- Nevada is out of the execution business, at least for now (reviewjournal.com)
Dozens of killers are on the state’s death row, but should any of their appeals bottom out, it would be impossible to do away with any of them...One of the two drugs needed to administer an execution by lethal injection in Nevada has expired and the drug manufacturer has refused to provide any further supplies, state officials were told Tuesday...the medication provided by the drug company Pfizer....Without the drug, the state has no way to administer an execution...The department ( Nevada Department of Corrections) is moving forward with a national request for proposals to find the drug or an equivalent...the agency would use the drugs midazolam and hydromorphone to administer a lethal injection...Both of these drugs are manufactured by Pfizer..."Pfizer makes its products to enhance and save the lives of the patients we serve," the company said in a statement issued earlier this year. "Consistent with these values, Pfizer strongly objects to the use of its products as lethal injections for capital punishment."
- Nonprofit seeks to dispel ‘myths’ about how it assesses drug values (statnews.com)
In the face of growing criticism over its efforts to place a value on new medicines, the Institute for Clinical and Economic Review is trying to strike back. Recently, the nonprofit took a conciliatory approach by soliciting suggestions for improving its methods, but this week it became more aggressive by trying to dispel what it calls the “myths” about its operations and motives...The controversial organization released a manifesto...that attempts to rebut its many critics, who have chastised ICER for purportedly having cozy relationships with insurers; failing to sufficiently take into account the views of patients; and not providing enough time for drug makers to respond to assessments...The move comes as ICER has played a behind-the-scenes, but increasingly significant, role in the US health care system over the past two years. In the absence of an official entity to determine the extent to which medicines are cost effective — a function that is played by government agencies in some other countries — ICER has managed to fill the void with its reports...To what extent its attempt to dispel the “myths” will be effective remains to be seen...
- Why the DEA just said ‘no’ to loosening marijuana restrictions
For the fourth consecutive time, the Drug Enforcement Administration has denied a petition to lessen federal restrictions on the use of marijuana...While recreational marijuana use is legal in four states and D.C., and medical applications of the drug have been approved in many more, under federal law, it remains a Schedule 1 controlled substance, which means it's considered to have "no currently accepted medical use" and a "high potential for abuse."...Just this week, the National Conference of State Legislatures, a group representing state lawmakers, called on the federal government to move marijuana from Schedule 1 to Schedule 2. The group criticized federal law for imposing "substantial administrative and operational burdens, compliance risk and regulatory risk that serve as a barrier to banks and credit unions providing banking services to businesses and individuals involved in the cannabis industry."...Despite this, the DEA says it cannot change the legal status of marijuana unless the FDA determines it has a medical use. The FDA cannot determine it has a medical use in part because of the highly restrictive legal status of the drug. It's a classic bureaucratic Catch-22...The only body that can truly resolve this conflict, now, is Congress — by amending the Controlled Substances Act to treat marijuana differently. Most federal lawmakers seem to agree that this needs to happen, but there's disagreement on how to do it...
- Behind rosy predictions, life sciences execs reveal unsettling concerns (statnews.com)
If you ask a life sciences chief executive to gaze into a crystal ball, he or she will tell you there is good reason to be optimistic about the future. Or so a new survey would have us believe....All 38 executives who participated in the survey reported that they are confident about what lies ahead; 79 percent are convinced their products will remain relevant for the next few years; and 97 percent are certain that they are staying on top of coming trends...What might explain such a bullish view of the world? Well, chief executives...by their very nature, tend to be optimistic people and the industry is coming to terms with its challenges...This may be a case, however, of seeing the world through the proverbial rose-colored glasses...Why? At the same time these chief executives are so upbeat, a whopping 89 percent also confessed they are concerned they will not be able to increase market share. And 74 percent expect top-line growth of between just 2 percent and 4 percent over the next three years...We wonder if their investors know how they feel about such prospects.
