Posts Tagged “Legal”
Much of the responsibility for the opioid epidemic has been directed at Purdue Pharma, and not without good reason. Purdue introduced OxyContin in the mid-1990s and marketed it aggressively. Its sales representatives lied about its addictive qualities. Its executives downplayed reports of abuse. Its owners grew rich while thousands of people died and countless families were shattered. But documents pried loose last month, thanks to legal action by The Washington Post and the Charleston Gazette-Mail, confirm that there is plenty of blame to go around for the opioid crisis , much of it falling on other drugmakers and distributors.
The data, compiled in the Drug Enforcement Administration’s Automation of Reports and Consolidated Orders System database , shows that from 2006 to 2012 America was saturated with an astonishing 76 billion prescription opioid pills — about 230 for every adult and child in the country. Even as more people became addicted and deaths involving opioids skyrocketed (from 8,048 in 1999 to 18,515 in 2007 to 47,600 in 2017), more companies ramped up the business of making, distributing and dispensing generic forms of powerful painkillers such as oxycodone and hydrocodone. Among drugmakers, Purdue actually ranked fourth (2.5 billion pills) in the ARCOS…
Parents who say their babies were damaged by a pregnancy test drug have warned manufacturers and the government that they are preparing to take legal action. Lawyers representing more than 200 claimants have written letters accusing two drug companies and the UK regulators of being negligent and putting patients at risk. The drug Primodos was given to women in the 1960s and 70s. It was made up of two pills which would induce a period in women who were not pregnant. However, many families believe that if the mother was pregnant, it damaged or even killed their children in the womb. If successful the claim could be worth millions as the alleged victims all suffer with a variety of life-changing difficulties, including limb malformations, musculoskeletal abnormalities, heart defects and brain injuries. Some parents are also claiming still births were caused by the drug.
The proposed legal action follows a Sky News investigation in 2017 where we found documents in German archives showing manufacturers were warned by UK regulators that those using the drug had an increased risk of malformations – and that records from that study appeared to have been deliberately destroyed in order to frustrate any future legal action….
Earlier this month, the Trump administration released its official plan to eventually let Americans import inexpensive prescription drugs from Canada. This is a popular idea that conservatives long resisted, but it has recently caught on among politicians on both sides of the aisle thanks to the growing sense of crisis over U.S. pharmaceutical prices. States including Florida , Maine , Colorado , and Vermont have passed laws to let their residents buy medicine over the border . Democratic presidential candidate Bernie Sanders recently joined a bus caravan of diabetes patients that traveled to Ontario in order to stock up on insulin. (Under current law, U.S. residents are allowed to bring back up to a three-month supply of medication from across the border for personal use.)
But while Americans might like the idea of treating their northern neighbor as one big discount pharmacy, Canadians seem to be less than thrilled by it. There has been concern that large-scale U.S. imports could exacerbate the drug shortages that are already a regular problem in the country. In July, 15 groups representing doctors, patients, and pharmacies sent an open letter to Canada’s health minister warning about the potential problems. “The Canadian medicine supply…
Dr. Steven Curry, a medical toxicologist and professor at the University of Arizona, has treated snakebites since the 1980s — long enough to remember when the treatment represented its own form of misery. The first medication Curry used sometimes caused an immune reaction called serum sickness — patients broke out in a severe, itchy rash. Then, about 20 years ago, the snake antivenin CroFab entered the market and dramatically reduced the adverse reactions associated with treatment, he says.
But the drug came with a sky-high price tag. In one case reported by NPR and Kaiser Health News , an Indiana hospital last summer charged nearly $68,000 for four vials of CroFab. Now, CroFab faces competition from a snake antivenin called Anavip . Curry says the health system he works for in Phoenix — Banner Health — is using the new drug as its first line of treatment. It is switching, he says, because Anavip could reduce readmissions by better controlling bleeding associated with a snakebite and lead to “substantial savings” for the hospital.
But few experts who study drug laws and drug prices expect this competition to reduce the cost for patients. Legal wrangling, the advantageous use of the…
SA’s medicines regulator has warned consumers that all medical products containing cannabis on the local market are illegal, as none have been registered with the authorities.
In a statement issued on Monday, the South African Health Products Regulatory Authority (Sahpra) said the recent Constitutional Court ruling legalising the cultivation and possession of cannabis for personal use did not mean people could use it to manufacture and sell their own medicines.
The court handed down a judgment in September 2018 that declared existing legislation criminalising the use, possession and cultivation of cannabis unconstitutional.
It is therefore no longer an offence for a person to use or be in possession of cannabis in private, or to cultivate the plant in a private place for their personal consumption.
The medicines regulator said that there were a number of outlets and individuals selling cannabis-containing products, including oils, for medicinal use, in contravention of the Medicines and Related Substances Act.
The act says no one may sell medicines that are not registered with the regulator.
