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Novartis CEO Vas Narasimhan said the company “thoroughly, aggressively” investigated whether the issue would effect patient safety. The FDA, after publicly rebuking the company, came to a similar conclusion that patients aren’t at risk because of the lapse in judgment. Other pharmaceutical industry news looks at Gilead’s pricey HIV drug, cell therapies, the cost of a snakebite, and more.
CMS Administrator Seema Verma said the decision should clear up “a lot of confusion” about coverage and will help patients get access to the novel therapies. The treatment costs $375,000 or $475,000, depending on whether it is used for advanced lymphoma or pediatric leukemia.
Officials say the issue doesn’t put patients at risk, but the drugmaker could face penalties for withholding the information. The news has also unsettled an industry where many are racing to be the first to come out with these expensive gene therapies.
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Innovative Medicines Canada has in early drafts even urged the country to ban drug exports “unless otherwise permitted by regulation.” The group’s efforts suggest the industry is eager to derail the Trump administration’s plan to allow Americans to import cheaper drugs from their northern neighbor.
Unlike other treatment facilities, it doesn’t require training or any kind of license to open a sober home. In that unregulated environment, bad actors have been taking advantage of a population of vulnerable recovering addicts. In other news on the crisis: the legal cases against drugmakers, a look at the areas where opioids flooded in the most, and more.
The legislation would require drugmakers to inform the state and give justification for their price hikes. The judge is allowing the industry to proceed with the argument that the law is unconstitutional because it violates interstate commerce and free speech principles.
Although President Donald Trump’s plan to allow some importation of prescription drugs from Canada is popular in the United States, those in our neighbor to the north are concerned it will cause shortages for them.
In an about-face, HHS Secretary Alex Azar touted the administration’s openness to the idea that importing drugs from Canada can help make them more affordable to Americans. The plan would allow state governments, pharmacies and drug manufacturers to come up with proposals for safe importation and submit them for federal approval. Some lawmakers and experts welcome the proposal as a first step, but others were disappointed. “This is kind of a distraction from the real issue, and the real problem,” said Elizabeth Rowley, the founder and director of T1International, a diabetes advocacy group. “Which is pharmaceutical companies are setting costs at exorbitant rates and patients are suffering and dying.”
Health care once again took center stage at the second night of the latest round of 2020 Democratic presidential debates. Front-runner candidates former Vice President Joe Biden and Sen. Kamala Harris (D-Calif.) scuffled over their health plans — with Biden arguing that the Affordable Care Act should be built up while Harris backed a more progressive expansion of Medicare. Their arguments echo a larger fight within the party over where to go next with health care. Media outlets offer in-depth coverage of the debate night from fact checking dubious figures to taking a look at where the other candidates stand on the issue.
The “pay for delay” agreements involve one company paying other drugmakers to refrain from producing a generic version after the drug’s patent expires. The practices caused consumers “to pay as much as 90% more for drugs shielded from competition,” state Attorney General Xavier Becerra’s office said. Four settlements were reached with drug companies Teva Pharmaceutical Industries, Endo Pharmaceuticals and Teikoku Pharma. Meanwhile, Pfizer confirms its reported plans to absorb Mylan.
The deal, if completed, could be announced as early as Monday. The deal would bring together two businesses whose sales have slowed since former big sellers lost patent protection and began facing lower-priced competition. In other pharmaceutical news: black box warnings, antibiotics, and biotech’s burning questions.
Sen. Bernie Sanders (I-Vt.) led a group of people buying insulin across the border into Canada where a vial of the drug costs about a tenth of what it does just an hour away in Michigan. Sanders has long hammered the point that corporate greed is driving prices sky-high.
Sen. Kamala Harris (D-Calif.), a 2020 presidential hopeful, splits the difference between the plans from rivals Sen. Bernie Sanders (I-Vt.) and former Vice President Joe Biden. Her plan would give consumers a choice of joining a government plan modeled on Medicare or choosing from insurance policies modeled on those in Medicare Advantage, and would be run by private insurers rather than the government. “If they want to play by our rules, they can be in the system. If not, they have to get out,” Harris said of the insurance companies. Her shifting position on whether they would be included in her health plan has brought her criticism in the past.
Court cases over the opioid epidemic are putting an embarrassing spotlight on McKinsey’s strategic advice that’s usually kept strictly behind a curtain. One lawsuit stated that McKinsey advised a pharmaceutical company to “get more patients on higher doses of opioids” and study techniques “for keeping patients on opioids longer.” In other news on the epidemic: Sen. Rob Portman (R-Ohio) rails against companies that he says have hurt Americans through the crisis, the Massachusetts attorney general is investigating a pharmacy over improper prescriptions for opioids, and more.
In particular, a provision that would cap drug prices paid by Medicare based on the rate of inflation has sparked some pushback even among Republicans who voted to advance the long-awaited bill. And Democrats, who unanimously voted to advance the bill, may still kill it. Senate Finance Chairman Chuck Grassley (R-Iowa) is trying to make the case that lawmakers may not like his bill, but they’ll dislike what the Trump administration and House Democrats come up with more.
“Other developed nations assessed drugs based on value … but the U.S. remains one of the few developed nations that doesn’t,” said Alexander Egilman, a researcher at Yale. “We all say we spend too much on drugs, and this approach seems to be working for other countries, based on outcomes, such as lifespans. So why aren’t we considering this?” In other pharmaceutical news: dark money, former FDA chief Scott Gottlieb’s new position, off-label marketing practices, and more.
According to reporting from Reuters, sources say the proposal would be much broader than the administration’s previously disclosed proposal to lower prices on physician administered, or Part B, drugs by tying prices to lower costs in other countries.
The bipartisan proposal released from the Senate Finance Committee this week has won praise from a number of Washington’s loudest drug pricing advocates, but the magnitude of the proposal has even some of Washington’s most outspoken drug pricing experts grappling with its long-term implications. Meanwhile, HHS Secretary Alex Azar is throwing his weight behind the legislation.