- Pharma sales rep regulations proposal stalls in Philadelphia, but the battle’s not over yet (fiercepharma.com)
Big Pharma got a reprieve in Philadelphia last month, but only temporarily...city council paused its proposal to regulate pharmaceutical sales reps when the bill’s co-sponsors pulled it at the final meeting of the year, but they committed to taking it up again in 2019...Councilman Bill Greenlee and Councilwoman Cindy Bass announced they were pulling the proposal before a vote could be taken...and blamed new opposition on the fact that Big Pharma "has unleashed its money and reach to cause hysteria and spread false information.”...Greenlee accused the industry of “bullying” local businesses “when pharmaceutical companies threatened to pull any future medical conventions from the city because of the ‘perception’ of the legislation.”...The proposed “Pharmaceutical Sales and Marketing Practices” gifts and conduct ordinance would regulate pharma manufacturer reps in the city with measures such as having to register with the city, which includes a fee, and prohibiting any gifts to healthcare providers and office staff...follows efforts from other cities such as Chicago, which passed an ordinance to require sales rep licensing that went into effect in July 2017. Nevada also requires pharma manufacturers to submit a list of sales reps working in the state, report gifts or freebies over $10 and provide a list of drug samples distributed...
- Why Big Pharma Cheers Rahm Emanuel’s Exit As Chicago’s Mayor (forbes.com)
Rahm Emanuel’s surprise decision to not run again for Mayor of Chicago next year for a third term may be good news for the pharmaceutical industry, which has become a high-profile target during his tenure...Emanuel was unafraid to put U.S. pharmaceutical companies and their marketing practices in his sights despite Chicago and its suburbs being home to major drug makers that are also big employers like Abbott Laboratories and its spin off Abbvie as well as Baxter International. Other drug makers and startups call Chicago home including Horizon Pharma...Emanuel led the charge for Chicago to introduce an ordinance requiring licenses for drug sales representatives . This summer, Chicago confirmed more than 1,500 licenses, which cost $750 annually, were issued after the first year of the ordinance. Marketing without a license could result in a $1,000 fine...
- EMA Report: Clinical Data Published on 50 Medicines in One Year (raps.org)European Medicines Agency Clinical Data: Online Access to Clinical Data for Medicinal Products for Human Use (clinicaldata.ema.europa.eu)Clinical data publication ( Policy 0070) report Oct 2016 - Oct 2017 (ema.europa.eu)
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...
- Blockbuster Drugs? How About Doing More With What We’ve Got (bloomberg.com)
When it comes to innovation in health care, it's easy to focus on potential blockbuster drugs that hold the promise of flashy cures with billion-dollar sales potential. But a growing crop of research suggests there are also gains to be made by better using drugs we already have...Medical research as a whole is risky, takes time and can be expensive — so it isn’t surprising that studies involving existing drugs often don't get the sort of funding or attention that potentially curative new treatments do. But at a time of spiraling drug prices, they should be a greater priority for governments and other entities interested in keeping down health-care costs without sacrificing patient care...The problem is funding. Pharmaceutical companies have less of an incentive to put their research dollars in these types of studies because there’s rarely fresh profit involved...
- Pat-INFORMED: the solution to drug patent procurement issues? (pharmaceutical-technology.com)
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...
- The Latest: Nevada top doctor has no US medical license (ktvn.com)
The Latest on a court hearings on a pharmaceutical companies lawsuit to stop Nevada from using their drugs for a lethal injection...Nevada's top doctor isn't licensed to practice medicine in the United States...Ihsan Azzam testified in Las Vegas...that he has a master's degree and worked for several years in environmental public health and epidemiology before being named chief state medical officer last May...Azzam says he practiced for several years as an obstetrics and gynecology physician in Africa before moving to the United States in the 1990s...That qualifies Azzam for the job under Nevada state law...Azzam testified that while he has no background in anesthesia or pain management, he says the doses of three drugs proposed for an inmate's lethal injection would be enough to kill a mammoth.
- Drugmakers try evasion, tougher negotiations to fight new U.S. insurer tactic (reuters.com)
In the escalating battle over U.S. prescription drug prices, major pharmaceutical companies are scrambling to limit the economic damage from a new U.S. insurer tactic that coaxes patients away from expensive drugs...The latest move by insurers - which effectively forces drug companies to pay more to assist patients with their copays - is causing a decline in real U.S. drug prices this year, and is expected to become more widely adopted...Drugmakers are working on ways to counter copay accumulator programs, fearing that more employer health plans will adopt them...They include new payment options to evade detection by the pharmacy benefits managers so that a patient still benefits from the financial aid...Larger drugmakers may have the financial flexibility to monitor how these accumulator programs affect revenue over time, while those reliant on a small number of drugs may not be able to wait it out...Drugmakers are also taking a tougher stance when negotiating prices or new discounts for payers, according to insurance industry executives and pharmaceutical consultants...
- As state awaits data from diabetes drug manufacturers, initial report highlights price increases (thenevadaindependent.com)
Pharmaceutical companies are preparing to submit their initial reports detailing why rising prices of some diabetes drugs have outpaced medical inflation, giving state officials the first detailed look into the costs associated with a disease that affects about a tenth of Nevadans...Despite a protracted legal battle...pharmaceutical manufacturers are required to submit reports...to comply with a new diabetes drug transparency law… the state released a list of 175 so-called national drug codes...manufacturers...are required to submit reports to the state detailing the factors that contributed to the price increases...
- Our bipartisan bill will force drug companies to justify ‘drastic’ price hikes (cnbc.com)
Drug companies are making record profits and at the same time raising the prices of life-saving prescription drugs...Additionally, drug companies have no legal obligation to justify or explain the massive spikes in drug prices...the FAIR Drug Pricing Act, a bill that takes the first step in addressing skyrocketing prescription drug prices by requiring basic transparency for pharmaceutical companies that drastically spike the price of a drug...whose initials stand for “Fair Accountability and Innovative Research," would require drug companies to give notice and justification for raising the price of a drug more than 10 percent at one time or more than 25 percent over three years...For each price increase drug companies would have to tell the public what they spent on manufacturing, research and development costs for the qualifying drug, net profits attributable to the qualifying drug, and marketing and advertising spending on the qualifying drug...
- Nevada sets 1st execution since 2006 after fight over drugs (tri-cityherald.com)Judge OKs Nevada execution, but questions about drugs remain (rgj.com)
Dozier's death warrant was signed by Clark County District Court Judge Jennifer Togliatti, who last November blocked the execution over concerns that one drug in the three-drug protocol would immobilize the inmate and mask any signs of pain and suffering. The warrant didn't address her previous concerns..."The (state) Supreme Court never decided whether Mr. Dozier would experience extreme pain, or if he would suffocate to death, or if this protocol is constitutionally adequate," ACLU legal director Amy Rose said Wednesday. She conceded that her group didn't have legal standing to act on Dozier's behalf unless he asks for it...Dozier, 47, has said he wants to die and doesn't really care if he experiences pain. But he did let a team of federal public defenders challenge the drugs and method that Nevada prison officials planned to use...Nevada and other states have struggled in recent years to find drugs after pharmaceutical companies and distributors banned their use for executions...