- Australia to permit medicinal cannabis exports in bid to capture lucrative market (reuters.com)
Australia said on Thursday it planned to become the fourth country in the world to legalise medicinal marijuana exports in a bid to score a piece of the estimated $55 billion global market...Cannabis cultivation in Australia is still relatively small, as recreational use remains illegal. But the government hopes domestic medicinal use, legalised last year, and exports will rapidly boost production...“Our goal is very clear: to give farmers and producers the best shot at being the world’s number one exporter of medicinal cannabis,” Health Minister Greg Hunt told reporters in Melbourne...Shares in the more than a dozen Australian cannabis producers listed on the local exchange soared after the announcement...The Australian government’s proposal needs to pass federal parliament when it returns to session in February. The country’s main opposition Labor Party has signalled it would support the move.
- Drugmakers raise 2018 U.S. prices, stick to self-imposed limits (reuters.com)
Drugmakers opened the new year by raising U.S. prices on dozens of medicines, but early data showed the increases generally remained within a 10 percent self-imposed limit in response to a backlash from consumers and politicians...“Drug price increases are somewhat more constrained in 2017 and 2018 than they have been previously,”...Allergan Inc raised prices on 18 different drugs...by 9.5 percent...Other drugmakers raising prices include Amgen Inc, Teva Pharmaceutical Industries Inc and Horizon Pharma...Drug price increases are coming under more scrutiny from states. California Governor Jerry Brown in October signed legislation requiring drug manufacturers to give 60-day notice if prices are raised more than 16 percent over a two-year period...
- New drug approvals hit 21-year high in 2017 (reuters.com)
U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light -- more than double the previous year -- while the figure also rose...in the European Union...recommended 92 new drugs including generics, up from 81...Yet the world’s biggest drugmakers saw average returns on their research and development spending fall, reflecting more competitive pressures and the growing share of new products now coming from younger biotech companies...projected returns at 12 of the world’s top drugmakers were at an eight-year low of only 3.2 percent...
- 2017 was a big year for FDA digital health regulations (healthcareitnews.com)
With a new administrator at the helm, the U.S. Food and Drug Administration took steps toward regulating decision support, software-as-a-medical-device, mobile tech in clinical trials and more...the FDA had a full plate in 2017 as it sought to revise its regulatory processes for the shifting healthcare landscape...the new guard already had announced and implemented a firm-focused pre-certification program, released new guidances addressing provisions of 2016's 21st Century Cures Act, and outlined a handful of other ongoing initiatives that are sure to impact the digital health industry. Here's a rundown of the agency's actions and announcements during 2017.
- New leadership, new approaches
...a plan that included clear language on which devices the agency would look to regulate, an app regulation strategy involving postmarket data collection, and other idea designed to streamline the approval process...FDA opened up applications for a pilot of a firm-focused digital health pre-certification program...nine companies selected to participate: Apple, Samsung, Verily, Pear Therapeutics, Tidepool, Phosphorus, Fitbit, Roche, and Johnson & Johnson...draft of the long-awaited and somewhat controversial guidance on clinical decision support, which laid out the forms of clinical decision support that would or wouldn't be regulated based on the degree of human involvement (as opposed to risk)...draft guidance describing the FDA's new Breakthrough Devices Program...would supersede the Expedited Access Pathway and aims to push novel technologies presenting a significant improvement over status quo through the clearance process more quickly.
- FDA shifts toward digital, patient feedback
...the Clinical Trials Transformation Initiative – a public-private partnership of pharma companies, academics, and regulators including the FDA – released new endpoint recommendations for the use of mobile technologies in clinical trials... The guidelines, meant to be the first in a series of such documents, included suggestions for study designers when selecting novel endpoints, practical approaches when developing these endpoints...
- New leadership, new approaches
- Philippines fines Sanofi, suspends clearance for Dengvaxia (reuters.com)Families target Philippine officials and Sanofi executives with request for criminal charges (fiercepharma.com)
The Philippines has fined Sanofi $2,000 and suspended clearance for the French drug maker’s controversial dengue vaccine Dengvaxia, citing violations on product registration and marketing, its health secretary said on Thursday...Concerns over the dengue immunization of nearly 734,000 children aged nine and above resulted in two Philippine congressional inquiries and a criminal investigation as to how the danger to public health came about...The country ordered Sanofi to stop the sale, distribution and marketing of Dengvaxia after the company last month warned the vaccine could worsen the disease in some cases...The Food and Drugs Administration of Philippines found Sanofi violating post-marketing surveillance requirements...
