Pfizer’s Tornado-Damaged Plant Likely To Reopen In A Few Months
The pharmaceutical giant said it has started releasing products from the Rocky Mount, North Carolina, facility that weren't affected by the July 19 storm. Some of the products Pfizer makes at the plant include anesthesia, painkillers, and anti-infective medicines for use in hospitals.
Reuters:
Pfizer Could Restart Production At Tornado-Hit Plant By Early Q4
Pfizer said on Monday it expects to restart production at its North Carolina plant by the beginning of the fourth quarter of 2023 as it seeks to repair tornado damage to one of the world's largest sterile injectable drug facilities. The facility was struck by a tornado on July 19, and Pfizer had earlier said some drugs, including painkiller fentanyl, could see a supply disruption. Pfizer has since placed limits on how much supply of those drugs its customers can buy. (8/28)
Axios:
Adderall Shortage: Renewed Concerns Swirl Ahead Of Back To School
Back-to-school season is sparking renewed concern about the long-running shortage of Adderall and other medicines prescribed for ADHD. It's hard to predict how long drug shortages may last due to limited transparency in the supply chain, but experts note that prescriptions for Adderall historically pick up as students head back to the classroom. (Millman, 8/28)
CIDRAP:
Shortcuts, Coverups In Drug Plants Often Precede Quality Problems, Shortages
When US Food and Drug Administration (FDA) inspectors visited Integra LifeSciences' drug manufacturing facility in Boston in March through May, the company's collagen-based Durepair product failed bacterial endotoxin testing. The FDA issued a warning letter to the company on July 17 for that and other violations of good manufacturing practices (GMP) tied to its wound care, soft-tissue repair, and reconstructive surgery products. Durepair is a nonsynthetic dura mater substitute used in neurosurgery. As a result, the company recalled the Durepair products and issued a statement saying it wouldn't distribute them again until it can conform to quality system regulations, hopefully by the end of the year. (Van Beusekom, 8/28)
In other pharmaceutical industry news —
Stat:
FDA Delays Enforcement Of Law To Stop Counterfeit Drugs
In response to growing complaints, the U.S. Food and Drug Administration has postponed its plans to enforce a law designed to thwart counterfeit or diverted medicines passing through the pharmaceutical supply chain. The law was supposed to be fully enforced in late November, but the agency now says it will not take action until November 2024. (Silverman, 8/28)
Stat:
Insulet Sues Rival For Allegedly Stealing Trade Secrets On Diabetes Tech
Insulet filed a lawsuit this month against its rival EOFlow, accusing it of stealing trade secrets in a case that could shake up the diabetes technology market and throw a wrench in Medtronic’s planned $738 million acquisition of EOFlow. (Lawrence, 8/29)
The New York Times:
Ozempic And Wegovy, Novo Nordisk’s Weight Loss Drugs, Reshape Denmark’s Economy
After 100 years of relatively quiet existence as a maker of diabetes drugs, the Danish firm Novo Nordisk has suddenly grown so big that the company is reshaping the Danish economy. The reason: Ozempic and Wegovy, two weight loss drugs made by Novo Nordisk that have been proclaimed as revolutionary in the field of obesity. (Nelson, 8/28)
KFF Health News:
Epidemic: Speedboat Epidemiology
Shahidul Haq Khan, a Bangladeshi health worker, and Tim Miner, an American with the World Health Organization, worked together on a smallpox eradication team in Bangladesh in the early 1970s. The team was based on a hospital ship and traveled by speedboat to track down cases of smallpox from Barishal to Faridpur to Patuakhali. Every person who agreed to get the smallpox vaccination was a potential outbreak averted, so the team was determined to vaccinate as many people as possible. ... Episode 4 of “Eradicating Smallpox” explores what it took to bring care directly to people where they were. (8/29)