- FDA issues warning letters to websites selling illegal opioids (reuters.com)DEA and FDA warn website operators illegally offering opioids for sale (dea.gov)
The U.S. Food and Drug Administration and the Drug Enforcement Administration jointly issued warning letters to four online networks for illegally marketing unapproved and misbranded versions of opioid medicines, the agencies said...The networks which were issued the warning letters...are Divyata, Euphoria Healthcare Pvt Ltd, JCM Dropship and Meds4U, which operate a total of 10 websites...The networks also violated the Controlled Substances Act by not registering the online pharmacies with the DEA despite advertising for the sale of opioids...READ MORE
- This Week in Managed Care: September 27, 2019 (ajmc.com)
Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- This Week in Managed Care: September 20, 2019 (ajmc.com)
Jaime Rosenberg, welcome to This Week in Managed Care from the Managed Markets News Network
- Pharma’s reputation among Americans sinks to lowest level in decades: poll (biopharmadive.com)
Americans now view big pharma with more distaste than any other industry, according to a new Gallup poll...Just 27% of Americans regarded the pharmaceutical industry positively, compared with 58% who hold a negative view, the poll found. That resulted in a net rating of minus 31, compared with plus 4 just five years ago...Even the federal government — which many Americans love to hate — has a better reputation than the drug industry, which now ranks the lowest out of 25 industries considered by Gallup. More than 1,500 Americans living in all 50 states and the District Columbia were included in the group's poll...READ MORE
- FDA releases revised draft guidance on CDS software, final guidelines on ‘device’ definitions for software such as wellness apps (mobihealthnews.com)
FDA released two guidance documents relating to the regulation of various digital health software devices...The first is a draft guidance outlining categories of clinical decision support products that would or would not require direct regulatory oversight from the agency. This is an update to a CDS draft guidance released in 2017, with the noteworthy addition of a risk-based categorization approach for determining enforcement over these tools...The second is a final guidance that brings several existing medical software policies from the agency into accordance with provisions outlined in 2016’s 21st Century Cures Act. In particular, the document describes certain types of software products that will no longer fall within the agency’s definition of a medical device...READ MORE
- Amid a political firestorm over pharma’s pricing, net prices actually fell last quarter: report (fiercepharma.com)
Politicians and headlines regularly describe U.S. drug prices as “skyrocketing." But new data from analysts at SSR Health show prices haven't been growing as fast as they were—and the amount payers actually shell out is falling...In the second quarter, list prices in the U.S. grew 3.1%, compared with a 4.6% increase during the same period last year. After rebates, prices fell 5.8% during the second quarter, compared with a 6.1% drop after rebates during last year’s second quarter...The net pricing changes typically reflect a mix of increases and decreases across the industry—among various products, companies and market segments—but this time around, “literally no products, companies, or market segments" displayed big net price increases...READ MORE
- September 20 Pharmacy Week in Review (pharmacytimes.com)
Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- Self-translating pharmaceutical labels from Third Aurora could disrupt industry (chaindrugreview.com)
New technology, enabling consumers to read packaging labels written in any language, will become the norm for the pharmaceutical industry within 12 months...A prototype video, shown on the Third Aurora website, demonstrates the solution with a prototype package being translated from English to Spanish, German, Russian, and Japanese...Behind the scenes, two technologies are at work. According to Chaffey, “Artificial intelligence reads and interprets the content and augmented reality projects the new text back onto the label.”...READ MORE
- September 27 Pharmacy Week in Review (pharmacytimes.com)
Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- Walgreens to test drone delivery service with Alphabet’s Wing (cnbc.com)
Walgreens is testing a new on-demand delivery service with Alphabet’s drone delivery service Wing, beginning next month...The pilot program will deliver food and beverage, over-the-counter medications and other items within minutes...Prescription deliveries will not be available...Walgreens will be the first retailer in the U.S. to test an on-demand drone delivery service...READ MORE