- FDA Sends Warning to Cantaloupe Farm Behind Salmonella Outbreak
- Makers of Brand-Name Opioid Painkillers Fight New Generics
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
FDA Sends Warning to Cantaloupe Farm Behind Salmonella Outbreak
The U.S. Food and Drug Administration has sent a warning letter to the cantaloupe farm tied to a deadly salmonella outbreak last year.
The outbreak sickened at least 260 people across 24 states, killing three people in Kentucky, CBS/AP reported, and the FDA has now warned Chamberlain Farms of Owensville, Ind., to fix unsanitary conditions at its facilities.
According to the FDA, investigators found "accumulated organic material" on conveyors and algae-filled standing water on floors at Chamberlain Farms. Bird droppings were discovered on rafters directly above food products, the FDA added.
According to the FDA letter, "allowing birds to roost in your packing facility could allow them to defecate directly on to food products during conveyance, grading and sorting," CBS/AP reported.
In August, the salmonella outbreak caused federal health officials to warn consumers away from cantaloupes grown in southwestern Indiana, and a DNA test later confirmed Chamberlain Farms as the source. The farm voluntarily recalled its watermelons from the market last September, CBS/AP reported.
Makers of Brand-Name Opioid Painkillers Fight New Generics
As the makers of generic versions of opioid painkillers prepare to bring their cheaper products to market this month, the companies that produce brand-name versions of these powerful medications continue to fight the effort.
According to a report published in The New York Times, both Purdue Pharma and Endo Pharmaceuticals have introduced tamper-resistant versions of Oxycontin and Opana that are difficult to crush or melt, so it's harder for people to abuse the drugs. Both companies claim the move was motivated by concerns for public safety, and the companies have asked the U.S. Food and Drug Administration to require the same tamper-resistant design from the generic drug makers.
So far, their efforts have been stymied. Last month, a federal judge dismissed a lawsuit filed by Endo that would have kept generic versions of its drug, Opana, from going on sale in January. In court papers, the FDA said the lawsuit was a "thinly veiled attempt [by Endo] to maintain its market share and block generic competition," the Times reported.
Dr. Douglas C. Throckmorton, deputy director of regulatory programs at the FDA, told the Times that a guidance is expected to be issued this month that would detail what kind of data would be required to show that a tamper-resistant design would make an opioid painkiller more difficult to abuse.
"We understand the value in developing appropriate abuse-resistant technology, and we want to find a way of incentivizing that," Throckmorton said. "But we also understand the value of generics for patients."
One recent study, funded by Purdue Pharma and published in the Journal of Pain, did find that the number of people treated at drug-abuse clinics who said they had abused Oxycontin fell significantly following the introduction of the tamper-resistant version of the painkiller.
One expert told the Times that the issue is complicated.
"I think it is great that the industry is creating innovative strategies," said Dr. Daniel Alford, a professor at the Boston University School of Medicine. "But these drugs are expensive." He also noted that the labeling of any potentially dangerous drug as being safer could eventually lead to other safety problems.
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