program have often been sent to patients without a large double-blind study, direct measurement of benefit, or comparison with a placebo or existing treatment, according to a new analysis...“FDA approval of these breakthrough therapies is generally based on shorter and smaller clinical trials than those that support FDA approval of non-breakthrough therapy drugs,” coauthor Dr. Joseph Ross....expediting drug approvals raises concerns that important safety or effectiveness information will be missed, potentially heightening risk of patient harm...The study, published in the Journal of the American Medical Association, did not examine whether the drugs were actually as effective and safe as pre-approval testing suggested. In some cases the FDA doesn’t require such post-marketing studies for “breakthrough” drugs...people, when they hear ‘breakthrough designation,’ assume the ‘breakthrough’ is based on great clinical trial evidence but it’s actually more of an expectation that this is promising...My expectation is that this is what the public and clinicians (and Congress!) wants - more novel therapies coming to market as quickly as is reasonably possible, while still assuring drug safety and efficacy...questions persist on whether a larger trial will produce a different result, whether the benefit will fade as treatment continues, whether a drug will prove to be dangerous over the long term and whether a drug will really make a difference in long-term quality of life or survival...

Industry groups like easier quality reporting and advance applications of telehealth, but some say docs shouldn't have to make expensive EHR upgrades for 2019..."historic changes" announced...by the Centers for Medicare & Medicaid Services, promising big adjustments to its policies around the Physician Fee Schedule and the Quality Payment Program, already have the healthcare industry talking...CMS says it wants to incentivize the use of and access to virtual care and telehealth, to ease the quality reporting burden on physicians by focusing on the most important and impactful measures...also wants to spur better information sharing among healthcare providers, regardless of what electronic health record vendor they happen to use...CMS notes that these proposals will modernize Medicare payment policies to promote access to virtual care, saving Medicare beneficiaries time and money while improving their access to high-quality services no matter where they live...the new proposal would "help shift the nation’s electronic documentation away from overly long, form-driven, hard-to-read documents written primarily to satisfy billing requirements to what it was originally intended for – providing high- quality care to patients."...

The Food and Drug Administration is advising consumers not to purchase or use Maximum Powerful, a product promoted for sexual enhancement that contains sildenafil, the active ingredient in Viagra. This product was identified during an examination of international mail shipments...The announcement is part of the agency’s effort to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. The culprit products are typically promoted for sexual enhancement, weight loss, and bodybuilding and are often represented as being “all natural.”...the FDA noted that it is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. As a result, the agency issued a blanket warning that consumers should exercise caution before purchasing any product touted as improving sexual enhancement, helping with weight loss, or building up muscle...

Pfizer’s decision to delay planned drug price hikes after President Trump attacked the company on Twitter may cause another shakeout throughout the health-care industry. Analysts at Goldman Sachs, Morgan Stanley and SunTrust expect other drugmakers will have to show more restraint on price increases, and say drug distributors may also find themselves under pressure. Height Capital Markets earlier cautioned about the risk to pharmacy-benefit managers, saying that Pfizer’s move ups the ante for the White House to propose policy changes on the use of rebates...“Drug stocks will not react favorably to this news, given the chilling effect this will likely have on others looking to take price increases. On the one hand, the price increases taken in July are only a small number of increases taken over the past year or several years, so the impact of the rollback to the healthcare system is insignificant in the big picture. However, the impact on the broader [dialogue] is much larger.”

The European Medicines Agency...published its first report on implementing its policy on the publication of clinical data whereby researchers, academics and others can access data from clinical reports submitted by pharmaceutical companies to EMA for new medicines as of 1 January 2015...The 27-page report covers one year from the launch of EMA’s clinical data website on 20 October 2016, and lists the 50 medicines for which clinical data were published...EMA is the only regulatory authority to provide open access to clinical data submitted by companies in support of their marketing authorisation applications...The report unveils the documents published, the amount of commercially confidential information redacted and the anonymization techniques used...EMA accepted about one third of CCI redactions proposed by pharmaceutical companies, though only 0.01% of 1.3 million pages published contained CCI redactions...anonymization techniques to protect personal data, the report suggests conducting a “proper assessment” of the impact of the anonymization technique on data utility and improving the quality of the anonymization reports...

Alvogen has won a court order preventing the Nevada Department of Corrections from using its sedative drug product, midazolam, in an execution...A temporary restraining order has blocked the Nevada Department of Corrections from using Alvogen’s midazolam in an execution due to take place yesterday (7/11). The drug was intended to be used as a sedative, prior to delivery of the lethal injections...Alvogen had claimed the Department fraudulently obtained the drug. “Alvogen does not accept direct orders from prison systems or departments of correction,”...“Alvogen also works with its distributors and wholesalers to restrict any sale, either directly or indirectly, of our midazolam product to any prison system or department of corrections,”...Alvogen “does not condone the use of any of its drug products, including midazolam, for use in state sponsored executions,”...

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 FDA will consider creating a list of “essential drugs” and financial incentives to drugmakers that manufacture them as it continues to grapple with the drug shortages that plague U.S. hospitals and caregivers...FDA Commissioner Scott Gottlieb, M.D...announced the formation of a new Drug Shortages Task Force and named Keagan Lenihan, the FDA’s associate commissioner for strategic initiatives to lead it...“I’m charging the shortages task force to delve more deeply into the reasons why some shortages remain a persistent challenge,” Gottlieb said. “The charge to this new task force is to look for holistic solutions to addressing the underlying causes for these shortages.”...The FDA is already taking steps to support new technologies that can improve manufacturing and help reduce the chance that supply disruptions will occur...the FDA may want to consider “more significant interventions” than it currently employs. “We want to make sure we aren’t discouraging investment for manufacturing drugs that are more likely to go into shortage, and thus working against our own goals." One suggestion is to grant the FDA authority to require applicants of certain drugs to conduct a “risk assessment to identify the vulnerabilities in their drug supply that could cause a shortage," and to establish risk mitigation plans in advance to address those weaknesses...

NACDS RxImpact pharmacy advocates are urging Senators to sign a letter to Health and Human Services Sec. Alex Azar that...describes the negative effects on Medicare patients and on pharmacies of the rapid expansion of the use of direct and indirect remuneration, or DIR, fees...urging Sec. Azar to not allow the current focus on drug prices to pass without taking meaningful action on this...issue...DIR fees were originally intended to capture and report rebate amounts paid by manufacturers at the end of the plan year during the reconciliation process in Part D. In recent years...the fees have become a catch-all category used increasingly by payers to include various pharmacy price concessions, such as fees related to performance-based programs or fees for participation in a preferred network. As a result, pharmacies find themselves in the untenable position of being paid by plan sponsors for prescription services, only to find out later that some of the payment must be returned...

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.