“The cannabis-containing products and oils that are currently available in SA and which have not been registered or approved by Sahpra are therefore illegal. Suppliers and users of such illegal…
Frustrated by federal inaction, state lawmakers in 41 states have proposed detailed plans to lower soaring prescription drug costs. Some measures would give state Medicaid agencies more negotiating power. Others would disclose the pricing decisions of the drug manufacturers and the companies that administer prescription drug plans.
The more ambitious proposals would bump up against federal authority, such as legislation that would allow importing drugs from Canada or alter federal statutes on the prices states pay for drugs in Medicaid. They likely would have to survive a challenge in federal court. And many likely would face resistance from a deep-pocketed pharmaceutical industry.
According to the National Institute on Money and Politics, a nonprofit that collects campaign finance data, the pharmaceutical industry in 2018 contributed nearly $19 million to state campaigns, and $56 million to federal ones.
“States are limited in power in this area,” said Rachel Sachs, a health law expert at Washington University in St. Louis School of Law. “But one of the impacts of these efforts is to put pressure on the federal government, and force it to justify its actions to stymie the states.”
President Donald Trump has criticized soaring drug prices, and on Thursday the Department…
The Centers for Medicare and Medicaid Services, part of the Department of Health and Human Services has proposed a reform titled “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses.” Many are arguing for and against the reforms, which some mentioning how HIV care would be threatened.
PhRMA have commented that ‘overall, the changes to the six protected classes should not be finalised: PhRMA strongly opposes proposed changes to the six protected classes policy. The protected class policy affords access to vital and life-saving medicines for patients with serious and debilitating conditions. The administration is proposing to weaken the current six protected class policy in several ways, notably by allowing health plans to force patients who are stable on a medicine to go through prior authorisation or step therapy. We have several concerns with these proposed changes. The proposed changes could have serious health consequences for patients and are unnecessary given that plans already have tools to manage utilisation in these classes and significant savings from the proposed changes are unlikely. We also have legal concerns with the proposed changes, which are inconsistent with Part D’s non-discrimination protections.’
The National Association of Specialty Pharmacy has also…
Since flipping the House of Representatives in last year’s midterms, Democrats have been waiting to see real oversight return to the halls of Congress. That arrived on Tuesday, with the Committee on Oversight and Reform’s first hearing of 2019. But the subject at hand may have disappointed those who were hoping for a dramatic broadside against the Trump administration.
“Our first witness today is not President Trump’s personal lawyer Michael Cohen,” said chairman Elijah Cummings. “It’s not someone from the White House or even the Trump administration… The first witness is Antoinette Worsham.”
Worsham, a working mother from Cincinnati wearing a T-shirt reading “Patients Over Profits,” told the committee about her two daughters, both of whom were diagnosed with Type 1 diabetes. When the oldest, Antavia, turned 21, she was kicked off the Bureau for Children of Medical Handicaps, a state program that helped pay for her insulin. Unable to afford the medication, Antavia began to ration it. Eventually, she died. Worsham’s second child, Antanique, a freshman at the University of Toledo, fears the same fate.
“In two years my daughter will be 21,” Worsham told the committee, her voice cracking. “I am crying out and asking for you to…
Not content with billions of dollars in profits from the potent painkiller OxyContin, its maker explored expanding into an “attractive market” fueled by the drug’s popularity—treatment of opioid addiction, according to previously secret passages in a court document filed by the state of Massachusetts.
In internal correspondence beginning in 2014, Purdue Pharma executives discussed how the sale of opioids and the treatment of opioid addiction are “naturally linked” and that the company should expand across “the pain and addiction spectrum,” according to redacted sections of the lawsuit by the Massachusetts attorney general. A member of the billionaire Sackler family, which founded and controls the privately held company, joined in those discussions and urged staff in an email to give “immediate attention” to this business opportunity, the complaint alleges.
ProPublica reviewed the scores of redacted paragraphs in Massachusetts’ 274-page civil complaint against Purdue, eight Sackler family members, company directors, and current and former executives, which alleges that they created the opioid epidemic through illegal deceit. These passages remain blacked out at the company’s request after the rest of the complaint was made public on January 15th. A Massachusetts Superior Court judge on Monday ordered that the entire document be released, but…
Saudi Arabia is already seeing improvements just two years into a major 14-year plan to overhaul the kingdom’s entire healthcare system, a senior official told The National at the Arab Health Forum.
Dr Mohammed Al Abdulaali, assistant deputy minister for hospital services, said that in “every quarter [last year] the needle moved in the right direction, which gives us an insight that the interventions [already carried out] … are good”.
He said a recently passed rule that food must come with calorie information had captivated public debate in the kingdom and was an example of a change that would have a major impact on consumption habits. He also said that the kingdom was set to launch a new rule about oil and fat content in the kingdom’s cooking in a bid to get people eating healthier.
The kingdom has set itself major development goals as part of a plan called Vision 2030. In health care, the top line is to increase life expectancy from 74 to 80 years old. That, Dr Al Abdulaali said, was “going to be shifting the country from one of the good zones to the best zone countries, which is a very challenging objective but it…