- Where are U.S. drugs really made? A new Senate bill aims to find out (fiercepharma.com)
The vast majority of drugs that make it to American shelves are produced abroad, sometimes in countries that lawmakers worry don't have the nation's best interests at heart. But where are exactly are those drugs produced and how reliant is the U.S. on foreign imports? A new bipartisan Senate bill aims to find out.,,"The coronavirus pandemic has made it painfully clear that we must take decisive action to rebuild our nation's medical manufacturing sector," Rubio said. "This bipartisan bill would ensure policymakers have the necessary information to address our supply chain vulnerabilities, the consequences of foreign investment in U.S. pharmaceuticals, and reduce our over-reliance on China for pharmaceuticals."...The bill would require the FTC and Treasury to produce its report one year after it passes into law...READ MORE
- From Parkinson’s to peanut allergy, pandemic puts brakes on new drugs (reuters.com)
Treatments for peanut allergy and Parkinson’s disease are among U.S. drug launches that have been postponed by the COVID-19 pandemic as drugmakers struggle with disruptions to business...The Food and Drug Administration has approved more than 30 new medicines since January, but at least five drugmakers...have changed their launch plans...Launching drugs is an expensive and complicated process that includes sales representatives talking to doctors, coordinating supplies and treatment with pharmacies and clinics, and advertising campaigns - many of which have become harder during lockdowns or other restrictions to tackle the pandemic...That’s bad news for patients and drugmakers...Delays altogether could cost companies over a quarter of the originally estimated more than $1 billion in 2020 sales for the products approved by the FDA since January...READ MORE
- Gilead’s long-awaited remdesivir price is $3,120, in line with watchdog estimates (fiercepharma.com)
Industry watchers and pharma critics have spent the past two months pitching their calculations on how Gilead Sciences would—and should—price remdesivir after the repurposed antiviral drug became the first to show benefits for COVID-19 patients in a large controlled study...the guessing is over...For private insurance plans, Gilead set a list price of $520 per vial...The cost for a five-day treatment course using six vials, which most patients are expected to receive, would add up to $3,120. For governments of developed countries, including the U.S., the price will be lower, at $390 per vial or $2,340 per course...The prices are roughly in line with those an influential U.S. drug cost watchdog pegged on the drug in its latest cost-effectiveness analysis, but came below the sticker Wall Street was expecting...READ MORE
- Vaccine makers face biggest medical manufacturing challenge in history (reuters.com)
Developing a COVID-19 vaccine in record time will be tough. Producing enough to end the pandemic will be the biggest medical manufacturing feat in history...From deploying experts amid global travel restrictions to managing extreme storage conditions, and even inventing new kinds of vials and syringes for billions of doses, the path is strewn with formidable hurdles, according to Reuters interviews with more than a dozen vaccine developers and their backers...Any hitch in an untested supply chain - which could stretch from Pune in India to England’s Oxford and Baltimore in the United States - could torpedo or delay the complex process...READ MORE
- FCC adds $198M for rural healthcare providers to boost telehealth services (fiercehealthcare.com)
The Federal Communications Commission is adding almost $200 million to a rural healthcare program to help providers buy telecommunications and broadband services...Rural healthcare providers have been hit hard by the COVID-19 pandemic due to the loss in revenue from canceled or deferred elective procedures and the additional expense of personal protective equipment...At the same time, telehealth visits have surged as patients seek virtual care options during the pandemic. The Trump administration lowered regulatory barriers for rural areas. Physicians can care for patients at rural facilities across state lines and via telemedicine...And in many places—particularly rural areas that have the most to gain from telemedicine and connectivity—broadband remains too expensive, unreliable or simply not available at the speeds required to enable innovations in care...READ MORE
- WHO lays out ambitious plan to deliver 2 billion coronavirus vaccine doses (biopharmadive.com)
The World Health Organization, together with partner organizations, aims to secure 2 billion doses of coronavirus vaccines by the end of 2021, unveiling...a creative plan to ensure high-risk groups around the world have access to any vaccine that's successfully developed... Through the WHO's plan, countries would be able to pool their resources to invest in the development a broad portfolio of experimental vaccines, obtaining in return a guaranteed share of the resulting supplies. The idea is to lessen the risk of betting on any one vaccine, while creating a mechanism by which doses are fairly allocated during the initial stages of a vaccine's availability...READ MORE
- Health agency: Data entry error caused bulge in case reports (apnews.com)
Nevada on Saturday reported a record daily increase of additional confirmed COVID-19 cases. But health officials later said the bulge largely resulted from laboratory data entry errors that delayed the posting of hundreds of cases from two previous days...The state Department of Health and Human Services reported an additional confirmed 1,099 cases, mostly from metro Las Vegas...The number of additional cases reported Saturday was more than double the previous record of 507 reported Thursday. Bur the Southern Nevada Health Agency said the reported daily increase included over 600 cases that should have been reported earlier in the week but were not...READ MORE
- FDA will require 50% efficacy for COVID-19 vaccines. How high is that bar? (fiercepharma.com)Development and Licensure of Vaccines to Prevent COVID-19 Guidance for Industry (fda.gov)
Coronavirus vaccine developers now have some advice from the FDA: To win approval, any vaccine must be at least 50% effective in preventing the disease...FDA Commissioner Stephen Hahn plans to roll out that guidance...It sets a bar about on par with a flu shot's performance in a good year—but it falls short of some expert recommendations for arresting the virus' spread...The agency also won’t approve a shot based on its ability to create antibodies in patients’ blood...Despite the urgency of this particular vaccine hunt, the FDA “will not reduce its standards or cut corners in its review to approve a vaccine,”...READ MORE
- High Prices Forcing Americans to Buy Prescription Drugs From Overseas (newsmax.com)Socioeconomic and Demographic Characteristics of US Adults Who Purchase Prescription Drugs From Other Countries (jamanetwork.com)
More than 2 million Americans buy prescription drugs from other countries as a way around rising prices in the United States, a new study finds...The analysis of nationwide survey data showed that 1.5% of adults got their prescription meds from outside the United States between 2015 and 2017...Immigrants and people who were older or who had inadequate health insurance coverage and tight budgets were more likely to do so. Those who use the internet for health care information were, as well, the findings showed...The number of Americans looking for cheaper prescription drugs is likely to rise due to the spike in unemployment stemming from the coronavirus pandemic and the loss of work-based health insurance...READ MORE
- U.S. demand outstripping supply of steroid treatment for COVID (reuters.com)Hospitals see shortages of a cheap steroid that one study says helps Covid-19 patients (statnews.com)FDA Drug Shortages (accessdata.fda.gov)
Soaring hospital demand for the steroid dexamethasone, which British researchers say significantly reduces mortality among severely ill COVID-19 patients, is outstripping supply of the drug, but hospitals have so far been able to treat patients out of their inventories, according to Vizient Inc, a drug buyer for about half of U.S. hospitals...Hospitals and other health-care customers advised by Vizient increased orders of the drug by more than 600% after the researchers announced their findings last week. Manufacturers were only able to fill around half of those orders...dexamethasone reduced death rates by nearly a third among COVID-19 patients requiring mechanical breathing assistance...The injectable version of dexamethasone has been in shortage in the U.S. since February of last year, according to the U.S. Food and Drug Administration...READ MORE