- Valeant under criminal investigation over Philidor ties: WSJ (fiercepharma.com)
With Valeant’s management assuring investors that the company is well on its way to a turnaround, the drugmaker’s problems aren’t supposed to be growing larger. But now, Valeant is facing what could be its most serious investigation yet...Federal prosecutors are probing the...drugmaker’s relationship with specialty pharmacy Philidor...while that relationship has already garnered plenty of attention from investigators...this particular set of allegations...claim Valeant defrauded insurers by hiding its close Philidor ties--is new....The new probe could also be a bigger threat. Philidor managers and Valeant itself might face criminal charges...Prosecutors are looking into whether the specialty pharmacy made false statements to insurers about its link to the drugmaker. They’re trying to figure out whether insurers thought Philidor--which helped patients snag insurance coverage for pricey Valeant meds--was neutral, rather than in Valeant’s service...
- India’s drug regulator allows concurrent applications for genetic-related trials (fiercepharma.com)
Applications for clinical trials on genetic candidates in India can be sent at the same time to the Drug Controller General of India and the Review Committee on Genetic Manipulation under the Department of Biotechnology as part of an effort to streamline the process...It was decided in the meeting that the applicant may submit parallel application to RCGM and DCGI seeking approval to conduct (a) clinical trial...The RCGM is charged under law with reviewing the safety and ethics of recombinant DNA projects and activities in India that involve genetically engineered organisms, as well as setting guidelines, and previously had the first look at any applications...the change could shorten the path to clinical trial regulatory clearances for insulin or monoclonal antibody candidates...In July, the DCGI tweaked biosimilar approval guidelines and narrowed the scope to issue waivers required to run Phase III trials and rely on clinical references to biologic drugs not marketed yet in the country as part of an effort to get a better handle on data used to support such work.
- This Week in Managed Care: August 13, 2016 (ajmc.com)
Justin Gallagher, associate publisher of The American Journal of Managed Care. Welcome to This Week in Managed Care, From the Managed Markets News Network.
- Can Drug Price Transparency Keep Costs Down? (realclearhealth.com)
Will forcing drugmakers to disclose big price hikes and new high-cost treatments help keep medications affordable for consumers?...That’s the premise behind legislation considered this year in roughly a dozen states...some researchers and consumer advocates say these “drug price transparency” measures likely won’t bring spiraling costs down by themselves — other policy changes will be needed...California state lawmakers will review a bill that would require pharmaceutical companies to give advance notice if they plan to introduce drugs that cost $10,000 or more (per year or per course of treatment) or raise the price on existing medications by more than certain percentages...Proposals...have included requiring pharmaceutical companies to report closely held research and development costs to government agencies, creating pharmaceutical review commissions and allowing government health programs not to cover certain high-priced drugs...Most of the measures have stalled this year, except in California, New Jersey and Pennsylvania, according to the National Council of State Legislatures...If policymakers don’t push to make information available as broadly as necessary to change the drug price conversation...proposed transparency measures risk becoming no more than “PR for policymakers that want to be seen as tough on the drug companies.”
- Direct-to-Consumer Drug Advertising in Oncology Is Not Beneficial to Patients or Public Health (oncology.jamanetwork.com)
Is cancer-related, direct-to-consumer advertising beneficial?—No...In the current communications era, cancer medications, cancer-related genetic testing, and even cancer centers are often marketed directly to the public. While there is little evidence so far that it generates inappropriate treatment recommendations in oncology, cancer-related, direct-to-consumer advertising is prone to cause harm in many other ways. These include potentially fostering patient misinterpretations of expected efficacy and toxic effects of drugs with concomitant harm to the patient-physician therapeutic relationship; encouraging patient interest in new drugs when their toxic effects are not fully appreciated; and failing to present alternative treatment approaches that may be less toxic or costly.
- Pharmacy Week in Review: August 12, 2016 (pharmacytimes.com)
Cate Douglass, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.