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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...

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...

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

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...

Dear Editor:

This saddens me to write this to you. The McGill Drug Store museum has been vandalized a second time and was discovered by Dan Braddock Saturday morning. Rocks the size of bowling balls have been thrown through the windows. There was also damage to some items in the interior.

Windows are something that are replaceable however damage to some items is irreplaceable. The cost of repairs and insurance increases are something that we are having to pull out of our budget when we have other repairs and projects that are more important.

All of us board members are volunteers and there is only one paid staff. We take time away from our families to help preserve items and information from our past. We ask that everyone be vigilant of your surroundings.

If you have any information on this criminal activity please contact the White Pine County Sheriff’s Office.

Thank you to Kirt Braun for boarding up the windows until the new windows get here.

Anyone who is interested in volunteering for the White Pine Public Museum in Ely or the McGill Drug Store museum please call the White Pine Public Museum at 775.289.4710 or stop by at 2000 Aultman Street.

Doctors have additional protocols to consider when writing and maintaining opioid prescriptions under a new law that took effect on New Year’s Day...The Prescription Drug Abuse Prevention Act, passed by the 2017 Legislature, outlines safeguards for doctors before they prescribe controlled substances to treat pain and increases requirements necessary to continue a prescription after one month, three months and a year...The additional paperwork is meant to curb the state’s opioid overdose problem and track down doctors who overprescribe...“It just provides a platform by which the provider can really have an in-depth discussion with the patient as to whether the use of a controlled substance is truly necessary, or whether there are alternatives, ” said Daniel Burkhead, a pain management specialist in Las Vegas...The guidelines require every doctor to perform a patient risk assessment before prescribing a controlled substance to treat pain...Nevada is among 17 states that have enacted legislation limiting the number of days of an initial opioid prescription or capping prescription strength...

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

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.

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

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