- Pharma, under attack for drug prices, started an industry war (washingtonpost.com)
It’s not easy to get Americans mad at a behind-the-scenes industry they’ve barely even heard of, but pharmaceutical companies have spent most of this year trying...With national and state advertising campaigns, white papers and cartoon infographics, the powerful and well-funded drug-industry lobby spent 2017 working to redirect public anger about drug prices to pharmacy benefits managers: links in the supply chain that sits invisibly between the patient and the drugmaker — in the process bringing a long-simmering feud between two big health-industry players into the open...the drug companies’ fight with PBMs and insurers has helped thwart any real action — splintering the problem into a multi-industry echo chamber of accusations that’s hard to comprehend, much less solve...“This has been a year of finger-pointing,”...“They’re flooding the zone — with ‘they’ being pharma — with efforts to diffuse and deflect the focus on their role in drug pricing. Part of the policy challenge is they have a point.”
- Families target Philippine officials and Sanofi executives with request for criminal charges (fiercepharma.com)
The Dengvaxia debacle in the Philippines just keeps heating up, as more than 70 mothers with vaccinated children filed for criminal prosecution against former officials, including ex-President Benigno Aquino III, and Sanofi executives...In their legal complaint, which asks prosecutors to consider criminal charges, the families targeted Aquino, former Department of Health chief Janette Garin, M.D., and two other government officials, as well as five Sanofi executives including CEO Olivier Brandicourt and Asia-Pacific head Thomas Triomphe...Invoking the country’s Anti-Graft and Corrupt Practices Act, the families claim that the government officials are “guilty of gross inexcusable negligence” for rolling out the program without due diligence...adding that they gave “excessive accommodations” to the global drug giant. The families also questioned “whether [Aquino] acted in conspiracy with Sanofi officials” in purchasing about $70 million worth of Dengvaxia doses...after Sanofi released results from a new analysis indicating that its vaccine could cause more serious infections if given to those who haven't previously encountered dengue. The country immediately stopped its mass vaccination program, and government officials took a tough tone with the company
- In Israel, Teva has become more than just a drug company. But its future is now in question (statnews.com)
...the company (TEVA) is at a crossroads — one that is raising questions not only about the consequences for...across Israel but about its very identity...Last month, tens of billions of dollars in debt, Teva announced that it would undergo a massive restructuring, laying off a quarter of its workforce and closing plants all over the world. Faced with the prospect of 1,750 job cuts in Israel, protesters across the country took to the streets, burning tires and shutting down major roads in Jerusalem and Tel Aviv...Teva had said it might sell the plant in Kiryat Shmona, not shut it down, but workers here didn’t know if they would keep their jobs and, if so, how they might be affected....“It’s a combination of, you know, the disappearance of their largest product, Copaxone, [and a] broader erosion of the generics business,” said Ronny Gal, a financial analyst at Sanford Bernstein...He said that Teva’s financial situation also stems from its failure to adapt to the changing landscape...“The company is in a very challenging situation,”...detailing Teva’s tribulations. “I have found that our current business reality requires immediate and significant action to ensure the company’s future.”...That meant cutting 14,000 jobs around the world as well as shedding plants; in Israel that would include closing one facility in Jerusalem and trying to sell others...the company is at a crossroads — one that is raising questions not only about the consequences for this city and others across Israel but about its very identity...
- Lawsuit dismissed: $1.6B cut to hospitals’ 340B payments takes effect (advisory.com)
A federal judge...dismissed a lawsuit seeking to block CMS from implementing a $1.6 billion cut to hospital reimbursements under Medicare's 340B drug discount program—although hospital groups suggested they may take further legal action to try to reverse the cuts...The lawsuit's dismissal meant CMS could implement the cuts as scheduled on Jan. 1...hospital groups argued the cuts could jeopardize services at safety-net hospitals...HHS in a motion to dismiss the lawsuit claimed that hospitals had "reaped substantial profits" from subsidies under the 340B program's previous system...U.S. District Judge Rudolph Contreras in his ruling said the hospital groups lacked standing...hospitals filed the suit prematurely since the rule did not take effect until Jan. 1, adding that the groups will have to reference specific reimbursement claims to move forward with a lawsuit.
- FDA Proposes Crackdown on Risky Homeopathic Drugs (ptcommunity.com)
The FDA is proposing a new risk-based enforcement approach to homeopathic drug products. Among the targets: products marketed for serious diseases without showing clinical benefits, products that contain potentially harmful ingredients, and products that don’t meet current good manufacturing practices...homeopathic drug products are subject to the same requirements related to approval, adulteration, and misbranding as any other drug product. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the agency’s enforcement policies since 1988...“In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer,” said FDA Commissioner Scott Gottlieb...“In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse—that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren’t adequately tested or disclosed to patients...The FDA intends to focus its enforcement authorities on the following kinds of products:
- Products with reported safety concerns
- Products that contain or claim to contain ingredients associated with potentially significant safety concerns
- Products for routes of administration other than oral and topical
- Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions
- Products for vulnerable populations
- Products that do not meet standards of quality, strength, or purity as required under the law